Regenerative Gel (Emdogain®) for Healing After Wisdom Tooth Extraction | NCT07718932

NCT07718932

Overview

NCT ID: NCT07718932
Lead Sponsor: Aristotle University Of ThessalonikiOTHER
Official Title: The Role of Enamel Matrix Derivative in Reducing the Periodontal Defect Distal to the Mandibular Second Molar Following Surgical Extraction of the Third Molar
Brief 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.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 22, 2026Actual
Start Date: Mar 9, 2026Actual
Primary Completion Date: Sep 30, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 70Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: Ioulianos Dimitrios Apessos, DDS, MD, MScContact
idapessos@auth.gr

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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