Evaluation of iPRF With Vit.D As an Adjunct to Non-Surgical Therapy in the Treatment of Stage III Periodontitis

Phase 2Not Yet RecruitingNCT06570200

Cairo University45 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Periodontal Pocket

Interventions

PMPR+iPRFPROCEDURE

locally applied iPRF in the periodontal pocket

PMPR+iPRF+Vit.DDRUG

locally applied iPRF plus vitamin D in the periodontal pocket

PMPR onlyPROCEDURE

scaling and root planing only will be done for the periodontal pocket for the control group

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with healthy systemic condition. 2. Adult patients ˃ 18 years old. 3. Patients with Stage III periodontitis. 4. Patients accept 3-month follow-up period (cooperative patients). 5. Patients provide an informed consent. Exclusion Criteria: 1. Presence of prosthetic crowns. 2. Extensive interproximal restorations. 3. Periodontal therapy within the last 12 months. 4. Having undergone surgical periodontal 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 3-month prior to the procedure and till the end of 6-month of follow-up. 7. Smokers. 8. Pregnant females.

Outcomes

Primary Outcomes

pocket depth reduction

estimate the amount of reduction of the pocket depth from baseline and after 6 months of treatment

Time frame: 6 months

Secondary Outcomes

clinical attachment level (CAL) gain

the amount of CAL gained from baseline and after 6 months of treatment

Time frame: 6 months

Plaque index

comparison of amount of plaque before and after treatment using plaque score

Time frame: 6 months

Bleeding on probing (BOP)

measuring the percentage of BOP using a periodontal probe before and after treatment

Time frame: 6 months

Gingival Marginal Level (GML)

determining the location of gingival margin in relation to the tooth before and after treatment

Time frame: 6 months

Post-operative Pain

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.

Time frame: 6 months

Treatment time taken for each groups

a timer will be used to determine the required time of each procedure of the 3 study groups

Time frame: 6 months

degree of bone fill or loss

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.

Central Contacts

Ahmed Fattouh, Bachelor

CONTACT

+201015013868 ahmed.fattouh@dentistry.cu.edu.eg

Prof.Dr Karim Fawzy, professor

CONTACT

+201005444050 karim.fawzy@dentistry.cu.edu.eg

Data from ClinicalTrials.gov

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