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Clinical Trials/CTRI/2024/02/062289
CTRI/2024/02/062289Not yet recruitingPhase 4

A Comparative evaluation of Platelet Rich Fibrin Matrix (PRFM) AND Coronally Advanced Flap(CAF) with and without Peripheral Blood Mesenchymal Stem Cells (PBMSCs) in the surgical management of Gingival Recession Type 1 – A Split-mouth Randomised Controlled Trial.

DR JEEVIKA A DAS1 site in 1 country34 target enrollmentStarted: February 15, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
34
Locations
1
Primary Endpoint
9. Gingival Thickness (GT)

Study Overview

Brief Summary

This is a split-mouth, double-blind, randomised controlled clinical trial for comparing the Platelet-Rich Fibrin Matrix (PRFM) and Coronally Advanced Flap (CAF) with and without Peripheral Blood Mesenchymal Stem Cells (PBMSCS) in the surgical management of gingival recession type – 1 for the evaluation of the root coverage potential, regenerative effects, and the impact on gingival thickness.. The sites will be randomly assigned by computer-generated tabulation method into: 1. Test group: treated with CAF and PBMSCS + PRFM (SUPERCELL). 2. Control group: treated with CAF and PRFM alone. The period of study will be divided into a screening phase, a pre-treatment phase, a treatment phase, and a post-treatment phase. The subjects will be recruited after meeting the inclusion and exclusion criteria and obtaining the informed consent during the screening phase. In pre-treatment phase all patients will initially receive phase i therapy consisting of scaling, root planing, and oral hygiene instructions. Clinical parameters like Plaque Index (Pi):  Silness And Loe, Gingival Index (Gi): Loe And Silness, Vertical Component Of The Gingival Recession, Horizontal Component Of The Gingival Recession, Probing Pocket Depth, Clinical Attachment Level, Width Of Attached Gingiva, Width Of Keratinized Gingiva, Gingival Thickness And Root Coverage Esthetic Score will be recorded at baseline, 3 months, 6 months, 1 year and 2 years. The treatment phase will involve withdrawal of blood for the procurement of PRFM and PBMSCs under aseptic conditions. This will be followed by obtaining optimum anaesthesia and reflection of a mucoperiosteal flap, followed by thorough debridement. Subsequently, the defect will be filled with PBMSCS + PRFM (SUPERCELL) in test sites and with PRFM in control sites. The surgical flaps which were elevated will be advanced coronally and sutured. A periodontal pack will be applied. All patients will be prescribed post-operative analgesics and antibiotics.  In the post-treatment phase, recall examinations and maintenance therapy will be scheduled at 1 week, 3, and 6 months, 1 year and 2 years postoperatively. Clinical photographs will be recorded at various stages in the period of the study. The data gathered from the study will be subjected to appropriate statistical analysis.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Systemically healthy male and female subjects in the age group of 20-50 years, with gingival recession type 1 defect on at least 2 adjacent teeth, with no radiographic evidence of interdental bone loss.
  • Probing pocket depth ≤ 3 mm.
  • Adequate width of attached gingiva.

Exclusion Criteria

  • Pregnant/lactating women.
  • Patients on drug therapy known to affect the number and function of platelets in the past 3 months.
  • Patients with abnormal platelet count or having disease affecting platelet count.
  • Patients with immunologic diseases.
  • Current and former smokers.
  • Patients having a history of periodontal therapy in the last 6 months.
  • Any other contraindications for periodontal surgery.

Outcomes

Primary Outcomes

9. Gingival Thickness (GT)

Time Frame: Baseline, 3 months, 6 months, 1 year, and 2 year.

1. Plaque Index (PI): Silness and Loe (1964)

Time Frame: Baseline, 3 months, 6 months, 1 year, and 2 year.

2. Gingival Index (GI): Loe and Silness (1963)

Time Frame: Baseline, 3 months, 6 months, 1 year, and 2 year.

3. Vertical Component Of The Gingival Recession (VGR)

Time Frame: Baseline, 3 months, 6 months, 1 year, and 2 year.

8. Width of Keratinized Gingiva (KG)

Time Frame: Baseline, 3 months, 6 months, 1 year, and 2 year.

4. Horizontal Component Of The Gingival Recession (HGR)

Time Frame: Baseline, 3 months, 6 months, 1 year, and 2 year.

5. Probing Pocket Depth (PPD)

Time Frame: Baseline, 3 months, 6 months, 1 year, and 2 year.

6. Clinical Attachment Level (CAL)

Time Frame: Baseline, 3 months, 6 months, 1 year, and 2 year.

7. Width of Attached Gingiva (WAG)

Time Frame: Baseline, 3 months, 6 months, 1 year, and 2 year.

Secondary Outcomes

  • Root Coverage Esthetic Score (RCES): Cairo et. al. (2009)(6 months, 1 year, 2 year.)

Investigators

Sponsor
DR JEEVIKA A DAS
Sponsor Class
Other [self]

Study Sites (1)

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