Reconstruction of Deficient Interdental Papilla Using Stem Cells vs Physiological Saline

NCT06388447 | Enrolling By Invitation Phase 4

• 1 other identifier: UCMSC1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingival Recession, Localized

Outcome Measures

Primary Outcomes (3)

• Volumetric difference of the deficient interdental papilla pre- and post-intervention

  Intra-oral scanner will be used to scan the dentition and gingiva. Both pre- and post- intervention scans will be exported to Materialise 3-matics software to be superimposed and analyse for the volumetric difference

  9 months

• Volumetric difference of the interdental bone between pre- and post-intervention

  Cone beam computed tomography (CBCT) will be taken before intervention and 9 months after intervention. The CBCT images will be exported to Materialise 3-matics software to be superimposed and volumetric difference would be analysed.

  9 months

• Difference of bone density between pre-and post- intervention

  CBCT will be taken pre-intervention and 9 months after intervention. The CBCT images will be exported to Materialise 3-matics software. A range of "hu" will be selected as "old bone". Different in bone density from the range indicates new bone formation.

  9 months

Study Arms (2)

Umbilical cord-mesenchymal stem cells

EXPERIMENTAL

Injection of the UC-MSC into the interdental papilla using a standardised 1mL syringe will be done. 0.1mL (2millions cells) will be administered per black triangle. If there are three black triangles, only two black triangle will be treated, skipping the middle black triangle to avoid additive effect of the intervention

Biological: Umbilical cord-mesenchymal stem cells

Physiological saline

PLACEBO COMPARATOR

Injection of the 0.9% Sodium chloride (NaCl) into the interdental papilla using a standardised 1mL syringe will be done. 0.1mL of 0.9% NaCl will be administered per black triangle. If there are three black triangles, only two black triangle will be treated, skipping the middle black triangle to avoid additive effect of the intervention

Biological: Umbilical cord-mesenchymal stem cells

Interventions

Umbilical cord-mesenchymal stem cells BIOLOGICAL

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

Physiological saline; Umbilical cord-mesenchymal stem cells

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Orthodontic Postgraduate Clinic

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: April 29, 2024
• Study Start: December 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 30, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)