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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02810548
Enrollment
60
Registered
2016-06-23
Start date
2015-02-01
Completion date
2016-11-30
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bony Defects

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.

Interventions

PROCEDUREOFD alone

Periodontal surgical cleaning procedure

DRUGPlatelet rich Fibrin

Natural platelet concentrate rich in growth factors

DRUGNanohydroxyapatite

Synthetic bone graft

Sponsors

King Abdulaziz University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Changes in Gingival indexup to 3 monthsGingival index (GI) developed on 1963.
Changes in level of attachment lossup to 3 monthsAttachment loss: will be measured from the cemento-enamel junction (CEJ) to the apical part of the sulcus.
Changes in probing pocket depthup to 3 monthsProbing pocket depth (PD): six measurements per tooth will be recorded by using the University of Michigan O periodontal probe with Williams markings.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026