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NCT Number: NCT06570200

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

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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Key information

Conditions

Periodontal Pocket Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PMPR+iPRF

Procedure

locally applied iPRF in the periodontal pocket

Other names: scaling plus locally applied iPRF

PMPR+iPRF+Vit.D

Drug

locally applied iPRF plus vitamin D in the periodontal pocket

Other names: scaling plus locally applied iPRF nd vitamin D

PMPR only

Procedure

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

Other names: scaling only

Primary outcomes

  1. pocket depth reduction

    Time frame: 6 months

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

Secondary outcomes

  1. clinical attachment level (CAL) gain

    Time frame: 6 months

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

  2. Plaque index

    Time frame: 6 months

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

  3. Bleeding on probing (BOP)

    Time frame: 6 months

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

  4. Gingival Marginal Level (GML)

    Time frame: 6 months

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

  5. Post-operative Pain

    Time frame: 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.

  6. Treatment time taken for each groups

    Time frame: 6 months

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

  7. degree of bone fill or loss

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Fattouh, Bachelor

CONTACT

[email protected]

+201015013868

Prof.Dr Karim Fawzy, professor

CONTACT

[email protected]

+201005444050

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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