Reconstruction of Deficient Interdental Papilla Using Stem Cells vs Physiological Saline (NCT06388447) | Clinical Trial Compass
UnknownPhase 4
Reconstruction of Deficient Interdental Papilla Using Stem Cells vs Physiological Saline
Malaysia20 participantsStarted 2023-12-01
Plain-language 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.
Who can participate
Age range20 Years – 40 Years
SexALL
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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…
What they're measuring
1
Volumetric difference of the deficient interdental papilla pre- and post-intervention
Timeframe: 9 months
2
Volumetric difference of the interdental bone between pre- and post-intervention
Timeframe: 9 months
3
Difference of bone density between pre-and post- intervention