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

NCT04314726 | Completed Phase 4 DMC

• 1 other identifier: 3522/13.02.2015
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Attachment Loss, Periodontal; Teeth, Impacted

Keywords

third molar surgery; amelogenin; periodontal pocket

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (4)

• Adverse Events pre operative

  pre-operative

• Adverse Events post operative

  7 days after surgery

• Adverse Events 3 months

  3 months after surgery.

• Adverse Events 12 months

  12 months after surgery.

Study Arms (2)

amelogenins group

ACTIVE COMPARATOR

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

placebo group

PLACEBO COMPARATOR

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

Interventions

Amelogenin DRUG

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

Also known as: third molar surgery

amelogenins group

Placebos DRUG

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

Also known as: third molar surgery

placebo group

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Periodontal Attachment Loss; Tooth, Impacted; Periodontal Pocket

Interventions

Amelogenin

Condition Hierarchy (Ancestors)

Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Dental Enamel Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Roberto Pippi, MDDS

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MDDS, associate Professor

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

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 19, 2020
• Study Start: March 24, 2016
• Primary Completion: April 20, 2018
• Study Completion: April 20, 2018
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share