Regenerative Gel (Emdogain®) for Healing After Wisdom Tooth Extraction (NCT07718932) | Clinical Trial Compass
RecruitingNot Applicable
Regenerative Gel (Emdogain®) for Healing After Wisdom Tooth Extraction
Greece70 participantsStarted 2026-03-09
Plain-language summary
This study investigates whether the intraoperative application of a specialized regenerative gel (Emdogain®) can improve the periodontal health of the mandibular second molar by preventing or reducing the formation of tissue defects after the surgical removal of an adjacent impacted lower wisdom tooth.
Surgical extraction of a lower wisdom tooth frequently leaves a deep pocket or a permanent hard and/or soft tissue defect on the back side of the neighboring second molar. This defect compromise the surrounding tissues and predispose the healthy second molar to future complications like root caries, dentin hypersensitivity, or localized gum disease. While most existing treatments address these defects after they have formed, this trial evaluates a site-specific preventive approach during the extraction process itself.
The study will involve 70 systemically healthy adults (ages 18-45) requiring surgical removal of a horizontally or mesially oriented impacted lower third molar. Participants will be randomized into two equal groups:
The Test Group: Will receive root conditioning with PrefGel and a single application of Emdogain® gel directly to the root surface and socket immediately after tooth removal.
The Control Group: Will undergo identical surgery but will follow a natural, spontaneous healing process without the application of any biomaterials.
The main objective is to measure changes in Clinical Attachment Level (CAL) at the distal aspects of the second molar using stable vertical anatomical reference points over a 6-month period. The trial will also monitor secondary healing parameters, including probing pocket depths, gum recession, radiographic bone level changes using standardized jigs, postoperative pain, swelling, and early tissue healing dynamics.
Who can participate
Age range
18 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy adult patients aged 18 to 35 years old (ASA I or II).
* Presence of an asymptomatic, partially or fully impacted mandibular third molar requiring surgical extraction.
* The third molar impaction must be mesioangular or horizontal, with its crown in direct physical contact with the adjacent second molar, as assessed by a preoperative panoramic radiograph.
* The adjacent mandibular second molar must be vital, fully erupted, and structurally sound (free of extensive dental caries or prosthetic crowns).
* Patients must demonstrate an adequate level of overall oral hygiene and gingival health (e.g., Full-Mouth Plaque Index \< 20% and Full-Mouth Bleeding Score \< 20% following initial prophylaxis and oral hygiene instructions).
* Willingness to comply with postoperative instructions and adhere to the scheduled follow-up visits.
* Ability to understand the study procedures and voluntarily sign the informed consent form.
Exclusion Criteria
* Presence of systemic diseases or conditions that could compromise wound healing or periodontal health (e.g., uncontrolled diabetes mellitus, autoimmune disorders).
* Current or recent use of medications known to affect bone metabolism or wound healing (e.g., bisphosphonates, long-term systemic corticosteroids, immunosuppressants).
* History of heavy smoking (e.g., \>10 cigarettes per day) or use of smokeless tobacco products.
* Pregnant or lactating females.
* Diagnosis of periodontitis (Stage II, III, or IV) affe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Clinical Attachment Level (CAL)
Timeframe: Baseline (immediately prior to surgery) and 6 months post-surgery