Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ENROLLING BY INVITATION

NCT06388447

PHASE4

Reconstruction of Deficient Interdental Papilla Using Stem Cells vs Physiological Saline

Sponsor: University of Malaya

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-12-01

Completion Date

2025-03-30

Last Updated

2024-05-01

Healthy Volunteers

Yes

Conditions

Gingival Recession, Localized

Interventions

BIOLOGICAL

Umbilical cord-mesenchymal stem cells

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

Inclusion Criteria: * Adults aged 20 - 40 years * Non-smoker * Able to understand English * Subjects who are able to attend follow up during the clinical trial * Subjects who are able to maintain oral hygiene (\< 10% FMPS) with BPE score 0, 1, or 2 at the upper anterior or lower anterior sextant * Subjects having at least one deficient interdental papilla in the upper or lower arch or both in the anterior region (from canine to contralateral canine) with papillary deficiency type I or II, according to Nordland and Tarnow classification * No history of regular medication intake (nifedipine, calcium channel blockers, cyclosporine, phenytoin, etc) * Teeth free from caries, proximal restorations, fixed prosthesis or orthodontic fixed appliances (except for fixed retainer that does not encroach on black triangle) * No open contacts between affected teeth * No history of periodontal surgical or non-surgical treatment (Root surface debridement) over the last six months at the area of interest * Probing pocket depth ≤ 4mm without bleeding on probing at the area of interest Exclusion Criteria: * Passive smoker/ former smoker/ electronic smoker * Alcoholic * Pregnant or breastfeeding females * Subjects with current or previous drug intake that may predispose to gingival enlargement (nifedipine, calcium channel blockers, cyclosporin, phenytoin, etc) * Subjects with medical conditions that may affect periodontal healing/ Reconstruction (diabetes, cardiovascular disease, stroke, asthma) * Subjects with physical impairment, orofacial deformities * Subjects with documented drug allergic, or history of allergic reaction to any constituents of injection * Subjects who had active or past history of neoplasia * Subjects who are on active orthodontic treatment/ require active tooth movement at the area of interest * Subjects with probing pocket depth of more than 4mm with bleeding on probing at the area of interest * Subjects with full mouth plaque score \>10% * Subjects with a history of periodontal surgical or non-surgical treatment over the last six months at the area of interest

Locations (1)

Orthodontic Postgraduate Clinic

Kuala Lumpur, Kuala Lumpur, Malaysia