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

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

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 Overview

• Status: Completed
• Conditions: Attachment Loss, Periodontal; Teeth, Impacted
• Intervention / Treatment: Drug: Amelogenin; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 27 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Amelogenin; amelogenins applied on the distal surface of the lower second molar after adjacent third molar extraction; Other Names: third molar surgery
Placebo Comparator: 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	Drug: Placebos; placebo applied on the distal surface of the lower second molar after adjacent third molar extraction; Other Names: third molar surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Principal Investigator: Roberto Pippi, MDDS, Sapienza University of Rome

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2016
• Primary Completion (Actual): April 20, 2018
• Study Completion (Actual): April 20, 2018

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: third molar surgery; amelogenin; periodontal pocket
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Periodontal Atrophy; Tooth, Impacted; Periodontal Attachment Loss
• Other Study ID Numbers: 3522/13.02.2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No