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

NCT07718932 | Recruiting

• 1 other identifier: 316/18.12.2025.
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Alveolar Bone Loss; Periodontal Pocket; Impacted Tooth With Abnormal Positioning

Keywords

Enamel Matrix Derivative; Emdogain; Third Molar Surgery; Periodontal Defect; Osseous Defect; Clinical Attachment Level; Probing Pocket Depth; Periodontal Regeneration; Mandibular Second Molar; Prophylactic Periodontal Treatment

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Attachment Level (CAL)

  Clinical Attachment Level (CAL) is a measurement of periodontal health indicating the position of the soft tissue attachment on the tooth root, measured in millimeters (mm) using a calibrated periodontal probe. It will be recorded at seven distinct sites on the mandibular second molar. For the distal sites directly adjacent to the extraction socket, fixed coronal reference points will be used to calculate relative CAL, as the cementoenamel junction (CEJ) is often compromised by the impaction. For the remaining four sites on the second molar, the standard CEJ will be utilized as the fixed anatomical reference point. A reduction in the distance from these reference points to the base of the periodontal pocket over time indicates a clinical gain of tissue attachment and successful healing.

  Baseline (immediately prior to surgery) and 6 months post-surgery

Secondary Outcomes (10)

• Change in Radiographic Alveolar Bone Level

  Baseline (immediate post-operative) and 6 months post-surgery

• Change in Probing Pocket Depth (PPD)

  Baseline (immediately prior to surgery) and 6 months post-surgery

• Change in Gingival Recession (REC)

  Baseline and 6 months post-surgery

• Change in Bleeding on Probing (BOP)

  Baseline and 6 months post-surgery

• Change in Plaque Index (PI)

  Baseline and 6 months post-surgery

Study Arms (2)

Emdogain

EXPERIMENTAL

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.

Other: Enamel Matrix Derivative (Emdogain®)

Spontaneous Healing

NO INTERVENTION

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.

Interventions

Enamel Matrix Derivative (Emdogain®) OTHER

Application of 24% EDTA root conditioning gel (PrefGel) followed by the application of porcine-derived enamel matrix proteins (Emdogain®) to the distal root surface of the mandibular second molar prior to wound closure.

Also known as: Enamel Matrix Proteins, Amelogenin, Straumann Emdogain, EMD

Emdogain

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Institut Straumann AG: collaborator

Study Sites (2)

424 General Military Hospital

Thessaloniki, Greece

RECRUITING

Aristotle University of Thessaloniki

Thessaloniki, Greece

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss; Periodontal Pocket

Interventions

enamel matrix proteins; Amelogenin

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Dental Enamel Proteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Ioulianos Dimitrios Apessos, DDS, MD, MSc

CONTACT

+306937098861; idapessos@auth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are masked to their group allocation; they are informed during the consent process that they have a 50% chance of receiving the biomaterial, but they are not told their actual assignment during or after the surgery. The primary investigator/surgeon cannot be masked and will perform the clinical periodontal probing. However, to minimize bias, masking is applied to the Outcomes Assessors evaluating the secondary data: three independent observers, who are completely blinded to the patients' group allocations, will evaluate all standardized radiographs and clinical photographs to determine hard and soft tissue outcomes.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist - Oral Surgeon DDS, MD, MSc (Sleep Medicine), MSc (Oral Surgery), PhD candidate

Model Details: This is a two-arm, parallel-group, randomized controlled clinical trial. Eligible participants scheduled for the surgical extraction of an impacted mandibular third molar are randomly assigned in a 1:1 allocation ratio to either the Test Arm (extraction followed by root conditioning with PrefGel and the application of Emdogain®) or the Control Arm (extraction allowing for spontaneous natural blood clot healing). Both groups are followed simultaneously in parallel pathways and are evaluated at identical postoperative intervals for a total duration of 6 months.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

GR (2)