Evaluation of Platelets Rich Fibrin and Nanohydroxyapatite in the Treatment of Intrabony Defects

Early Phase 1

Completed

• Conditions: Bony Defects
• Interventions: Procedure: OFD alone; Drug: Nanohydroxyapatite; Drug: Platelet rich Fibrin

• Registration Number: NCT02810548
• Lead Sponsor: King Abdulaziz University

Brief Summary

Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. Researches had demonstrated the benefits of platelet concentrates bine grafts in osseous regeneration in the areas of periodontal surgery.

Aim of the study: to evaluate the effect of PRF with/without nanohydroxyapatite in periodontal intrabony defects.

Detailed Description

Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. The regenerative and wound healing potential of platelets has attracted much attention over the last few years. Researches had demonstrated the benefits of platelet concentrates in osseous regeneration in the areas of periodontal surgery and implantology. In addition, nanohydroxyapatite was shown to be unsheathed by newly formed bone and partly replaced by it, but resorbed very slowly, as shown in animal experiments after 9 months or in clinical studies after a 6-month observation period. The clinical and biochemical studies evaluating the regenerative effect of PRF alone or in combination with nanohydroxyapatite in periodontal intrabony defects are still deficient.

Aim of the study: to evaluate clinical and biochemical effect of PRF with/without nanohydroxyapatite in treatment of human intrabony defects.

Study Timeline

• Study Start: 2015-02-01
• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-23
• Primary Completion: 2016-11-15
• Study Completion: 2016-11-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• All patients are free from systemic illness.
• All patients should be diagnosed as having chronic periodontitis.
• Patients should be cooperative, motivated and willing to follow our treatment protocol and follow up visits.
• Patients selected had not received antibiotics or anti-inflammatory therapy in the 6 months prior to examination.

Exclusion Criteria

• Presence of areas of periodontal pocket of (probing depth ≥5 and clinical attachment level (CAL) ≥ 3).
• Patients who have received any type of periodontal treatment in the past 6 months prior to examination.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRF + OFD	OFD alone	Test group (1): including 15 defects that will receive platelet rich fibrin (PRF) with open flap debridement (OFD).
Bone + OFD	OFD alone	Test group (2): including 15 defects that will receive nanohydroxyapatite bone graft with open flap debridement OFD).
Bone + OFD	Nanohydroxyapatite	Test group (2): including 15 defects that will receive nanohydroxyapatite bone graft with open flap debridement OFD).
PRF + Bone + OFD	OFD alone	Test group (3): including 15 defects that will receive nanohydroxyapatite bone graft with platelet rich fibrin (PRF) after open flap debridement (OFD).
PRF + Bone + OFD	Nanohydroxyapatite	Test group (3): including 15 defects that will receive nanohydroxyapatite bone graft with platelet rich fibrin (PRF) after open flap debridement (OFD).
OFD alone	OFD alone	Control group: including 15 defects that will receive open flap debridement (OFD).
PRF + OFD	Platelet rich Fibrin	Test group (1): including 15 defects that will receive platelet rich fibrin (PRF) with open flap debridement (OFD).
PRF + Bone + OFD	Platelet rich Fibrin	Test group (3): including 15 defects that will receive nanohydroxyapatite bone graft with platelet rich fibrin (PRF) after open flap debridement (OFD).

Primary Outcome Measures

Name	Time	Method
Changes in Gingival crevicular fluid (GCF)	up to 3 weeks.	GCF will be collected after removing saliva and supra-gingival plaque using methylcellulose filter paper strip that will be inserted in the periodontal pocket and will be let in for 30 seconds.

Secondary Outcome Measures

Name	Time	Method
Changes in Gingival index	up to 3 months	Gingival index (GI) developed on 1963.
Changes in level of attachment loss	up to 3 months	Attachment loss: will be measured from the cemento-enamel junction (CEJ) to the apical part of the sulcus.
Changes in probing pocket depth	up to 3 months	Probing pocket depth (PD): six measurements per tooth will be recorded by using the University of Michigan O periodontal probe with Williams markings.

Trial Locations

Locations (1)

King Abdelaziz University. Faculty of dentistry; 🇸🇦 Jeddah, Saudi Arabia