Clinical trial NCT04314726: Verify if Amelogenins Had Some Benefits in Improving Lower 2nd Molar Periodontal Healing After 3rd Molar Extraction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attachment Loss, Periodontal
Teeth, Impacted
Keywords: third molar surgery
amelogenin
periodontal pocket
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, split-mouth, placebo-controlled, single blind clinical trial, a pilot study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: CAL (Clinical attachment level) pre operative
timeFrame: baseline, pre-surgery
measure: CAL (Clinical attachment level) post operative
timeFrame: 7 days after surgery
measure: CAL (Clinical attachment level) 3 months
timeFrame: 3 months after surgery.
measure: CAL (Clinical attachment level) 12 months
timeFrame: 12 months after surgery.
measure: PPD (Periodontal probing dept) pre operative
timeFrame: baseline, pre-surgery
measure: PPD (Periodontal probing dept) post operative
timeFrame: 7 days after surgery
measure: PPD (Periodontal probing dept) 3 months
timeFrame: 3 months after surgery.
measure: PPD (Periodontal probing dept) 12 months
timeFrame: 12 months after surgery.
measure: REC (recession) pre operative
timeFrame: baseline, pre-surgery
measure: REC (recession) post operative
timeFrame: 7 days after surgery
measure: REC (recession) 3 months
timeFrame: 3 months after surgery.
measure: REC (recession) 12 months
timeFrame: 12 months after surgery.
measure: Radiographic bone Level pre operative
timeFrame: An endoral x-ray was taken baseline, pre-surgery
measure: Radiographic bone Level post operative
timeFrame: An endoral x-ray was taken 7 days after surgery
measure: Radiographic bone Level 3 months
timeFrame: An endoral x-ray was taken 3 months after surgery.
measure: Radiographic bone Level 12 months
timeFrame: An endoral x-ray was taken 12 months after surgery.
Secondary outcomes:
measure: Adverse Events pre operative
timeFrame: pre-operative
measure: Adverse Events post operative
timeFrame: 7 days after surgery
measure: Adverse Events 3 months
timeFrame: 3 months after surgery.
measure: Adverse Events 12 months
timeFrame: 12 months after surgery.
Other outcomes:
Locations:
Study officials:
affiliation: University of Roma La Sapienza
name: Roberto Pippi, MDDS
role: PRINCIPAL_INVESTIGATOR
References: