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Reconstruction of Deficient Interdental Papilla Using Stem Cells vs Physiological Saline

Gingival Recession, Localized Clinical Trial

Official title:
Reconstruction of Deficient Interdental Papilla Using Allogenic Umbilical Cord-Mesenchymal Stem Cells vs. Physiological Saline: A Randomised Controlled Trial

Clinical Trial Summary

The goal of this study is to assess the reconstruction of interdental papilla following the injection of UC-MSCs or physiological saline in patients with interdental papilla deficiency. Participants will be randomised into 2 groups (intervention vs placebo) to receive the treatment.

Clinical Trial Description

This is a two-arm parallel, prospective, single-center randomised clinical trial, which will be designed based on the guidelines from the Consolidated Standards of Reporting Trials (CONSORT) statement and will be registered in clinicaltrials.gov. Participants will be screened according to the inclusion and exclusion study criteria, and recruited from Orthodontic Postgraduate Clinic, Universiti Malaya. Total sample size will be set at 20 interdental papilla after considering all the sample sizes calculated using different objectives, due to the cost effectiveness, the practicability, and consideration on the risk and complications. This research is divided into 3 phases: pre-operative, operative, and post-operative phase. Pre-operative includes full mouth scaling, baseline data collection (intra-oral scanning for soft tissue; cone beam computed tomography (CBCT) for hard tissue, basic periodontal examination). Then, the black triangle from upper or lower arch will be randomly assigned to two groups: the intervention (Stem cells) group, and the control (saline) group. Operative phase involves injection either with the experimental or control solution. One injection will be given at each papilla set with the volume of 0.1mL with 2.0 x 10⁶ cells per syringe at every visit. A total of 3 injections will be given at the interval of 6 weeks, with a total of 6.0 x 10⁶ cells for each interdental papilla at the end of the 3 injections. Every injection starts with locally application of local anesthetic. For the control group, participants will be injected with 0.9% sodium chloride after locally application of local anesthetic. Post-operatively, at 6, 12, 24 and 36 weeks, data will be collected for analysis. Intra-oral scanning of soft tissue will be done at every visits. CBCT for hard tissue will be done at 36 weeks. At every follow up, basic periodontal examination will be scored for periodontal health supervision. Data collected will be entered and analysed using SPSS 26.0. Images from the scans (soft tissue scans, hard tissue scans) will be superimposed and the difference between the 2 images will be calculated and analysed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06388447
Study type Interventional
Source University of Malaya
Contact
Status Enrolling by invitation
Phase Phase 4
Start date December 1, 2023
Completion date March 30, 2025
View Details
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