Regenerative Gel (Emdogain®) for Healing After Wisdom Tooth Extraction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorAristotle University Of Thessaloniki
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Enamel Matrix Derivative (Emdogain®)
Other interventionApplication 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: EmdogainExperimental treatment 1 intervention
Group B: Spontaneous HealingNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline (immediately prior to surgery) and 6 months post-surgerySecondary outcomes
1
Change in Radiographic Alveolar Bone Level
The vertical distance from the CEJ to the alveolar bone crest at the distal aspect of the mandibular second molar. Measurements will be conducted using standardized intraoral radiographs taken with the parallel cone technique and an individualized occlusal jig to ensure precise spatial reproducibility. The images will be calibrated using radiopaque spheres to account for magnification and will be evaluated by three independent, masked observers.
Time frame
Baseline (immediate post-operative) and 6 months post-surgery2
Change in Probing Pocket Depth (PPD)
Distance from the free gingival margin to the base of the periodontal pocket, measured in millimeters (mm) using a calibrated periodontal probe at the seven designated sites around the mandibular second molar (as defined in the primary outcome).
Time frame
Baseline (immediately prior to surgery) and 6 months post-surgery3
Change in Gingival Recession (REC)
Distance from the cementoenamel junction (CEJ) or fixed coronal reference point to the free gingival margin, measured in millimeters (mm) using a calibrated periodontal probe at the seven designated sites around the mandibular second molar.
Time frame
Baseline and 6 months post-surgery4
Change in Bleeding on Probing (BOP)
A dichotomous index (yes/no) assessing the presence or absence of bleeding after periodontal probing at the six sites around the mandibular second molar. It acts as a clinical indicator of localized tissue inflammation.
Time frame
Baseline and 6 months post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Aristotle University Of Thessaloniki
Lead sponsor
Institut Straumann AG
Collaborator
Source ClinicalTrials.gov