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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2026-02-28

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Periodontal Pocket

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

the masking will be applied in the two test groups where iPRF will be used and neither the principle investigator nor the participants will know if vitamin D will be applied to the iPrf or a placebo.

Study Groups

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PMPR only

scaling and root planing only will be made for group 1 (control group)

Group Type ACTIVE_COMPARATOR

PMPR only

Intervention Type PROCEDURE

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

PMPR + iPRF

scaling and root planing plus locally applied iPRF in the periodontal pocket will be made for test group 1.

Group Type EXPERIMENTAL

PMPR+iPRF

Intervention Type PROCEDURE

locally applied iPRF in the periodontal pocket

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)

Group Type EXPERIMENTAL

PMPR+iPRF+Vit.D

Intervention Type DRUG

locally applied iPRF plus vitamin D in the periodontal pocket

Interventions

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PMPR+iPRF

locally applied iPRF in the periodontal pocket

Intervention Type PROCEDURE

PMPR+iPRF+Vit.D

locally applied iPRF plus vitamin D in the periodontal pocket

Intervention Type DRUG

PMPR only

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

Intervention Type PROCEDURE

Other Intervention Names

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scaling plus locally applied iPRF scaling plus locally applied iPRF nd vitamin D scaling only

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes