Clinical Research Directory

Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial

This multicenter randomized trial compares the clinical effectiveness of intraligamentary injection versus inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis in mandibular molars. The goal is to determine which technique provides better pain control during endodontic treatment.

A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction

The primary objective of this trial is to assess the safety and tolerability of single, ascending doses of CYT-1010 in healthy male and female volunteers and in the treatment of acute postoperative pain after third molar extraction.

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.

A Randomized Controlled Trial Evaluating Whether Pre-operative Trinase Reduces Post-operative Pain in Patients With Symptomatic Irreversible Pulpitis Compared to Placebo, Using VAS Scores and Analgesic Intake Over 48 Hours.

This study aims to determine whether Trinase, an enzyme-based anti-inflammatory medication, can reduce pain after root canal treatment in patients with symptomatic irreversible pulpitis. A total of 400 male patients aged 18 to 50 years who present with moderate to severe tooth pain were randomly assigned to receive either a Trinase tablet or a placebo 30 minutes before treatment. All root canal procedures were performed in a single visit using standard endodontic techniques. Pain levels were measured on a Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, and 48 hours after treatment. Patients recorded the number of pain-relief tablets they take during the first 48 hours. The goal of the study is to see whether Trinase can lower post-operative pain and reduce the need for analgesic medication compared with placebo. This information may help improve pain management for patients undergoing root canal therapy.

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.

Photobiomodulation and Tooth Analgesia

The purpose of this study is to test photobiomodulation (PBM) with a non-invasive light device for reducing discomfort during dental treatments in children. We plan to conduct a series of three clinical studies in 200 school-aged children requiring routine dental treatment. The first study aims to test if PBM works for tooth and soft tissue by assessing response to cold testing and probing of gums. The second study aims to test if use of PBM on soft tissues before injection reduces discomfort. The third study aims to test if PBM can be used to do simple dental fillings in baby teeth without numbing injection.

Patient Education and AI-Assisted Complaint Summaries in Endodontic Patients

The goal of this randomized clinical trial is to compare the same-day effects of three standardized patient education methods in adults presenting to an endodontic clinic with toothache. The main questions it aims to answer are: * Does standardized verbal education improve patients' knowledge, reduce antibiotic-related misconceptions, and reduce anxiety? * Does leaflet-based education produce comparable changes in knowledge, antibiotic-related misconceptions, and anxiety? * Does video-based education produce comparable changes in knowledge, antibiotic-related misconceptions, and anxiety? * Does teach-back performance differ according to the method used to deliver patient education? * Can an AI-assisted three-sentence complaint summary be generated reliably and used as a feasible clinician-facing communication support tool? Participants will be randomly assigned to one of three patient education groups. In the verbal education group, participants will receive a standardized 90-second verbal explanation covering warning signs, appropriate home-care measures, avoidance of potentially harmful practices, and appropriate antibiotic use. In the leaflet-based education group, participants will review a written leaflet containing the same core educational messages for 90 seconds. In the video-based education group, participants will watch a short video presenting the same core educational messages for 90 seconds. Knowledge level, antibiotic-related misconceptions, and anxiety will be assessed immediately before and immediately after the educational intervention. After education, participants will also be asked to restate the main messages in their own words using a teach-back procedure. In addition, symptom information collected using standardized prompts will be entered into an artificial intelligence tool to generate a concise three-sentence complaint summary. The feasibility, completeness, and clinician-rated usefulness of these summaries will be evaluated as process outcomes. AI-generated summaries will not be used for diagnosis, triage, or treatment decisions.

Local Dexamethasone Administration in Symptomatic Irreversible Pulpitis

Symptomatic irreversible pulpitis is associated with a high incidence of inadequate pulpal anesthesia during endodontic treatment, particularly in mandibular molar teeth. Failure to achieve profound anesthesia may result in increased intraoperative pain and patient discomfort. Corticosteroids have been suggested as adjunctive agents to improve pain control and reduce inflammatory responses; however, the influence of different local administration techniques on anesthetic success and postoperative pain remains unclear. The aim of this randomized controlled clinical trial is to compare the effects of submucosal and intraligamentary dexamethasone administration on anesthetic success and pain control in patients with symptomatic irreversible pulpitis. A total of 84 participants requiring root canal treatment of mandibular first or second molars diagnosed with symptomatic irreversible pulpitis will be randomly allocated to one of three groups: (1) inferior alveolar nerve block (IANB) followed by submucosal saline injection (control group), (2) IANB followed by submucosal dexamethasone injection, and (3) IANB followed by intraligamentary dexamethasone injection. All participants will receive standardized endodontic treatment under local anesthesia. The primary outcome measure is anesthetic success during access cavity preparation and pulp extirpation. Secondary outcome measures include postoperative pain intensity at 6, 12, 24, 48, and 72 hours, and postoperative analgesic consumption. The results of this study may provide evidence regarding the effectiveness of different local dexamethasone administration techniques and contribute to improved pain management strategies in endodontic practice.

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.

Comparing Obturation Using Bioceramic Nano-coated Gutta-percha With Bioceramic Sealer Versus Traditional Gutta-percha With Resin Sealer for Reducing Postoperative Pain and Swelling After Root Canal Treatment in Necrotic Single-rooted Teeth.

A randomized clinical trial will compare two root canal filling approaches in necrotic single-rooted teeth. The test group will receive bioceramic mono-block obturation using bioceramic nano-coated gutta-percha with a bioceramic sealer, while the control group will receive traditional gutta-percha with a resin-based sealer. The main aim is to determine whether the bioceramic system can reduce postoperative pain and swelling within 48 hours after treatment compared with the conventional method. Patients aged 20-55 years who have necrotic single-rooted teeth and meet specific clinical and radiographic criteria will be recruited from the outpatient clinics of the Faculty of Dentistry, Cairo University. Postoperative pain will be measured using a visual analogue scale, and swelling will be assessed using a standardized swelling score at 24 and 48 hours. The study hypothesizes that the bioceramic mono-block technique, due to its improved sealing ability and bioactivity, may lead to less postoperative discomfort and better early clinical outcomes than the gold-standard resin-sealer technique. The findings are expected to provide evidence to guide clinicians on whether adopting bioceramic nano-enhanced obturation can improve patient-centered outcomes after root canal treatment.

Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia

This randomized split-mouth clinical trial evaluated the efficacy of the Comfort-in needle-free injection system compared with conventional dental injection for local anesthesia during pulpotomy treatment in children. Sixty children aged 5 to 8 years who required bilateral pulpotomy of primary first molars were included. Each participant received both anesthesia techniques in separate treatment sessions with an interval of at least one week. The order of anesthesia techniques was randomized: 30 children received conventional dental injection in the first session and Comfort-in needle-free injection in the second session, while the remaining 30 children received the interventions in the reverse order. Pain perception during anesthesia administration and pulpotomy was assessed using the Face, Legs, Activity, Cry, Consolability scale and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including blood pressure, pulse, and oxygen saturation, were recorded before anesthesia, after anesthesia, and after pulpotomy. The amount of anesthetic solution used, duration of anesthetic effect, postoperative complications, and patient preference were also recorded. The study was designed to determine whether the Comfort-in needle-free injection system could provide effective local anesthesia for pediatric pulpotomy while reducing injection-related pain, physiological stress responses, anesthetic volume, duration of postoperative numbness, and postoperative complications compared with conventional dental injection.

Evaluation of the Sedative Effect of Contextualized Music Listening on Patient Pain and Anxiety in a Dental Care Setting

The goal of this clinical study is to determine whether listening to culturally and personally contextualized music can reduce pain and anxiety in adults undergoing dental procedures. It will also examine how this intervention affects physiological responses related to stress. The main questions it aims to answer are: * Does listening to a preselected, patient-chosen musical sequence reduce perceived pain during a dental procedure? * Does the music modulate physiological stress responses, such as heart rate and blood pressure? * Do the analgesic and anxiolytic effects vary depending on the patient's cultural musical preferences (e.g., Mashriq vs. Western music)? How do patients perceive the effectiveness of the music, and how does this relate to physiological and self-reported measures? Researchers will compare periods with and without music during the same dental procedure to evaluate the effect of the musical intervention. Participants will: * Choose a musical sequence from a predefined selection based on relaxing musical characteristics * Undergo a dental treatment involving drilling for caries * Experience alternating phases with and without music during the procedure * Have their heart rate, blood pressure, and pain levels measured at different stages * Complete questionnaires assessing anxiety before the procedure and their experience after the treatment The study includes 30 adult participants and is conducted in a private dental clinic.

Identification of Possible Trigeminal Neuralgia

Trigeminal neuralgia (TN) is a severe type of non-dental orofacial pain that can feel like sudden electric shocks in the face and is often mistaken for tooth pain or other dental problems. This can lead to delays in referral and unnecessary, sometimes irreversible, dental treatment. The goal of this observational study is to evaluate how well a new questionnaire (IDentification of possible Trigeminal Neuralgia - IDTN) identifies adults with possible trigeminal neuralgia among patients attending hospital clinics with orofacial pain, with the aim of supporting its use in dental and general medical practice to improve early recognition and referral. The main questions it aims to answer are: * How accurately does the IDTN questionnaire identify patients with possible trigeminal neuralgia compared with the specialist clinical diagnosis? * Which combination of questionnaire items best supports a practical screening score for use in dental and/or general medical practice? Participants will: 1. Complete the IDTN questionnaire before their clinical appointment (either electronically or on paper) 2. Undergo their usual specialist clinical assessment, during which the final diagnosis will be recorded 3. Allow the research team to compare questionnaire responses with the specialist diagnosis (the reference standard) A subset of participants will also be asked to complete the questionnaire again a few days later to assess test-retest reliability.

Effect of Play Dough, Slime, and Plush Toys on Dental Anxiety and Pain in Children During Dental Treatment

This study aims to evaluate the effectiveness of tactile distraction materials, including play dough, slime, and plush toys, on dental anxiety, pain perception, and physiological stress responses in children undergoing dental treatment. Ninety children aged 6-10 years receiving restorative dental treatment under local anesthesia were randomly assigned to one of four groups: play dough, slime, plush toy, or control group without distraction. Dental anxiety and pain levels were assessed using validated psychometric scales, while physiological stress responses were evaluated through heart rate monitoring and salivary cortisol measurements. The study seeks to determine whether simple non-pharmacological distraction techniques can improve behavioral cooperation and reduce anxiety and pain perception during pediatric dental procedures. Findings may contribute to the development of child-friendly dental management strategies and enhance the quality of pediatric dental care.

Anesthetic Effectiveness of Lidocaine Versus Articaine in Dentistry

Context: Lidocaine and articaine are two of the most commonly used local anesthetics in dentistry. Lidocaine has often been the anesthetic of choice in clinical practice, but in clinical experience, articaine has proven to be more effective in controlling pain during dental procedures. (Camps-Font, O. et al. 2020). There are still unanswered questions, such as which of the two local anesthetics is more effective in reducing pain? This could lead us to discuss which one to choose to reduce costs in the dental office. Objective: The objective of this project is to determine and compare the effectiveness of lidocaine and articaine in clinical contexts such as tooth extraction with infiltrative techniques, seeking to provide answers that will optimize the choice of anesthetic based on the patient and the procedure, thus improving pain management and reducing costs in the dental office. Design: Randomized double-blind experimental study, parallel groups. The control group received 2% lidocaine, and the experimental group received 4% articaine. The study will be conducted in accordance with the guidelines of the Consolidated Standards of Reporting Trials (CONSORT 2010). The probabilistic sampling technique is through simple randomization. The 100 patients who meet the inclusion criteria will be randomly assigned to the control and experimental groups in a 1:1 ratio. Expected results: articaine shows a lower percentage of extractions with anesthetic reinforcement and, therefore, a lower average number of additional tubes.

A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults

Dental pain, a common issue in stomatology, requires a multifaceted treatment approach. This study explores the efficacy of combining Ibuprofen with curcumin and liquorice root supplements for managing postoperative dental pain. Curcumin, known for its antioxidant and anti-inflammatory properties, along with liquorice root, may enhance pain relief beyond conventional NSAIDs like Ibuprofen. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of this combination therapy in adults undergoing the removal of impacted third molars. Participants, aged 18-85, were divided into groups receiving different doses of Ibuprofen and curcumin with liquorice root, compared to a control group receiving Ibuprofen and placebo. The primary outcome is the sum of pain intensity differences over 8 hours, with secondary outcomes including total pain relief and the occurrence of any adverse events. The anticipated sample size, considering a 20% dropout rate, is 264 participants, ensuring the study is powered to detect significant differences in pain management efficacy.

Dental Block for Pain Relief in ED Dental Pain Patients

This will be a prospective, observational cohort study assessing immediate pain relief from dental block in ED patients presenting with dental pain. The study will be conducted in the Community Regional Medical Center ED. The aim of this study, then, is to prospectively determine if dental block provides minimal clinically important difference in pain relief to these patients.

Meloxicam Versus Ibuprofen for Pain Control After Third Molar Exodontia in Adult Patients

Third molar extraction is a common dental procedure, offently related with pain and swelling. The purpose of this study is to evaluate if Meloxicam has a better effect relieving pain after the extraction than Ibuprofen, one of the most common pain relieving drugs administered after this procedure.