Skip to main content
OpenTrials
Completed

NCT Number: NCT02810548

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

King Abdelaziz University. Faculty of dentistry

Jeddah, 21589, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OFD alone

Procedure

Periodontal surgical cleaning procedure

Other names: Periodontal Surgery

Platelet rich Fibrin

Drug

Natural platelet concentrate rich in growth factors

Other names: Natural growth factor

Nanohydroxyapatite

Drug

Synthetic bone graft

Other names: Bone graft

Primary outcomes

  1. Changes in Gingival crevicular fluid (GCF)

    Time frame: 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 outcomes

  1. Changes in Gingival index

    Time frame: up to 3 months

    Gingival index (GI) developed on 1963.

  2. Changes in level of attachment loss

    Time frame: up to 3 months

    Attachment loss: will be measured from the cemento-enamel junction (CEJ) to the apical part of the sulcus.

  3. Changes in probing pocket depth

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 23, 2016
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.