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

NCT07718932 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-07-22

No results posted yet for this study

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

Interventions

OTHER

Enamel Matrix Derivative (Emdogain®)

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.

Sponsors & Collaborators

  • Institut Straumann AG

    collaborator INDUSTRY

  • Aristotle University Of Thessaloniki

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2027-09-30
Completion
2027-10-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07718932 on ClinicalTrials.gov