Clinical Research Directory

Musical Intervention for Dental Anxiety

The goal of this clinical trial is to learn if listening to music during dental procedures lowers anxiety in adults. The main questions it aims to answer are: does music during the procedure lower dental anxiety, and does wearing headphones without audio to reduce ambient noise also lower dental anxiety. Researchers will compare three groups to see these effects: music via headphones, headphones without audio, and standard care without headphones or music. Participants will: * Complete a short anxiety questionnaire before the dental procedure. * Receive one of the three approaches during the procedure: music via headphones, headphones without audio, or no headphones/music. * Complete a short anxiety questionnaire after the dental procedure.

Evaluation of the Effects of Virtual Reality Applications on Salivary Cortisol Levels and Vital Signs in Adults With Dental Anxiety During Restorative Dental Treatments

In this study, adults selected using an MDAS score ≥13 received a combined visual and auditory distraction intervention during restorative treatment. Salivary cortisol and vital signs were measured before and after treatment, and patients rated how they felt after treatment; subjective anxiety was not reassessed. The aim of this study was to evaluate the effect of a VR-assisted audiovisual intervention on acute physiological stress responses and patient-reported post-treatment feelings in adults with dental anxiety undergoing restorative procedures. MDAS was used only to characterize eligibility at baseline; post-intervention subjective anxiety was not assessed.

Effect of Audiovisual Distraction on Dental Anxiety and Heart Rate During Root Canal Treatment

Dental anxiety is common among patients undergoing root canal treatment and may negatively affect their experience during dental care. Audiovisual distraction, combining visual entertainment with sound delivered through headphones, may help reduce anxiety by redirecting patients' attention away from the dental procedure. The purpose of this randomized clinical trial was to evaluate whether a ceiling-mounted audiovisual entertainment system could reduce dental anxiety and heart rate during root canal treatment in patients diagnosed with symptomatic irreversible pulpitis. A total of 100 adult patients were allocated to two groups. Participants in the intervention group received root canal treatment while watching audiovisual entertainment on a ceiling-mounted screen and listening through headphones. Participants in the control group underwent conventional root canal treatment without audiovisual entertainment. Dental anxiety and heart rate were assessed at four predefined time points during the treatment appointment. The study compared changes in these outcomes between the two groups to determine whether audiovisual distraction could improve the patient experience during endodontic treatment.

Effects of Different 432 Hz Auditory Stimuli on Physiological Stress Responses and Patient Satisfaction in Adults With Dental Anxiety During Restorative Treatment

In this four-arm randomized controlled clinical trial, 120 adults aged 18-50 years with baseline Modified Dental Anxiety Scale scores ≥13 were allocated equally to 432 Hz-based instrumental music, water sounds, human-vocal music, or a no-audio control during standardized restorative cavity preparation. Heart rate, systolic and diastolic blood pressure, peripheral oxygen saturation, and body temperature were recorded before and immediately after preparation; patient satisfaction was assessed after restoration. Physiological outcomes were compared using baseline-adjusted analysis of covariance, with Holm-adjusted pairwise comparisons. The null hypothesis was that there would be no significant differences among the four study groups in changes in physiological parameters or post-treatment patient satisfaction. The alternative hypothesis was that at least one auditory intervention condition would differ from the other study conditions in physiological responses and/or patient satisfaction.

Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment

Some people feel pain after a root canal treatment. This study will test whether intracanal cryotherapy, a final rinse of the tooth with cold sterile saline, can reduce this pain compared with a room-temperature rinse. Previous studies have suggested that intracanal cryotherapy may reduce pain after root canal treatment. This study will examine the effect of cryotherapy in a defined group of patients and explore how cryotherapy works. The investigators will measure the level of irisin, a substance with reported anti-inflammatory properties, in saliva to see whether cryotherapy changes the irisin level. The study will also look at whether a person's tendency to worry about pain (pain catastrophizing) changes the effect of cryotherapy on pain, and whether dental anxiety is related to pain after treatment. Adults aged 18 to 65 who need root canal treatment on a single-rooted lower premolar tooth will receive standard single-visit treatment. By chance, 100 participants will be placed in a cold-saline group or a room-temperature-saline group. Thirty healthy volunteers will give one saliva sample for comparison. Participants will complete questionnaires before treatment, rate pain over the 7 days after treatment, and give saliva samples for irisin measurement. The main questions this study aims to answer are: Does intracanal cryotherapy lower pain after root canal treatment? Does intracanal cryotherapy change salivary irisin levels? Does pain catastrophizing change the effect of cryotherapy on pain? Is dental anxiety related to pain after treatment?

Virtual Reality Distraction During Restorative Dental Treatment

This split-mouth randomized clinical trial will evaluate the effect of virtual reality (VR) distraction on pain perception, anxiety, physiological responses, and patient experience during local anaesthesia administration and restorative dental treatment in adults. Participants requiring bilateral Class I restorative treatment will receive treatment with and without VR distraction in randomized order. Pain, anxiety, heart rate, oxygen saturation, and patient-reported experience will be compared between the two conditions to determine whether VR improves patient comfort during routine dental care.

Effect of Music on Dental Anxiety in Children: Turkish Validation of the CEDAM

The study will consist of two phases. In the first phase, the validity and reliability of the children's experiences of dental anxiety measure (CEDAM) scales will be assessed in children aged 9-16 years using item analysis, content and construct validity, internal consistency, and test-retest reliability. In the second phase, the effect of music will be evaluated in a randomized controlled trial involving children aged 9-12 years. The study will employ a three-session design with progressively increasing procedural invasiveness. In the final session, the control group will receive basic behavior guidance, while the intervention group will additionally listen to music during the dental procedure. Perioperative anxiety will be assessed using the Children's Anxiety Meter-State (CAM-S), Children's Emotional Manifestation Scale (CEMS), and short version of the CEDAM (CEDAM-8). A conceptual model will be used to examine the relationships between music intervention, preoperative anxiety, intraoperative anxiety, and postoperative anxiety.

Dental Anxiety in Children Attending Emergency Versus Routine Dental Care

The goal of this observational study is to learn whether children who come to a pediatric dental emergency clinic have higher dental anxiety than children who come for routine dental care. The study includes children aged 2 to 13 years attending the Department of Pediatric Dentistry at Marmara University in Istanbul, Turkiye. The main question it aims to answer is: Do children attending an emergency dental visit (because of dental pain, abscess, facial swelling, or dental trauma) have higher dental anxiety scores than children attending a routine dental visit? Researchers will also look at whether dental anxiety is related to age, sex, previous dental visits, previous local anesthesia, and tooth decay experience. Participants will: * Have a parent or guardian fill out a short form about the child's age, sex, and dental history * Receive a routine dental examination to record tooth decay (dmft/DMFT index) * Answer the 4-question Turkish version of the Corah Dental Anxiety Scale during a single visit No extra treatment or intervention is given as part of this study.

Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery

Preoperative anxiety and loud equipment noises, such as dental drills, create significant stress and autonomic fluctuations in patients undergoing oral surgery. Brainwave entrainment using alpha-band (10 Hz) binaural beats is a non-invasive audio method designed to promote relaxation and activate the parasympathetic nervous system. The purpose of this randomized controlled clinical trial is to evaluate the clinical effectiveness of a 10 Hz alpha-band binaural beat track embedded in continuous rain sound on reducing perioperative anxiety, maintaining hemodynamic stability, and improving postoperative recovery in patients undergoing impacted third molar extraction. Fifty-four healthy adult participants (ASA I) scheduled for impacted third molar surgery will be randomly assigned into three groups:Binaural Beats Group: Listening to 10 Hz alpha binaural beats embedded in a rain sound via active noise-cancelling (ANC) headphones during surgery. Placebo Group: Listening to rain sound only via ANC headphones during surgery. Active Control Group: Wearing ANC headphones with no audio broadcast (noise cancellation feature only). Preoperative dental anxiety, hemodynamic parameters (blood pressure, heart rate, oxygen saturation) at four distinct intraoperative stages, post-surgical stress levels, and 7-day postoperative pain/analgesic consumption will be measured and compared among the groups.

Effect of Music on Dental Anxiety and Physiological Responses During Dental Drill and Suction Sounds

Dental anxiety is common and may be triggered or increased by sounds associated with dental treatment, particularly the sound of a dental drill and suction device. Anxiety during dental care may be associated with changes in physiological responses such as heart rate and blood pressure. This randomized controlled clinical trial will investigate whether listening to music can reduce dental anxiety and physiological responses when participants are exposed to dental drill and suction sounds. Participants will be randomly assigned to either a music group or a control group. Participants in the music group will listen to selected music during exposure to the dental sounds, while participants in the control group will undergo the same sound exposure without music. Dental anxiety will be assessed using a validated anxiety assessment tool, and physiological responses will be measured before, during, and/or after exposure to the dental sounds. The study will compare changes in anxiety and physiological measures between the music and control groups. The findings may help determine whether music is a simple, non-invasive approach for reducing anxiety and physiological responses associated with dental sounds and may contribute to improved comfort during dental care.

Passiflora Incarnata for Dental Extraction Anxiety

This study looks at whether Passiflora incarnata (passionflower extract) can help reduce anxiety before tooth extraction. Male participants who feel high anxiety before the procedure will receive either passionflower extract or an inactive substance (placebo) before their extraction. Neither the participants nor the researchers will know who receives which one. The study will compare anxiety levels using a questionnaire, along with body responses such as heart rate and blood pressure. The goal is to find out whether this natural option could help patients who fear tooth extraction, without the use of medication

Compare the Intensity of Pain Felt by Children During the Local Anesthesia Procedure to That Perceived by the Accompanying Parent.

The goal of this observational study is to compare the intensity of pain experienced by children (aged 6 to 15) during local anaesthesia with that perceived by the parent accompanying them. The main question it aims to answer is: Can a parent help assess their child's pain when the child is unable to assess it themselves? A preliminary study carried out in the dentistry department of Clermont-Ferrand University Hospital in 2019 showed that parents could be effective external assessors in distinguishing between pain and anxiety in their own children, whom they know well, and were better at this than dentists, who are more prone to errors of judgement.13 This pilot study covered several dental procedures, including pulpotomy, extraction of a primary tooth, curettage of a carious lesion and dental anaesthesia. The study yielded interesting results but also contained some biases, so the investigators would like to improve upon it. To do so, the focus here is on a single therapeutic procedure: local anaesthesia, which is one of the procedures most feared by children and, very often, by the parents accompanying them as well. Once consent has been obtained from both parents (or legal guardians), two questionnaires will be used. The first will consist of simple questions and will be aimed at the children (9 items). The second (20 items) will be for parents and will provide additional information on the child's state of health and on the parents' anxiety regarding their own dental care and that provided to their child. The main aim of both questionnaires will be to assess the intensity of pain perceived by the child during the administration of local anaesthesia, with the child self-reporting their pain and the parent providing an external assessment. These questionnaires will be completed every Wednesday, which allows a child (requiring multiple treatments) to complete the questionnaires several times, thereby enabling us to observe changes in the pain perceived by the child and their accompanying parent over the course of successive anaesthetic procedures.

Virtual Reality Storytelling Versus Storybook Reading for Dental Anxiety in Children

Many children feel anxious before dental treatment. This study compares two ways of helping children feel calmer while waiting for their dental visit: watching a dental story through virtual reality (VR) glasses, or listening to the same story read aloud by the dentist from a printed storybook. The story is in Arabic and follows a girl named Amira during her first dental visit. The story is identical in both groups, so the only difference is how it is delivered. Healthy children aged 6 to 10 years will be randomly assigned to one of the two groups. The main outcome is the child's heart rate, measured before and after the story as an objective sign of anxiety. Children's dental fear will also be assessed with two child-friendly scales, and parents' own dental anxiety will be measured to see whether it is related to their child's anxiety. The study aims to find out whether VR storytelling differs from a traditional storybook in its effect on children's anxiety before dental treatment.

Virtual Reality Audiovisual Distraction During Pediatric Dental Treatment

Dental anxiety is common in children and may interfere with cooperation during dental treatment. Audiovisual distraction using virtual reality glasses may help redirect attention away from dental stimuli and improve the patient experience. This completed prospective non-randomized controlled clinical study evaluated the effect of virtual reality audiovisual distraction on anxiety-related variables in pediatric patients undergoing dental treatment at the Dental Clinic of Universidad Europea de Madrid. Participants received either standard dental care without audiovisual distraction or standard dental care while using virtual reality glasses during the procedure. Dental anxiety was assessed using the Modified Facial Image Scale. Heart rate and peripheral oxygen saturation were recorded using pediatric pulse oximetry. Behavioral response was assessed using the FLACC scale. Measurements were taken before, during, and after dental treatment; in the virtual reality group, additional measurements were collected while the child was using the glasses and after the glasses were removed. This record was submitted after completion of participant enrollment and data collection for retrospective public registration.

Virtual Reality to Reduce Anxiety in Adults Having Lower Wisdom Tooth Surgery

This randomized controlled trial will evaluate whether immersive virtual reality can reduce anxiety in adults undergoing surgical removal of mandibular third molars under local anesthesia. A total of 120 participants will be assigned to either an immersive virtual reality group or a standard-care control group. Participants in the virtual reality group will use a Meta Quest 3 headset displaying relaxing natural scenery beginning 2-3 minutes before local anesthesia and continuing through completion of surgery. Both groups will undergo the same standardized surgical protocol. The primary outcome is state anxiety during surgery, assessed using the State-Trait Anxiety Inventory-State scale (STAI-S). Secondary outcomes include intraoperative pain and immediate postoperative satisfaction. Additional measures will assess postoperative pain, swelling, mouth opening, wound healing, analgesic use, adverse events and acceptability of virtual reality.

Multisensory Approaches for Managing Pediatric Dental Anxiety

The purpose of this prospective, randomized, single-blind clinical study is to evaluate and compare the effectiveness of distraction using virtual reality (VR) glasses and deep-pressure stimulation using weighted blankets on dental anxiety, cooperation, and pain perception in school-aged children. The study focuses on children aged 5-9 years with high dental anxiety (CFSS-DS score ≥39) who require dental procedures involving local anesthesia, such as Class II restorations, pulpotomy, or extractions. Participants will be randomly assigned to four groups: a control group receiving standard behavior guidance, a VR group, a weighted blanket group, and a combined group using both VR and weighted blankets. The study aims to determine the effects of these non-pharmacological, non-invasive, sensory-based interventions on children's clinical experience and physiological parameters.

Intranasal Dexmedetomidine for Severe Dental Anxiety: a Randomized Trial

Patients with dental anxiety only develop anxiety and fear about dental treatments. Patients with severe dental anxiety have difficulty cooperating with dental treatments, and can only complete dental treatments through general anesthesia, or even abandon treatments. Dexmedetomidine is a potent, highly selective α2-adrenoceptor agonist, which provides good anxiolytic, sedative and analgesic effects and is commonly used in anesthesiology and intensive care medicine departments, routinely intravenously. In recent years, intranasal administration of dexmedetomidine has also been reported for pediatric dentistry and adult alveolar surgery, showing good sedative and analgesic effects. However, these studies have problems such as single surgical types, small sample size, and few indicators analyzed. Therefore, the evaluation of intranasal administration of dexmedetomidine is still not comprehensive enough. Besides, the anxiolytic effect of dexmedetomidine for dental anxiety has not been reported yet. This project plans to carry out a randomized, double-blinded, placebo-controlled, two-stage clinical trial. We will firstly explore a reasonable dose, and secondly verify it with placebo as the control. We plan to measure the object indicators, including the NTI value, plasma cortisol, interleukin-6, blood pressure and heart rate, and to assess the subjective indicators using scales and questionnaires, thus comprehensively evaluating the effectiveness, safety and feasibility of the anxiolytic effect of intranasal dexmedetomidine for severe dental anxious patients, and preliminary exploring its mechanism additionally. We intend to help severe dental anxious patients completing dental treatments.

Music Therapy to Improve Dental Procedure Tolerance and Reduce Distress in Adults With Intellectual and Developmental Differences

Adults with intellectual and developmental differences may experience behavioral distress, sensory sensitivity, and difficulty tolerating dental procedures. This pilot randomized controlled trial will compare live music therapy delivered by a board certified music therapist with recorded music during non emergency dental procedures performed under local anesthesia. Approximately 50 participants will be enrolled to obtain 40 evaluable participants randomized in a 1:1 ratio. The study will evaluate the feasibility and acceptability of live music therapy and its preliminary effects on behavioral cooperation, procedural distress, physiological responses, completion of dental treatment without escalation to sedation, and procedure duration.

Behavioural Acceptability of PARO in Paediatric Dentistry : a Descriptive Observational Study

Socially assistive robots are increasingly being studied as tools to support children during healthcare procedures. This observational study aimed to assess the behavioural acceptability of the PARO therapeutic zoomorphic robot, designed in the form of a baby seal, during dental treatment in children aged 4 to 15 years with cooperation difficulties following unsuccessful conventional behavioural management. Behavioural acceptability was assessed by measuring the proportion of the dental treatment session during which the child voluntarily maintained physical contact with PARO. High behavioural acceptability was defined as voluntary physical contact maintained for at least 75% of the treatment time. The study also assessed changes in the children's behaviour during the dental appointment, their spontaneous reactions to PARO, and the perceptions of the children, their carers and the dental practitioners."

Digital Storytelling-Based Animation for Preoperative Anxiety in Children

This randomized controlled trial evaluates the effect of a digital storytelling-based animation on preoperative anxiety and physiological parameters in children aged 5-12 years undergoing dental treatment under general anesthesia. Participants are randomly assigned to either an intervention group, which watches a digital storytelling-based animation before the procedure, or a control group receiving standard preoperative care. Anxiety is assessed using the Modified Child Dental Anxiety Scale-Faces (MCDAS-F) and Facial Image Scale (FIS). Physiological parameters, including heart rate, blood pressure, respiratory rate, and oxygen saturation, are also evaluated. The study aims to determine whether the animation-based intervention reduces preoperative anxiety and physiological stress responses in children.

Effects of Virtual Reality Content on Anxiety During Third Molar Surgery

This randomized controlled study evaluated whether the content of an immersive virtual reality environment influenced anxiety in adults undergoing surgical removal of an impacted mandibular third molar. A total of 75 patients aged 18-40 years with elevated dental anxiety were randomly assigned in a 1:1:1 ratio to a nature-based virtual reality group, an art-gallery virtual reality group, or a control group receiving conventional care without virtual reality. Participants in the two virtual reality groups wore the same headset and headphones and viewed standardized 360-degree content from the beginning of surgery until completion of the procedure. Anxiety was assessed using the Modified Dental Anxiety Scale, the State-Trait Anxiety Inventory-State subscale, and an 11-point numerical anxiety rating scale. Systolic and diastolic blood pressure, heart rate, and peripheral oxygen saturation were also recorded. Measurements were obtained before local anesthesia, after local anesthesia but before surgery and virtual reality exposure, and immediately after wound closure, as applicable. The study compared changes in anxiety and physiological measures among the three groups and examined whether nature-based and art-gallery virtual reality content produced different responses.

Turtle-Assisted Animal Interaction on Dental Anxiety and Physiological Parameters in Children

This study aims to measure the effect of a structured AAT session with a turtle present on dental anxiety and behavioral compliance in children during routine procedures that do not require local anesthesia in a pediatric dental clinic.

Acupressure and Hand Massage for Reducing Anxiety During Dental Local Anesthetic Injections in Children

This study aims to compare the effects of acupressure ,hand massage , and routine behavioral management on anxiety in children undergoing dental local anesthetic injections . Anxiety will be evaluated using Venham Picture Test ( VPT ) and heart rate measurements at specified time points before , during and after the injection procedure .

Clinical Study Evaluating the Effect of Virtual Reality on Reducing Patients' Anxiety During Wisdom Teeth Extraction

Dental anxiety is common during third molar extractions and may exacerbate pain perception. Local anesthesia does not prevent exposure to stress-inducing stimuli. Virtual reality (VR) combined with hypnotic scripts (HypnoVR®) provides immersive multisensory distraction. This study tests whether VR reduces perioperative anxiety and postoperative pain compared to local anesthesia alone.