Evaluation of iPRF With Vitamin C in StageII Grade A Periodontitis

Not Applicable

• Conditions: Periodontitis
• Interventions: Other: Group C; Other: Group B

• Registration Number: NCT05129267
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2021-10-03
• Status Verified: 2021-11
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Last Update Submitted: 2021-11-10
• Study First Posted: 2021-11-22
• Last Update Posted: 2021-11-22
• Primary Completion: 2022-06-02
• Study Completion: 2022-06-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Patients with healthy systemic condition.
2. Adult patients ˃ 18 years old.
3. Patients with Stage II Grade A periodontitis.
4. Patients accept 6-months follow-up period (cooperative patients).
5. Patients provide an informed consent.

Exclusion Criteria

1. Presence of prosthetic crowns.
2. Extensive restorations.
3. Periodontal therapy within the last 12 months.
4. Having surgical therapy or undergoing orthodontic treatment.
5. Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
6. The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 6 months of follow-up.
7. Smokers.
8. Pregnant females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Group C	Scaling and Root Debridement + iPRF +Vitamin C
Group B	Group B	Scaling and Root Debridement + iPRF

Primary Outcome Measures

Name	Time	Method
Bleeding on Probing (BOP)	3 months	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

Name	Time	Method
Probing Depth (PD)	6 months	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.
Plaque Index (PI)	6 months	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.
Gingival Marginal Level (GML)	6 months	Measured from the free gingiva to CEJ.
Clinical Attachment Level (CAL)	6 months	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).
Intraoral Radiographs	6 months	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	48 hours	Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 days postoperatively.

Trial Locations

Locations (1)

Faculty of Oral and Dental Medecine-CU; 🇪🇬 Cairo, Egypt