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

Study Overview
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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.

Official Title
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Usefulness of Amelogenins in the Treatment of Periodontal Defects on the Distal Surface of the Lower Second Molar After Adjacent Third Molar Extraction: a Pilot Study

Conditions
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Attachment Loss, Periodontal, Teeth, Impacted

Intervention / Treatment
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* Drug: Amelogenin
* Drug: Placebos


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 27 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, split-mouth, placebo-controlled, single blind clinical trial, a pilot study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: amelogenins group<br>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 | Drug: Amelogenin<br>* amelogenins applied on the distal surface of the lower second molar after adjacent third molar extraction<br>* Other names: third molar surgery;|
| Placebo Comparator: placebo group<br>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 | Drug: Placebos<br>* placebo applied on the distal surface of the lower second molar after adjacent third molar extraction<br>* Other names: third molar surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAL (Clinical attachment level) pre operative |  | baseline, pre-surgery | 
| CAL (Clinical attachment level) post operative |  | 7 days after surgery | 
| CAL (Clinical attachment level) 3 months |  | 3 months after surgery. | 
| CAL (Clinical attachment level) 12 months |  | 12 months after surgery. | 
| PPD (Periodontal probing dept) pre operative |  | baseline, pre-surgery | 
| PPD (Periodontal probing dept) post operative |  | 7 days after surgery | 
| PPD (Periodontal probing dept) 3 months |  | 3 months after surgery. | 
| PPD (Periodontal probing dept) 12 months |  | 12 months after surgery. | 
| REC (recession) pre operative |  | baseline, pre-surgery | 
| REC (recession) post operative |  | 7 days after surgery | 
| REC (recession) 3 months |  | 3 months after surgery. | 
| REC (recession) 12 months |  | 12 months after surgery. | 
| Radiographic bone Level pre operative |  | An endoral x-ray was taken baseline, pre-surgery | 
| Radiographic bone Level post operative |  | An endoral x-ray was taken 7 days after surgery | 
| Radiographic bone Level 3 months |  | An endoral x-ray was taken 3 months after surgery. | 
| Radiographic bone Level 12 months |  | An endoral x-ray was taken 12 months after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events pre operative | the occurrence of adverse events after the use of amelogenins. | pre-operative | 
| Adverse Events post operative | the occurrence of adverse events after the use of amelogenins. | 7 days after surgery | 
| Adverse Events 3 months | the occurrence of adverse events after the use of amelogenins. | 3 months after surgery. | 
| Adverse Events 12 months | the occurrence of adverse events after the use of amelogenins. | 12 months after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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third molar surgery, amelogenin, periodontal pocket