Treatment Of Shallow Periodontal Pockets Using PRF As an Adjunct To Scaling And Root Planing In Periodontitis Patients
Primary Purpose
Periodontitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRF
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Test ScRp+PRF
Control ScRp
Arm Description
This site will treated by ScRp+PRF
This site will treated by ScRp only
Outcomes
Primary Outcome Measures
Change in Clinical attachment level
Using UNC-15 periodontal probe measured in mm
Change in Periodontal pocket depth measured in mm
Using UNC-15 periodontal probe measured in mm
Secondary Outcome Measures
Change in plaque index
Using Sinless and Loe 1964 plaque index scores
Change in bleeding on probing percentage
Using UNC-15 periodontal probe
Change in GCF level of platelet derived growth factor
Using periocol paper to collect GCF and analysed by ELISA test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05890157
Brief Title
Treatment Of Shallow Periodontal Pockets Using PRF As an Adjunct To Scaling And Root Planing In Periodontitis Patients
Official Title
Treatment Of Shallow Periodontal Pockets Using PRF As an Adjunct To Scaling And Root Planing In Periodontitis Patients, Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 30, 2023 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test ScRp+PRF
Arm Type
Experimental
Arm Description
This site will treated by ScRp+PRF
Arm Title
Control ScRp
Arm Type
No Intervention
Arm Description
This site will treated by ScRp only
Intervention Type
Other
Intervention Name(s)
PRF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Clinical attachment level
Description
Using UNC-15 periodontal probe measured in mm
Time Frame
Change from baseline to 1-month and change from baseline to 3-month
Title
Change in Periodontal pocket depth measured in mm
Description
Using UNC-15 periodontal probe measured in mm
Time Frame
Change from baseline to 1-month and change from baseline to 3-month
Secondary Outcome Measure Information:
Title
Change in plaque index
Description
Using Sinless and Loe 1964 plaque index scores
Time Frame
Change from baseline to 1-month and change from baseline to 3-month
Title
Change in bleeding on probing percentage
Description
Using UNC-15 periodontal probe
Time Frame
Change from baseline to 1-month and change from baseline to 3-month
Title
Change in GCF level of platelet derived growth factor
Description
Using periocol paper to collect GCF and analysed by ELISA test
Time Frame
Change from baseline to 1-month and change from baseline to 3-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Treatment Of Shallow Periodontal Pockets Using PRF As an Adjunct To Scaling And Root Planing In Periodontitis Patients
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