Evaluation of Modified Minimally Invasive Surgical Technique and Platelet Rich Fibrin With or Without Vitamin Pool A and C for Management of Periodontal Intrabony Defects

August 11, 2022 updated by: Dalia Sanaa Abdel Ghaffar, Cairo University

Clinical and Radiographic Evaluation of Modified Minimally Invasive Surgical Technique and Platelet Rich Fibrin With or Without Vitamin Pool A and C for Management of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial

This study aims to assess clinical and radiographic outcomes after the use of vitamins A and C with PRF versus PRF alone in the treatment of periodontal intrabony defect.

Study Overview

Detailed Description

Sites with deep intrabony defects were considered to be at a higher risk of disease progression if patients did not receive any systematic periodontal therapy. Treatment of intrabony defects is an important therapeutic goal of periodontal therapy. The optimal outcome of treatment in intrabony defects is considered to be the absence of bleeding on probing, the presence of shallow pockets associated with periodontal regeneration and limited soft tissue recession.The minimally invasive surgical technique is designed to mobilize just the defect-associated papilla and to reduce flap extension as much as possible. The modified minimally invasive surgical technique has been proposed to further reduce invasiveness and patient side effects by limiting the incision line to the buccal side. This technique fulfilled the maintenance of the interdental papillary height by minimizing its tendency to collapse, increased the likelihood of primary wound closure and reduced the chances of gingival recession.

Platelet-rich fibrin is a powerful healing biomaterial with inherent regenerative capacity and can be used in the treatment of periodontal intrabony defects.

Vitamin C is found to be able to induce osteogenic differentiation and maturation of progenitor cells of PDL without using osteogenic filling material. Also, Vitamin A has a unique property of de-differentiating adult cells into pluripotent cells.

Since combination therapies have been shown to be effective in the regeneration of periodontal defects, this study will evaluate the synergetic effect of vitamins A and C on the periodontal regeneration, together with the most widely used regenerative biomaterial; Platelet-rich fibrin, as an attempt for finding the gold standard in the treatment of intra-bony defects.

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

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 Locations

      • Cairo, Egypt
        • Cairo University
        • Contact:
          • Faculty of Oral and Dental Medicine

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient-related criteria:

    • Patient consulting in the outpatient clinic with periodontitis stage III
    • Able to tolerate surgical periodontal procedures.
    • Patient ready to perform oral hygiene instructions.
    • Compliance with the maintenance program.
    • Provide informed consent.
    • Accepts the 6 months follow-up period.

Teeth related criteria:

  • Mature permanent tooth.
  • Tooth with two or three-walled intra-bony defect, with CAL ≥ 5mm and intra osseous defect ≥ 3mm.

Exclusion Criteria:

  • Patient-related criteria:

    • Medically compromised patients.
    • Pregnant or nursing women.
    • Uncooperative patients.
    • Smokers.

Teeth related criteria:

  • Teeth with one wall intra-bony defect.
  • Teeth with supra-bony defects.
  • Teeth with grade III mobility.

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified minimally invasive surgical technique with PRF and vitamins A and C
Surgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of fresh blood will be drawn by venipuncture of the antecubital vein and collected into a blood collection tube without anticoagulant. Ascorbic Acid will be added to the fresh blood to achieve a concentration of 250 μg/ml, Retinol will also be added to achieve a concentration of 20 μmol/L. The resultant PRF clot will be placed into the intra-osseous defect.
Surgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of fresh blood will be drawn by venipuncture of the antecubital vein and collected into a blood collection tube without anticoagulant. Ascorbic Acid will be added to the fresh blood to achieve a concentration of 250 μg/ml, Retinol will also be added to achieve a concentration of 20 μmol/L. The resultant PRF clot will be placed into the intra-osseous defect.
Active Comparator: Modified minimally invasive surgical technique with PRF
Surgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of whole blood is drawn by venipuncture of the antecubital vein and is collected into two blood collection tubes without anticoagulant for PRF preparation.The resultant PRF clot will be placed into the intra-osseous defect
Surgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of fresh blood will be drawn by venipuncture of the antecubital vein and collected into a blood collection tube without anticoagulant. The resultant PRF clot will be placed into the intra-osseous defect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic linear defect depth (mm)
Time Frame: 9 months
Digital Radiographs using ImageJ software, Measured as the depth of intra-osseous defect from the alveolar crest to the defect.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth (mm)
Time Frame: 9 months
Measured from the gingival margin to the bottom of the gingival sulcus
9 months
Clinical Attachment Level (mm)
Time Frame: 9 months
Measured from the CEJ to the bottom of the gingival sulcus
9 months
Gingival Recession Depth (mm)
Time Frame: 9 months
Measured from the CEJ to the most apical extension of the gingival margin
9 months

Collaborators and Investigators

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

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.

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 (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

October 30, 2023

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (Actual)

August 12, 2022

Study Record Updates

Last Update Posted (Actual)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 11, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PERAUG2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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