Menu
Not yet recruiting NCT06570200

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

Phase II Interventional Periodontal Pocket

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PMPR+iPRF, PMPR+iPRF+Vit.D, PMPR only.
Who it may be relevant to
Registry conditions: Periodontal Pocket. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Injectable PRF With Vitamin D As an Adjunct to Non-Surgical Therapy in the Treatment of Stage III Periodontitis. A Randomized Controlled Clinical Trial

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

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).

Interventions

  • Procedure PMPR+iPRF
    locally applied iPRF in the periodontal pocket
  • Drug PMPR+iPRF+Vit.D
    locally applied iPRF plus vitamin D in the periodontal pocket
  • Procedure PMPR only
    scaling and root planing only will be done for the periodontal pocket for the control group

Primary outcome measures

  • pocket depth reduction [Time frame: 6 months]
Secondary outcome measures (7)
  • clinical attachment level (CAL) gain [Time frame: 6 months]
  • Plaque index [Time frame: 6 months]
  • Bleeding on probing (BOP) [Time frame: 6 months]
  • Gingival Marginal Level (GML) [Time frame: 6 months]
  • Post-operative Pain [Time frame: 6 months]
  • Treatment time taken for each groups [Time frame: 6 months]
  • degree of bone fill or loss [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Factorial
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Torumtay Cin G, Lektemur Alpan A, Cevik O. Efficacy of injectable platelet-rich fibrin on clinical and biochemical parameters in non-surgical periodontal treatment: a split-mouth randomized controlled trial. Clin Oral Investig. 2023 Dec 28;28(1):46. doi: 10.1007/s00784-023-05447-8. PMID 38153510

Identifiers

NCT: NCT06570200 · CairoU50022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗