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

University of Roma La Sapienza5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Attachment Loss, Periodontal Teeth, Impacted

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 27 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

CAL (Clinical attachment level) pre operative

Time frame: baseline, pre-surgery

CAL (Clinical attachment level) post operative

Time frame: 7 days after surgery

CAL (Clinical attachment level) 3 months

Time frame: 3 months after surgery.

CAL (Clinical attachment level) 12 months

Time frame: 12 months after surgery.

PPD (Periodontal probing dept) pre operative

Time frame: baseline, pre-surgery

PPD (Periodontal probing dept) post operative

Time frame: 7 days after surgery

PPD (Periodontal probing dept) 3 months

Time frame: 3 months after surgery.

PPD (Periodontal probing dept) 12 months

Time frame: 12 months after surgery.

REC (recession) pre operative

Time frame: baseline, pre-surgery

REC (recession) post operative

Time frame: 7 days after surgery

REC (recession) 3 months

Time frame: 3 months after surgery.

REC (recession) 12 months

Time frame: 12 months after surgery.

Radiographic bone Level pre operative

Time frame: An endoral x-ray was taken baseline, pre-surgery

Radiographic bone Level post operative

Time frame: An endoral x-ray was taken 7 days after surgery

Radiographic bone Level 3 months

Time frame: An endoral x-ray was taken 3 months after surgery.

Radiographic bone Level 12 months

Time frame: An endoral x-ray was taken 12 months after surgery.

Secondary Outcomes

Adverse Events pre operative

the occurrence of adverse events after the use of amelogenins.

Time frame: pre-operative

Adverse Events post operative

the occurrence of adverse events after the use of amelogenins.

Time frame: 7 days after surgery

Adverse Events 3 months

the occurrence of adverse events after the use of amelogenins.

Time frame: 3 months after surgery.

Adverse Events 12 months

the occurrence of adverse events after the use of amelogenins.

Time frame: 12 months after surgery.