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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-24

Study Completion Date

2018-04-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Attachment Loss, Periodontal Teeth, Impacted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, split-mouth, placebo-controlled, single blind clinical trial, a pilot study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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amelogenins group

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

Group Type ACTIVE_COMPARATOR

Amelogenin

Intervention Type DRUG

amelogenins applied on the distal surface of the lower second molar after adjacent third molar extraction

placebo group

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

placebo applied on the distal surface of the lower second molar after adjacent third molar extraction

Interventions

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Amelogenin

amelogenins applied on the distal surface of the lower second molar after adjacent third molar extraction

Intervention Type DRUG

Placebos

placebo applied on the distal surface of the lower second molar after adjacent third molar extraction

Intervention Type DRUG

Other Intervention Names

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third molar surgery third molar surgery

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

27 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes