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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05890157
Other study ID # PRF as adjunct to ScRp
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 30, 2023
Est. completion date December 30, 2023

Study information

Verified date May 2023
Source University of Baghdad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Split mouth randomized clinical trial is 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 will be 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 were treated by scaling and root planing only. Clinal periodontal parameters were 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date December 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: •periodontitis Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
PRF
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Baghdad

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Change in plaque index Using Sinless and Loe 1964 plaque index scores Change from baseline to 1-month and change from baseline to 3-month
Secondary Change in bleeding on probing percentage Using UNC-15 periodontal probe Change from baseline to 1-month and change from baseline to 3-month
Secondary Change in GCF level of platelet derived growth factor Using periocol paper to collect GCF and analysed by ELISA test Change from baseline to 1-month and change from baseline to 3-month
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