Treatment Of Shallow Periodontal Pockets Using PRF As an Adjunct To Scaling And Root Planing In Periodontitis Patients
1 other identifier
interventional
12
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
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
CompletedFirst Posted
Study publicly available on registry
June 6, 2023
CompletedStudy Start
First participant enrolled
July 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedJune 6, 2023
May 1, 2023
4 months
May 16, 2023
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
EXPERIMENTALThis site will treated by ScRp+PRF
Control ScRp
NO INTERVENTIONThis site will treated by ScRp only
Interventions
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.
Eligibility Criteria
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
Condition Hierarchy (Ancestors)
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