NCT05890157

Brief Summary

Platelet rich fibrin (PRF) has been widely used in regenerative dentistry since it provides plenty amount of growth factors that enhance wound healing and tissue regeneration. Platelet derived growth factor-BB (PDGF-BB) is a growth factor with essential functions such as regulation of cell migration, proliferation, and differentiation. This study aims to evaluate the efficacy of PRF in improving the clinical periodontal parameters and GCF level of PDGF-BB.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

May 16, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 30, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

June 6, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

May 16, 2023

Last Update Submit

May 25, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Clinical attachment level

    Using UNC-15 periodontal probe measured in mm

    Change from baseline to 1-month and change from baseline to 3-month

  • Change in Periodontal pocket depth measured in mm

    Using UNC-15 periodontal probe measured in mm

    Change from baseline to 1-month and change from baseline to 3-month

Secondary Outcomes (3)

  • Change in plaque index

    Change from baseline to 1-month and change from baseline to 3-month

  • Change in bleeding on probing percentage

    Change from baseline to 1-month and change from baseline to 3-month

  • Change in GCF level of platelet derived growth factor

    Change from baseline to 1-month and change from baseline to 3-month

Study Arms (2)

Test ScRp+PRF

EXPERIMENTAL

This site will treated by ScRp+PRF

Other: PRF

Control ScRp

NO INTERVENTION

This site will treated by ScRp only

Interventions

PRFOTHER

Split mouth randomized clinical trial will be the design of the study. 12 periodontitis patients with 24 opposite shallow periodontal pockets (4-6 mm in depth) will be selected. Randomization in this study will be achieved using toss of coin method in which periodontal pockets were designated either control site or test site. PRF will be used as an adjunct to scaling and root planing to treat the test sites. While control sites will be treated by scaling and root planing only. Clinal periodontal parameters will be recorded and GCF level of PDGF-BB will be measured at baseline and1- and 3- month follow-up visits to evaluate the healing response to the treatment.

Test ScRp+PRF

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • periodontitis

You may not qualify if:

  • Periodontal therapy for the last 3 months
  • Medical history of systemic diseases such as diabetes.
  • Patients wearing dental prosthesis
  • Alcoholic patients
  • Teeth with grade II mobility, endodontic lesions, and teeth with untreated caries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 16, 2023

First Posted

June 6, 2023

Study Start

July 30, 2023

Primary Completion

November 30, 2023

Study Completion

December 30, 2023

Last Updated

June 6, 2023

Record last verified: 2023-05