Evaluation of iPRF With Vitamin C in StageII Grade A Periodontitis
Primary Purpose
Periodontitis
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Group B
Group C
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Patients with healthy systemic condition.
- Adult patients ˃ 18 years old.
- Patients with Stage II Grade A periodontitis.
- Patients accept 6-months follow-up period (cooperative patients).
- Patients provide an informed consent.
Exclusion Criteria:
- Presence of prosthetic crowns.
- Extensive restorations.
- Periodontal therapy within the last 12 months.
- Having surgical therapy or undergoing orthodontic treatment.
- Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
- The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 6 months of follow-up.
- Smokers.
- Pregnant females.
Sites / Locations
- Faculty of Oral and Dental Medecine-CURecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Group B
Group C
Group A
Arm Description
Scaling and Root Debridement + iPRF
Scaling and Root Debridement + iPRF +Vitamin C
Scaling and Root Debridement
Outcomes
Primary Outcome Measures
Bleeding on Probing (BOP)
Gentle probing of the orifice of the gingival crevice. The periodontal probe will be inserted 1 to 2 mm into the gingival sulcus starting at one interproximal area and moving to the other. If bleeding occurs within 10 seconds a positive finding is recorded.
Secondary Outcome Measures
Probing Depth (PD)
Measured from the gingival margin to the bottom of the gingival sulcus. Each tooth will be probed with a light force not exceeding 25 grams at 6 sites.
Clinical Attachment Level (CAL)
Measured from the CEJ to the bottom of the gingival sulcus, or will be calculated as the algebraic sum of gingival recession and PD measurements for each site. Each tooth will be probed with a light force not exceeding 25 grams at six points: (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual).
Gingival Marginal Level (GML)
Measured from the free gingiva to CEJ.
Plaque Index (PI)
Teeth in each quadrant will be dried with a blast of air, and presence of visible dental plaque will be recorded with scores 0, 1, 2, 3.
Intraoral Radiographs
A customized X-ray positioning stent will be fabricated to allow easy and accurate radiographing and retain the plastic film holder in the paralleling radiographic technique.
Post-Operative Pain
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 days postoperatively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05129267
Brief Title
Evaluation of iPRF With Vitamin C in StageII Grade A Periodontitis
Official Title
Evaluation of Injectable PRF With Vitamin C as an Adjunct to Non-surgical Therapy in the Treatment of Stage II Grade A Periodontitis. A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2021 (Actual)
Primary Completion Date
June 2, 2022 (Anticipated)
Study Completion Date
June 2, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparing the effect of using vitamin C with injectable PRF as a locally delivered adjunct to scaling and root planing versus scaling and root planing with local delivery of injectable PRF and scaling and root planing alone on the clinical parameters in Stage II Grade A Periodontitis patients.
Detailed Description
The conventional approach:
Group 1: Scaling and root planing alone using Gracey curettes and ultrasonic scalers.
Group 2: Scaling and root planing using Gracey curettes and ultrasonic scalers with local delivery of injectable PRF using an insulin syringe with the blunt needle inserted into the bottom of the periodontal pocket through a template to hold the locally delivered injectable PRF.
The intervention approach:
Scaling and root planing using Gracey curettes and ultrasonic scalers with local delivery of vitamin C (250 μM) and injectable PRF, using an insulin syringe with the blunt needle inserted into the bottom of the periodontal pocket through a template to hold the locally delivered vitamin C and injectable PRF for a longer time.
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
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Scaling and Root Debridement + iPRF
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Scaling and Root Debridement + iPRF +Vitamin C
Arm Title
Group A
Arm Type
No Intervention
Arm Description
Scaling and Root Debridement
Intervention Type
Other
Intervention Name(s)
Group B
Intervention Description
Scaling and Root debridement + iPRF
Intervention Type
Other
Intervention Name(s)
Group C
Intervention Description
Scaling and Root debridement + iPRF together with vitamin C
Primary Outcome Measure Information:
Title
Bleeding on Probing (BOP)
Description
Gentle probing of the orifice of the gingival crevice. The periodontal probe will be inserted 1 to 2 mm into the gingival sulcus starting at one interproximal area and moving to the other. If bleeding occurs within 10 seconds a positive finding is recorded.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Probing Depth (PD)
Description
Measured from the gingival margin to the bottom of the gingival sulcus. Each tooth will be probed with a light force not exceeding 25 grams at 6 sites.
Time Frame
6 months
Title
Clinical Attachment Level (CAL)
Description
Measured from the CEJ to the bottom of the gingival sulcus, or will be calculated as the algebraic sum of gingival recession and PD measurements for each site. Each tooth will be probed with a light force not exceeding 25 grams at six points: (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual).
Time Frame
6 months
Title
Gingival Marginal Level (GML)
Description
Measured from the free gingiva to CEJ.
Time Frame
6 months
Title
Plaque Index (PI)
Description
Teeth in each quadrant will be dried with a blast of air, and presence of visible dental plaque will be recorded with scores 0, 1, 2, 3.
Time Frame
6 months
Title
Intraoral Radiographs
Description
A customized X-ray positioning stent will be fabricated to allow easy and accurate radiographing and retain the plastic film holder in the paralleling radiographic technique.
Time Frame
6 months
Title
Post-Operative Pain
Description
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 days postoperatively.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with healthy systemic condition.
Adult patients ˃ 18 years old.
Patients with Stage II Grade A periodontitis.
Patients accept 6-months follow-up period (cooperative patients).
Patients provide an informed consent.
Exclusion Criteria:
Presence of prosthetic crowns.
Extensive restorations.
Periodontal therapy within the last 12 months.
Having surgical therapy or undergoing orthodontic treatment.
Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 6 months of follow-up.
Smokers.
Pregnant females.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Ab Sherif
Phone
01118222827
Email
mohamedsherif@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of Oral and Dental Medecine-CU
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Ab Sherif, Master
Phone
01118222827
Email
mohamedsherif@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of iPRF With Vitamin C in StageII Grade A Periodontitis
We'll reach out to this number within 24 hrs