Clinical Research Directory

Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy

The rationale of this trial is to evaluate whether combining intranasal atomized midazolam with nitrous oxide offers better behavior management leading to successful treatment completion in comparison with using nitrous oxide alone. If this combination works well, it can establish a reliable, non-invasive protocol to treat highly anxious and uncooperative pediatric patients safely. Additionally, studying the mucosal atomization device will confirm if this mist-like delivery reduces the nasal irritation and discomfort common with traditional drops. If this combined strategy proves successful, it will provide pediatric dentists with a predictable, stress-free outpatient technique that improves patient comfort without risking safety. Beyond these clinical benefits, this trial introduces an innovative framework that aligns advanced pediatric behavior management with "Green Dentistry" principles

Evaluating Operation Calm With Children, Parents, and Clinicians

Operation Calm is a single-arm, mixed-methods feasibility study evaluating a virtual reality (VR) nature-based mindfulness intervention with children and adolescents aged 6-17 years, parents, and clinicians. Children complete one guided mindfulness session combining an immersive 360° nature environment with breathing, sensory awareness, and grounding exercises. Parents and clinicians view the intervention through a secure online link. The study examines feasibility, acceptability, engagement, usability, perceived usefulness, and child tolerability. It also explores immediate changes in children's anxiety, calmness, state mindfulness, and nature connectedness. Feedback from children, parents, and clinicians will guide further refinement of Operation Calm before it is evaluated in a larger clinical study.

Virtual Reality and Point-of-View Video Modeling for Dental Anxiety in Children

Dental anxiety is common among children and may make dental treatment more difficult. This study aims to compare three non-pharmacological behavior guidance techniques for reducing dental anxiety and improving cooperation during invasive fissure sealant treatment in children aged 6-10 years. Children who require an invasive fissure sealant on a mandibular first molar and meet the study eligibility criteria will be included. Participants will be randomly assigned to one of three groups. The first group will watch a 1.5-2-minute Point-of-View (POV) video showing the dental examination and treatment process from a child's perspective before the dental procedure. The second group will use virtual reality (VR) glasses during the procedure and watch age-appropriate animation or cartoon content as an active distraction technique. The control group will receive the standard Tell-Show-Do behavior guidance technique. Dental anxiety, behavior, physiological responses, and pain will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), Facial Image Scale (FIS), Frankl Behavior Rating Scale, pulse rate, oxygen saturation, and Wong-Baker FACES Pain Rating Scale. A post-intervention satisfaction and experience questionnaire will also be administered to assess the children's experiences with the behavior guidance techniques. The study is expected to provide comparative evidence regarding the effectiveness of POV video modeling and VR distraction compared with the standard Tell-Show-Do technique in managing dental anxiety and improving children's cooperation during dental treatment.

Aromatherapy vs Music Therapy for Anxiety in Children During Dental Radiography

This study aims to evaluate and compare the effects of aromatherapy and music therapy on anxiety levels in children undergoing intraoral radiographic examination for the first time. Dental anxiety is a common problem in pediatric patients and can negatively impact cooperation and treatment outcomes. Children included in the study will be randomly assigned to four groups: aromatherapy and music group, aromatherapy group, music therapy group, or control group. In the aromatherapy group, children will be exposed to a selected essential oil (lavender oil) before the radiographic procedure, while in the music therapy group, children will listen to calming music through a speaker. The group receiving both aromatherapy and music therapy will listen to music while being exposed to the essential oil. The control group will receive standard care without any additional intervention. Anxiety levels will be assessed before and after the radiographic procedure using the Facial Imaging Scale (FIS). Simultaneously, pulse rate will be measured before and after the procedure using a finger pulse oximeter. The primary aim is to determine whether aromatherapy, music therapy, or a combination of both is more effective in reducing anxiety compared to the control group. The findings of this study are expected to contribute to the development of simple, non-invasive, and cost-effective methods to improve the comfort and cooperation of pediatric patients during dental radiographic 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.

AI-Assisted Evaluation of Dental Anxiety in Children: A Machine Learning Approach

This observational study evaluated whether children's dental anxiety could be identified from their speech using artificial intelligence and machine learning methods. Children aged 8-12 years attending a pediatric dentistry clinic answered a set of short, standardized questions before receiving dental treatment. Their speech was recorded, and their dental anxiety was assessed during the same session using three established measures: the Children's Fear Survey Schedule-Dental Subscale, the Modified Child Dental Anxiety Scale, and the Face Image Scale. Acoustic characteristics of the children's voices and linguistic characteristics of their spoken responses were analyzed together. Four machine learning algorithms were developed and evaluated to determine how accurately they could distinguish between children with lower and higher levels of dental anxiety. No treatment was assigned or modified as part of the study.

Feasibility of a Modified Dental Comfort Position for Pediatric Patients Receiving Dental Exams

The goal of this study is to learn if a modified bottom-to-bottom comfort position is a feasible alternative to the traditional knee-to-knee position during dental hygiene examinations for patients aged 12 months to 5 years. In the modified position, the patient sits in their caregiver's lap and reclines their head on the dental chair, allowing for both parental contact and dental provider access to the patient's mouth. This study will also examine the modified position's impact on the patient's distress and cooperation during the exam, parental satisfaction, and provider perception. The main questions are: Is the modified comfort position a safe and feasible alternative for young children undergoing dental hygiene exams? How does the modified comfort position impact patient completion rate and dental exam duration? How does the modified comfort position impact patient distress and cooperation, parental satisfaction, and provider acceptability? Participants will: Utilize the modified comfort position with the guidance of a Certified Child Life Specialist. Undergo a routine dental hygiene exam. Answer survey questions about parental satisfaction and patient psychological and developmental diagnoses. Dental providers will answer survey questions about acceptability and feasibility.

Immersive Virtual Reality for Pain and Dental Anxiety During Pediatric Restorative Treatment

This study evaluated whether immersive virtual reality (VR) can help reduce pain and dental fear and improve behavioral cooperation in children undergoing restorative dental treatment. Children aged 8-12 years who required treatment of primary molars were randomly assigned to either a VR group or a control group. Children in the VR group watched an age-appropriate animated video through a VR headset during local anesthesia and dental treatment, while children in the control group received routine dental treatment without VR. Pain, dental anxiety, dental fear, behavioral cooperation, emotional responses, physiological measurements, treatment duration, and parent and clinician satisfaction were assessed and compared between the two groups.

AI-Generated Personalized Story Book to Improve Patient Behaviour

Dental anxiety and uncooperative behavior frequently interfere with the successful delivery of dental treatment in children and may increase the need for pharmacological behavior management. Storytelling is a widely used non-pharmacological behavior guidance technique that can improve participants' familiarity with the dental environment and enhance cooperation. Recent advances in artificial intelligence (AI) enable the development of personalized storybooks tailored to each participant's individual characteristics and preferences, which may improve engagement with behavior guidance interventions. This randomized controlled trial aims to compare the effectiveness of three behavior guidance approaches in pediatric participants receiving dental treatment: (1) an AI-generated personalized dental storybook, (2) a standard dental storybook, and (3) standard behavior guidance alone. Eligible participants will be randomly allocated to one of the three study groups. The AI-generated storybook will be individually designed according to each participant's characteristics and interests, whereas the standard storybook will contain the same dental theme without personalization. Participants in the control group will receive routine non-pharmacological behavior guidance used in pediatric dental practice. Behavioral cooperation, dental anxiety, treatment acceptance, and other prespecified outcomes will be assessed using validated measurement tools before and during dental treatment.

Effectiveness of Puppet Modeling During Dental Emergency Visits on Dental Anxiety and Behavior of Children in a Subsequent Visit

The goal of this clinical trial is to learn if using a puppet in dental visits for children is an effective behavior guidance tool. The main questions it aims to answer are: * Does using a puppet to explain dental procedures to children during emergency dental visits lower their anxiety in a subsequent dental visit? * Does using a puppet to explain dental procedures to children during emergency dental visits improve their behavior in a subsequent dental visit? Researchers compared the effect of using a puppet to the traditional tell-show-do behavior guidance technique to see if the puppet is more effective in lowering their anxiety and improving their behavior. Participants were randomly allocated into two groups: * Group I: Children who received puppet play therapy in the emergency dental visit and in the subsequent dental visit. * Group II: Children who received only the traditional tell-show-do behavior guidance technique in the emergency dental visit and in the subsequent dental visit.

Tactile Pre-Visit Imagery

In pediatric dentistry, our primary goals are to prevent dental caries and, when necessary, provide treatment in a safe and comforting environment that minimizes anxiety for young patients. By familiarizing young patients with the steps involved in common dental procedures, tactile pre-visit imagery booklets can reduce the fear of the unknown. Study Objective/Purpose: The purpose of this study is to determine whether tactile pre-visit imagery could reduce dental anxiety and fear in pediatric patients prior to their first restorative procedure. An additional aspect of this study entails assessing the patient's behavior and determining if it improves with the use of a tactile pre-visit imagery booklet.

Dental Play Intervention Before Restorative Care in Children

This pilot study designed to evaluate the feasibility and potential impact of play-based interventions on pediatric dental patients. The intervention consists of a structured dental play session prior to restorative treatment, aimed at reducing anxiety and improving behavioral cooperation. Data will be collected during and after the procedure, focusing on observed behavior and responses to standardized assessments.

Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction

The goal of this clinical trial is to learn if virtual reality distraction can reduce dental anxiety and pain perception in children aged 6-10 years undergoing simple dental extraction. The main questions it aims to answer are: Does virtual reality distraction lower dental anxiety compared to audio-visual distraction and conventional tell-show-do techniques? Does virtual reality distraction reduce pain perception during dental extraction? Researchers will compare virtual reality distraction, audio-visual distraction (2D cartoons with headset), and conventional tell-show-do with verbal distraction to see which method is most effective in improving child cooperation and reducing anxiety and pain. Participants will: Wear VR glasses to watch immersive 3D cartoons, or Watch 2D cartoons with headset, or Receive the conventional tell-show-do technique with verbal distraction. Outcome measures will include child dental anxiety (CFSS-DS, VCARS), pain perception (Wong-Baker FACES), physiological parameters (pulse rate, SpO₂), and behavioral cooperation (Frankl scale).

Virtual Reality for Pain and Anxiety in Pediatric Dental Treatment

The goal of this clinical trial is to learn whether immersive virtual reality (VR) reduces pain and anxiety in children aged 6-12 years during routine dental procedures. The main questions it aims to answer are: * Does VR distraction reduce self-reported pain and anxiety during dental treatment compared to standard behaviour guidance? * Does VR distraction improve children's post-procedural experience and willingness to return for future dental visits? Researchers will compare children using a VR headset during dental treatment to children receiving standard behaviour guidance techniques. Participants will: * Attend one routine dental appointment * Be randomly assigned to wear a VR headset or receive standard care during their procedure * Complete brief questionnaires about pain and anxiety before and after treatment * Receive a follow-up phone call 24-72 hours after the appointment

The Effect of Teledentistry on Dental Anxiety in Children: A Randomized Clinical Trial

This randomized controlled trial aimed to evaluate the effect of a brief teledentistry consultation on dental anxiety in children aged 7-11 years. Two hundred children with no previous dental visits or treatment experience were randomly assigned to either a teledentistry group or a conventional clinical examination group. The teledentistry group received a standardized 3-5-minute pre-appointment video consultation via WhatsApp before their first dental visit. Dental anxiety was assessed using subjective and physiological parameters before and after the examination. The study investigated whether teledentistry could reduce dental anxiety and improve children's adaptation to their first dental visit.

Kaleidoscope Compared to Tell-Show-Do for Reducing Children Pain and Anxiety During Pulp Therapy

The goal of this clinical trial is to investigate if Kaleidoscope glasses help children feel less pain and worry during dental work. It will also explore if these glasses help children feel more comfortable with the dentist. Kaleidoscope glasses are special glasses show bright, colorful shapes. The patterns change every time the child moves their head. This helps keep the child's mind off the dental work. The main questions it aims to answer are: Do the glasses lower a child's pain during a numbing shot and tooth treatment? Do the glasses help a child feel less anxious during the visit? Researchers will compare the glasses to a method called "Tell-Show-Do" to see which works best. "Tell-Show-Do" is when a dentist explains and shows tools before using them. Participants will: Get a nerve treatment (a "baby root canal") on a bottom baby tooth. Wear the Kaleidoscope glasses, have the researcher use "Tell-Show-Do," or do both. Have their pulse and pain levels checked before, during, and after the visit. To keep the study fair, the child will be put into 1 of 3 groups by picking a sealed random envelope. The groups are: Group 1: The child wears Kaleidoscope glasses (the special glasses). Group 2: The child wears Kaleidoscope glasses and the operator uses the "Tell-Show-Do" method during the visit with the child. Group 3: The operator uses the "Tell-Show-Do" method during the visit with the child only. This study helps make the dental visit easier and more comfortable for children. It aims to: Lower pain during the tooth treatment. Help children feel less afraid of the dentist. Make children more willing to get the care they need. The research also helps dentists give better care by building trust with their young participants. Risks: There are no serious risks in this study. In rare cases, a child may not want to wear the special glasses. If this happens, the researcher will stop using the glasses but will still finish the tooth treatment.

Effect of Regular Piano Playing on Dental Anxiety and Stress

This study aims to evaluate dental anxiety and stress levels in children receiving regular piano training compared with children without piano training during preventive dental treatment. A total of 80 children aged 7-11 years, including 40 children receiving piano education and 40 controls, were included in the study. All participants underwent fissure sealant application using the Tell-Show-Do behavioral guidance technique. Dental anxiety was assessed before and after treatment using the Modified Child Dental Anxiety Scale-Faces Version (MCDASf), Facial Image Scale (FIS), and physiological parameters including pulse rate, blood pressure, oxygen saturation, and body temperature. Stress levels were evaluated using the PeSSKi scale. The study investigates whether regular piano education contributes to reduced dental anxiety and stress responses in pediatric dental patients.

Effect of a Visual Educational Intervention on Dental Anxiety in Children

This study evaluated whether a visual educational intervention could reduce dental anxiety in children. During the COVID-19 pandemic, changes in the dental environment, including the use of personal protective equipment, may have increased anxiety levels in pediatric patients. A total of 70 children aged 5 to 14 years were randomly assigned to either a study group that received a visual educational introduction to the dental environment or a control group that received standard care. Dental anxiety was assessed using validated scales and pulse rate measurements. The results showed that children who received the visual educational intervention had lower anxiety levels and reduced physiological stress compared to the control group. The effect was more pronounced in older children, suggesting that age and cognitive development play an important role in the effectiveness of such interventions. Overall, this simple and non-invasive approach may help reduce dental anxiety in children and improve their experience during dental visits.