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The Role of Enamel Matrix Derivative in Reducing the Periodontal Defect Distal to the Mandibular Second Molar Following Surgical Extraction of the Third Molar

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Greece
424 General Military Hospital
RECRUITING
Thessaloniki
Aristotle University of Thessaloniki
RECRUITING
Thessaloniki
Contact Information
Primary
Ioulianos Dimitrios Apessos, DDS, MD, MSc
idapessos@auth.gr
+306937098861
Time Frame
Start Date: 2026-03-09
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 70
Treatments
Experimental: Emdogain
Participants in this arm will undergo standardized surgical extraction of the impacted mandibular third molar. Following extraction and thorough debridement of the defect, the exposed distal root surface of the adjacent second molar will be conditioned with 24% EDTA (PrefGel). After rinsing, Enamel Matrix Derivative (Emdogain®) will be applied directly to the site prior to standard suturing and primary closure.
No_intervention: Spontaneous Healing
Participants in this arm will undergo the identical standardized surgical extraction of the impacted mandibular third molar and thorough debridement of the defect. No root conditioning agents or regenerative biomaterials will be applied. The extraction socket and distal defect will be allowed to heal spontaneously via natural blood clot formation prior to standard suturing and primary closure.
Related Therapeutic Areas
Sponsors
Leads: Aristotle University Of Thessaloniki
Collaborators: Institut Straumann AG

This content was sourced from clinicaltrials.gov