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

Teeth, Impacted Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314726
• Other study ID #: 3522/13.02.2015
• Status: Completed
• Phase: Phase 4
• Start date: March 24, 2016
• Est. completion date: April 20, 2018

Study information

• Verified date: March 2020
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 20, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 27 Years

Eligibility

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

Related Conditions & MeSH terms

• Attachment Loss, Periodontal
• Periodontal Attachment Loss
• Teeth, Impacted
• Tooth, Impacted

Intervention

Drug:
• Amelogenin
amelogenins applied on the distal surface of the lower second molar after adjacent third molar extraction
• Placebos
placebo applied on the distal surface of the lower second molar after adjacent third molar extraction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAL (Clinical attachment level) pre operative		baseline, pre-surgery
Primary	CAL (Clinical attachment level) post operative		7 days after surgery
Primary	CAL (Clinical attachment level) 3 months		3 months after surgery.
Primary	CAL (Clinical attachment level) 12 months		12 months after surgery.
Primary	PPD (Periodontal probing dept) pre operative		baseline, pre-surgery
Primary	PPD (Periodontal probing dept) post operative		7 days after surgery
Primary	PPD (Periodontal probing dept) 3 months		3 months after surgery.
Primary	PPD (Periodontal probing dept) 12 months		12 months after surgery.
Primary	REC (recession) pre operative		baseline, pre-surgery
Primary	REC (recession) post operative		7 days after surgery
Primary	REC (recession) 3 months		3 months after surgery.
Primary	REC (recession) 12 months		12 months after surgery.
Primary	Radiographic bone Level pre operative		An endoral x-ray was taken baseline, pre-surgery
Primary	Radiographic bone Level post operative		An endoral x-ray was taken 7 days after surgery
Primary	Radiographic bone Level 3 months		An endoral x-ray was taken 3 months after surgery.
Primary	Radiographic bone Level 12 months		An endoral x-ray was taken 12 months after surgery.
Secondary	Adverse Events pre operative	the occurrence of adverse events after the use of amelogenins.	pre-operative
Secondary	Adverse Events post operative	the occurrence of adverse events after the use of amelogenins.	7 days after surgery
Secondary	Adverse Events 3 months	the occurrence of adverse events after the use of amelogenins.	3 months after surgery.
Secondary	Adverse Events 12 months	the occurrence of adverse events after the use of amelogenins.	12 months after surgery.