Evaluation of iPRF With Vit.D As an Adjunct to Non-Surgical Therapy in the Treatment of Stage III Periodontitis
- Conditions
- Periodontal Pocket
- Interventions
- Procedure: PMPR onlyProcedure: PMPR+iPRFDrug: PMPR+iPRF+Vit.D
- Registration Number
- NCT06570200
- Lead Sponsor
- Cairo University
- Brief Summary
a clinical trial will be made to investigate the effect of locally applied injectable prf (iPRF) plus vitamin D on the periodontal pockets in stage III periodontitis patients
- Detailed Description
in this clinical trial, the treatment of periodontal pockets in stage III periodontitis patients will be evaluated. the study participants will be divided in 3 groups:
First group \>\> will be treated with professional mechanical plaque removal (PMPR) only.
second group \>\> will be treated with PMPR + locally applied iPRF.
Third group \>\> will be treated with PMPR + locally applied iPRF + vitamin D.
Then the results will be compared after 6 months of the treatment (clinically and radiographically).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 45
- Patients with healthy systemic condition.
- Adult patients ˃ 18 years old.
- Patients with Stage III periodontitis.
- Patients accept 3-month follow-up period (cooperative patients).
- Patients provide an informed consent.
- Presence of prosthetic crowns.
- Extensive interproximal restorations.
- Periodontal therapy within the last 12 months.
- Having undergone surgical periodontal 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 3-month prior to the procedure and till the end of 6-month of follow-up.
- Smokers.
- Pregnant females.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description PMPR only PMPR only scaling and root planing only will be made for group 1 (control group) PMPR + iPRF PMPR+iPRF scaling and root planing plus locally applied iPRF in the periodontal pocket will be made for test group 1. PMPR + iPRF + Vit.D PMPR+iPRF+Vit.D scaling and root planing plus locally applied iPRF and vitamin D in the periodontal pocket will be made for test group 2. vitamin D will be obtained from a commercial product in the Egyptian pharmacies called (Devarol S) in the form of injectable ampoules containing 200000 IU of cholecalciferol (2.5 mg/ml)
- Primary Outcome Measures
Name Time Method pocket depth reduction 6 months estimate the amount of reduction of the pocket depth from baseline and after 6 months of treatment
- Secondary Outcome Measures
Name Time Method clinical attachment level (CAL) gain 6 months the amount of CAL gained from baseline and after 6 months of treatment
Plaque index 6 months comparison of amount of plaque before and after treatment using plaque score
Gingival Marginal Level (GML) 6 months determining the location of gingival margin in relation to the tooth before and after treatment
Post-operative Pain 6 months comparing the pain before and after treatment using Visual Analogue Scale(VAS) Questionnaire. A scale from 0-10 will be used with 0 means no pain and 10 means maximum pain.
Treatment time taken for each groups 6 months a timer will be used to determine the required time of each procedure of the 3 study groups
degree of bone fill or loss 6 months using digital software, evaluation of the radiographic changes will be done at the area diagnosed with periodontal problem and selected for the treatment before and after the intervention.
Bleeding on probing (BOP) 6 months measuring the percentage of BOP using a periodontal probe before and after treatment