NCT02810548

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2016

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.8 years

First QC Date

June 8, 2016

Last Update Submit

March 13, 2024

Conditions

Bony Defects

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Changes in Gingival index

    up to 3 months

  • Changes in level of attachment loss

    up to 3 months

  • Changes in probing pocket depth

    up to 3 months

Study Arms (4)

OFD alone

PLACEBO COMPARATOR

Control group: including 15 defects that will receive open flap debridement (OFD).

Procedure: OFD alone

PRF + OFD

ACTIVE COMPARATOR

Test group (1): including 15 defects that will receive platelet rich fibrin (PRF) with open flap debridement (OFD).

Procedure: OFD aloneDrug: Platelet rich Fibrin

Bone + OFD

ACTIVE COMPARATOR

Test group (2): including 15 defects that will receive nanohydroxyapatite bone graft with open flap debridement OFD).

Procedure: OFD aloneDrug: Nanohydroxyapatite

PRF + Bone + OFD

ACTIVE COMPARATOR

Test group (3): including 15 defects that will receive nanohydroxyapatite bone graft with platelet rich fibrin (PRF) after open flap debridement (OFD).

Procedure: OFD aloneDrug: Platelet rich FibrinDrug: Nanohydroxyapatite

Interventions

OFD alonePROCEDURE

Periodontal surgical cleaning procedure

Also known as: Periodontal Surgery
Bone + OFDOFD alonePRF + Bone + OFDPRF + OFD
Platelet rich FibrinDRUG

Natural platelet concentrate rich in growth factors

Also known as: Natural growth factor
PRF + Bone + OFDPRF + OFD
NanohydroxyapatiteDRUG

Synthetic bone graft

Also known as: Bone graft
Bone + OFDPRF + Bone + OFD

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdelaziz University. Faculty of dentistry

Jeddah, 21589, Saudi Arabia

Location

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsOrthopedic ProceduresSurgical Procedures, OperativeTransplantation

Study Officials

  • Maha A Bahammam, DSc

    King Abdelaziz University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Consultant of Periodontology

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 23, 2016

Study Start

February 1, 2015

Primary Completion

November 15, 2016

Study Completion

November 30, 2016

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)