Platelet-rich Fibrin and Autogenous Bone vs Enamel Matrix Derivative and Autogenous Bone in Intrabony Defects

NCT03510780 | Unknown DMC

• 1 other identifier: 24042018
• 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) or enamel matrix derivative (EMD) in Induced Periodontal Regeneration ( IPR) 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 a filling 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 EMD + ABG.

Conditions

Periodontal Bone Loss; Periodontal Attachment Loss

Keywords

Platlet rich fibrin; Enamel Matrix Derivative; Bone graft; Non-inferiority study

Outcome Measures

Primary Outcomes (1)

• Periodontal attachment gain

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

  1 year

Secondary Outcomes (1)

• Bone gain

  1 year

Study Arms (2)

EMD treated patients

ACTIVE COMPARATOR

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

Procedure: Periodontal surgery with Enamel Matrix Derivative

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

Interventions

Periodontal surgery with Enamel Matrix Derivative PROCEDURE

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

EMD 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 - 65 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
• and 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; Periodontal Attachment Loss

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor and chairman

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: April 27, 2018
• Study Start: July 2, 2017
• Primary Completion: October 1, 2018
• Study Completion: December 15, 2018
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

IT (1)