Platelet-rich Fibrin and Autogenous Bone vs Membrane and Autogenous Bone in Intrabony Defects

NCT04043754 | Completed

• 1 other identifier: 062019
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, the most positive documented outcomes of periodontal regenerative therapy (PRT) in intrabony defects (IBDs) have been achieved with a combination of bone grafts ( BGs) and a regeneration material like membranes in guided tissue regeneration ( GTR) technique. Among the graft materials only autogenous bone grafts ( ABGs).and demineralized freeze-dried bone allografts (DFDBA), are considered regenerative materials. Polypeptide growth factors revealed a potential application in PRT periodontal because are the biological mediators during wound healing and regeneration and autologous platelet concentrates ( PC) constitute a safe and convenient approach to deliver them. Among PC, platelet-rich fibrin ( PRF) belongs to a group of second-generation blood autologous products prepared by peripheral blood centrifugation without any nonclotting agent, so to obtain a dense three-dimensional clot architecture that concentrates platelets, fibrin, leukocytes, cytokines, and sustain cellular migration. This clot is then compressed to obtain elastic and very strong membranes that can be used directly as membranes or as an agent, after chopping, alone or in combination with BGs. Several studies demonstrate that PRF is effective in promoting bone regeneration (BR) when used alone or in combination with BG during oral/ periodontal surgery. To date, there are very few published clinical controlled trials that compare the results of PRF + BGs to the outcomes of PRF / BG alone in the treatment of IBDs and no study about PRF + ABG in the same defects. Only one case report tested the use of PRF + ABG mixed with bovine hydroxyapatite in the treatment of insufficient alveolar ridge width in aesthetic area. The aim of the present study is to verify if the combined use of PRF + ABG in the management of IBDs may be a treatment modality clinically "not inferior" to that with Membrane + ABG.

Conditions

Periodontal Bone Loss

Outcome Measures

Primary Outcomes (1)

• Periodontal attachment gain

  Change of the distance between the cementum-enamel junction and the depth of the probable site

  6 months

Study Arms (2)

PRF treated patients

EXPERIMENTAL

Periodontal surgery with Platelet Rich Fibrin is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. Autogenous corticocancellous BG material will be collected using bone scrapers , the PRF membrane cut into small pieces and mixed with the ABG will be placed within the IBDs until they will be completely filled. Then the other two PRF membranes in each patient will be adapted over the grafted defect Finally horizontal mattress and interrupted sutures will be carried out.

Procedure: Periodontal surgery with Platlet Rich fibrin

GTR treated patients

ACTIVE COMPARATOR

Periodontal surgery with MEMBRANE is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. Autogenous corticocancellous BG material will be collected using bone scrapers ; then, ABG will be applied alternatively with MEMBRANE into the IBD according to the "sandwich" technique until the IBD will be completely filled. Finally the flap will be repositioned and sutures completed by interrupted sutures.

Procedure: Procedure/Surgery: Periodontal surgery with Membrane

Interventions

Procedure/Surgery: Periodontal surgery with Membrane PROCEDURE

Patients will be treated by periodontal surgical flaps with the addition of Membrane+ bone graft

GTR treated patients

Periodontal surgery with Platlet Rich fibrin PROCEDURE

Patients will be treated by periodontal surgical flaps with the addition of PRF + bone graft

PRF treated patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a full-mouth plaque score (FMPS) 25 and a full-mouth bleeding score (FMBS) 26 \< 20% at the time of surgery
• to have at least 20 teeth,; at least 1 tooth exhibiting vertical bone loss detected by radiographic examination (alveolar crest level (ACL) - bottom of the defect (BD) distance - -Bone defect depth (BDD) ≥ 4 mm and a probing pocket depth (PPD) ≥ 5mm when evaluated 12 weeks after phase I non- surgical therapy \[ scaling and root planing ( SRP)\]

You may not qualify if:

• no systemic diseases
• no medications affecting periodontal status during the previous 6 months
• not pregnant or lactating; non-smoker
• no periodontal therapy in the 2 previous years, no inadequate endodontic treatment, no dental mobility

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

G. d'Annunzio University

Chieti, CH, 66100, Italy

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• michele paolantonio

  università G. D'annunzio Chieti-Pescara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Periodontology

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 2, 2019
• Study Start: June 10, 2018
• Primary Completion: March 16, 2023
• Study Completion: July 15, 2023
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)