Prevention of Mandibular Third Molar Extraction- Associated Periodontal Defects Using Platelet-Rich Fibrin
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Clinical attachment level change
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
One clinician, not involved in patient treatment and not aware of what therapeutic approach was used for the different sites of treatment, performed all clinical measurements (PD, CAL, gingival recession, plaque index and gingival bleeding index) before and after 12 and 18 weeks of surgery.
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients of both genders and any race, between 18 and 35 year-old
- •Periodontally health patients and treated periodontally compromised patients
- •Enrollment on a regular supportive periodontal therapy (SPT) program.
- •Full-mouth plaque score (FMPS)< 25% at baseline;
- •Full-mouth bleeding score (FMBS)< 25% at baseline;
- •Patients having bilateral mesioangular impacted mandibular third molars with the presence of a pocket distally to the mandibular second molar with a probing depth (PD) ≥7 mm
- •Intact buccal and lingual cortical bone of the post-extraction site
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
Outcomes
Primary Outcomes
Clinical attachment level change
Time Frame: 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 Outcomes
- probing depth change(12 and 18 weeks)
- gingival recession change(12 and 18 weeks)
Investigators
Gilberto Sammartino
Full Professor
University of Naples