Platelet-Rich Fibrin and Anorganic Bovine Bone vs Collagen Membrane and Anorganic Bovine Bone in Intrabony Defects

NCT03715374 | Completed DMC

• 1 other identifier: 19102018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary outcome of periodontal reconstructive therapy is to regenerate all tissues of the periodontium including a functional periodontal ligament, alveolar bone and cementum. A number of treatment modalities including the use of bone grafts, guided tissue regeneration (GTR), and the addition of biological agents have been used with large heterogeneity in the clinical and histological outcomes. The rationale of using a filling material when treating unfavorable and large intrabony defects (IBDs) with membranes or biological agents consists of sustaining the overlying soft tissues in the presence of a non-contained defect's architecture, at the same time enhancing the stability of coagulum; and facilitating the proliferation of mesenchymal progenitor cells. Among bone grafts available, anorganic bone bone (ABB) have been widely used in periodontics for the treatment of IBDs In recent years, the increasing understanding of the role of growth factors (GFs) in the wound healing process suggested the use of these biological agents in the regenerative treatment of periodontal bony defects. Noninferiority trials are designed to demonstrate that the effect of a new treatment is adequately similar to an active control by more than a specified margin The aim of this study is to verify if the combined use of PRF (Platelet Rich Fibrin) and ABB in the management of IBDs may be a treatment modality that is clinically "not inferior" compared to the membrane + ABB one, since the combined periodontal regenerative technique has been already tested in literature as a "gold standard" periodontal regenerative technique.

Conditions

Periodontal Attachment Loss; Periodontal Bone Loss; Periodontal Diseases

Keywords

Platelet rich fibrin; bone graft; non inferiority trial

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)

PRF+ABB treated patients

EXPERIMENTAL

Periodontal surgery with Platelet Rich Fibrin is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. Anorganic bovine bone material will be applied to the entire root surfaces ; then, A prf membrane is positioned above the filling material. Finally the flap will be positionated and sutures completed by interrupted sutures.

Procedure: Periodontal Surgery with PRF+ABB

Collagen Membrane + ABB treated patients

ACTIVE COMPARATOR

Periodontal surgery with collagen membrane is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. Anorganic bovine bone material will be applied to the entire root surfaces ; then, A collagen membrane is positioned above the filling material. Finally the flap will be positionated and sutures completed by interrupted sutures.

Procedure: Periodontal Surgery with Collagen Membrane +ABB

Interventions

Periodontal Surgery with PRF+ABB PROCEDURE

Patients will be treated by periodontal surgical flaps with the addition of PRF+ Anorganic Bovine Bone filling material

PRF+ABB treated patients

Periodontal Surgery with Collagen Membrane +ABB PROCEDURE

Patients will be treated by periodontal surgical flaps with the addition of Collagen Membrane + Anorganic Bovine Bone filling material

Collagen Membrane + ABB 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
• 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

Periodontal Attachment Loss; Alveolar Bone Loss; Periodontal Diseases

Condition Hierarchy (Ancestors)

Periodontal Atrophy; Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal 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: October 19, 2018
• First Posted: October 23, 2018
• Study Start: November 6, 2017
• Primary Completion: November 16, 2018
• Study Completion: December 12, 2018
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

IT (1)