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

August 22, 2024 updated by: Ahmed hamed fattouh hamed, Cairo University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PMPR only
scaling and root planing only will be made for group 1 (control group)
Procedure: PMPR only
scaling and root planing only will be done for the periodontal pocket for the control group
Other Names:
  • scaling only
Experimental: PMPR + iPRF
scaling and root planing plus locally applied iPRF in the periodontal pocket will be made for test group 1.
Procedure: PMPR+iPRF
locally applied iPRF in the periodontal pocket
Other Names:
  • scaling plus locally applied iPRF
Experimental: 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)
Drug: PMPR+iPRF+Vit.D
locally applied iPRF plus vitamin D in the periodontal pocket
Other Names:
  • scaling plus locally applied iPRF nd vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pocket depth reduction
Time Frame: 6 months
estimate the amount of reduction of the pocket depth from baseline and after 6 months of treatment
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical attachment level (CAL) gain
Time Frame: 6 months
the amount of CAL gained from baseline and after 6 months of treatment
6 months
Plaque index
Time Frame: 6 months
comparison of amount of plaque before and after treatment using plaque score
6 months
Bleeding on probing (BOP)
Time Frame: 6 months
measuring the percentage of BOP using a periodontal probe before and after treatment
6 months
Gingival Marginal Level (GML)
Time Frame: 6 months
determining the location of gingival margin in relation to the tooth before and after treatment
6 months
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 months
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
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Prof.Dr Manal Hosny, professor, Cairo University
  • Study Director: Prof.Dr Karim Fawzy, Professor, Cairo University
  • Study Director: Prof.Dr Luigi Nibali, Professor, King's College London
  • Study Director: Dr.Manar T El-zanaty, Doctorate, Cairo University
  • Principal Investigator: Ahmed Fattouh, Bachelor, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

August 15, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CairoU50022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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