Verify if Amelogenins Had Some Benefits in Improving Lower 2nd Molar Periodontal Healing After 3rd Molar Extraction

University of Roma La Sapienza

Status and phase: Completed; Phase 4

Conditions: Teeth, Impacted; Attachment Loss, Periodontal

Treatments: Drug: Amelogenin; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT04314726

3522/13.02.2015

Details and patient eligibility

About

Background: Prevention of periodontal defects after the extraction of lower third molars remains a challenge. Various methods have been proposed in the literature, but there are no studies which evaluated the effectiveness of amelogenins.

Methods: A single-blind split-mouth randomized controlled clinical trial (RCT) was performed on 5 patients to verify if amelogenins had some benefits in improving lower second molar periodontal healing after adjacent third molar extraction. A PPD ≥ 8 mm associated with a radiographic bone defect of at least 5 mm were the main inclusion criteria.

Enrollment: 5 patients

Sex: All

Ages: 18 to 27 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients aged < 27, for which the extraction of both lower third molars was indicated
• Bilateral total (bone or osteo-mucosal) third molar impaction
• Bilateral bone defect ≥ 5mm distal to the lower second molars, evaluated on pre- operative periapical radiographs performed with Rinn's film holders
• PPD ≥ 8mm distal to the second lower molars, in at least one of the following probing sites: buccal, disto-buccal, disto-central, disto-lingual
• Intra-operative integrity of both third molar buccal and lingual alveolar cortices

Exclusion criteria

• Smoking habit
• Systemic disorders with serious immunologic impairment
• Taking cortisone or other drugs that might interfere with healing process
• Allergy to penicillins
• Previous periodontal treatment
• Less than 2 mm of adherent gingiva at second molar level
• Second molars with a prosthetic crown
• Previous endodontic treatment of second molars
• Furcation involvement of the second molars

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5 participants in 2 patient groups, including a placebo group

amelogenins group

Active Comparator group

Description:

The study involved enrolling 5 periodontitis free patients, to which the extraction of both lower third molars was prescribed. A bone defect at the distal surface of the second molar ≥ 5 mm, had to be present on the intraoral periapical radiography, bilaterally. Amelogenins effect was evaluated by applying them only in the test site and comparing healing results with those obtained on the contra-lateral site

Treatment:

Drug: Amelogenin

placebo group

Placebo Comparator group

Description:

The study involved enrolling 5 periodontitis free patients, to which the extraction of both lower third molars was prescribed. A bone defect at the distal surface of the second molar ≥ 5 mm, had to be present on the intraoral periapical radiography, bilaterally. In this group (control site) the conventional treatment was performed, and healing was ensured only by the simple blood clot

Treatment:

Drug: Placebos