Regenerative Gel to Support Second Molar Health After Wisdom Tooth Extraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-center randomized trial evaluating whether placing Emdogain at the time of wisdom tooth extraction improves long-term periodontal health of the adjacent second molar. Eligible participants are healthy adults aged 18–45 with a horizontally or mesially impacted lower third molar that touches the second molar. The study uses standardized clinical measurements at multiple sites around the second molar to assess tissue outcomes and compares EMD treatment to standard care. Primary goal is to see if the site-specific intraoperative application reduces distal tissue defects after extraction. The trial aims to generate reproducible data through strict inclusion criteria and measurement protocols.

Why it matters

Who can join: the full rules

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) affecting the remaining dentition, excluding the localized defect associated with the impacted third molar.
* Presence of active acute infection (e.g., purulent pericoronitis) or radiolucent pathologic lesions extending beyond the normal follicular space (e.g., dentigerous cysts) that would significantly alter the baseline bony defect morphology.
* Known allergy or hypersensitivity to any of the medications utilized in the surgical or postoperative protocol (e.g., local anesthetics, prescribed antibiotics, or analgesics).
* Previous orthodontic treatment utilizing bands on the mandibular second molars that could have affected the periodontal attachment.

Where it's running

• 424 General Military Hospital
  Thessaloniki, Greece Recruiting
• Aristotle University of Thessaloniki
  Thessaloniki, Greece Recruiting

Study contacts

• Study coordinator: Ioulianos Dimitrios Apessos, DDS, MD, MSc
• Email: idapessos@auth.gr
• Phone: +306937098861

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.