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

Bony Defects Clinical Trial

Official title:

Clinical and Biochemical Evaluation of Platelets Rich Fibrin (PRF) and Nanohydroxyapatite in the Treatment of Intrabony Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810548
• Other study ID #: 032-16
• Status: Completed
• Phase: Early Phase 1
• Start date: February 1, 2015
• Est. completion date: November 30, 2016

Study information

• Verified date: March 2024
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2016
• Est. primary completion date: November 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bony Defects

Intervention

Procedure:
• OFD alone
Periodontal surgical cleaning procedure

Drug:
• Platelet rich Fibrin
Natural platelet concentrate rich in growth factors
• Nanohydroxyapatite
Synthetic bone graft

Locations

Country	Name	City	State
Saudi Arabia	King Abdelaziz University. Faculty of dentistry	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Gingival crevicular fluid (GCF)	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.	up to 3 weeks.
Secondary	Changes in Gingival index	Gingival index (GI) developed on 1963.	up to 3 months
Secondary	Changes in level of attachment loss	Attachment loss: will be measured from the cemento-enamel junction (CEJ) to the apical part of the sulcus.	up to 3 months
Secondary	Changes in probing pocket depth	Probing pocket depth (PD): six measurements per tooth will be recorded by using the University of Michigan O periodontal probe with Williams markings.	up to 3 months