Prevention of Mandibular Third Molar Extraction- Associated Periodontal Defects Using Platelet-Rich Fibrin

Not Applicable

Completed

• Conditions: Molar, Third; Periodontal Pocket; Periodontal; Lesion
• Interventions: Procedure: extraction of mandibular third molar

• Registration Number: NCT04033744
• Lead Sponsor: University of Naples

Brief Summary

The extraction of deep impacted mandibular third molar may cause periodontal defects at the distal root of the second molar. The aim of this study was to evaluate the ability of platelet-rich fibrin (PRF) in preventing periodontal complications at the distal root of the second molar adjacent to the extracted third molar.

Detailed Description

Eighteen young patients with bilateral impacted mandibular third molars will be selected. All 36 cases of impactions will be selected for a split mouth study and randomly treated by using 2 different therapeutic approaches, thereby yielding 2 different study groups, each of which is composed of 18 cases: in one side the post-extraction socket is left healing spontaneously, on the other side the socket is filled with PRF.

CAL at the distal surface of the lower second molar is chosen as primary outcome.

Criteria will be the presence of a pocket distal to the mandibular second molar with a probing depth \>7 mm and a probing clinical attachment level \>6mm.

This study was designed as a single-blind research since subjects will be unaware of their treatment allocation. A software will be used to produce a random sequence of 18 integer numbers without duplicates generated from atmospheric noise and concealed in closed envelopes by one of the investigators. At the time of the patient's first surgery, the envelope will be opened and patient allocated either to group 1 (PRF on the right side, spontaneous healing on the left side), for allocation numbers 1-9, or group 2 (spontaneous healing on the right side, PRF on the left side), for allocation numbers 10-18.

One clinician, not involved in patient treatment and not aware of what therapeutic approach used for the different sites of treatment, will perform all clinical measurements (PD, CAL, gingival recession, plaque index and gingival bleeding index) before and after 12 and 18 weeks of surgery.

Clinical and radiographical measurements will be recorded at 12 and 18 weeks after the surgery. The Student t test will be used to compare the differences between the 2 groups.

Study Timeline

• Study Start: 2018-01-07
• Status Verified: 2019-07
• Primary Completion: 2019-07-19
• Study Completion: 2019-07-19
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-26
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

• General contra-indications for surgery (systemic disease, compromised immune system etc);
• Tobacco smoking
• Pregnancy and lactation
• Untreated periodontal conditions;
• Acute infection in the site of the extraction
• Patients taking any medications which might interfere with coagulation
• Platelet count < 150000/mm3

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PRF (platelet-rich fibrin)	extraction of mandibular third molar	PRF will be used after the extraction of the third molar to prevent periodontal defects to second molar
spontaneous healing	extraction of mandibular third molar	after the extraction of the third molar the socket will be left to heal spontaneously

Primary Outcome Measures

Name	Time	Method
Clinical attachment level change	12 and 18 weeks	the clinical attachment level is the distance between the gingival margin to the cemento-enamel junction.; the measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks.

Secondary Outcome Measures

Name	Time	Method
probing depth change	12 and 18 weeks	The probing depth is the distance from the free end of the gingival margin to the bottom of the periodontal pocket. The measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks.
gingival recession change	12 and 18 weeks	The distance between the cemento-enamel junction and gingival margin gives the level of recession.; The measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks.

Trial Locations

Locations (1)

Gilberto Sammartino; 🇮🇹 Naples, Italy