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

UCMSC1

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.

2023-12-01

2024-12-31

2025-03-30

Early phase I

20

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-05-01