NCT06388447|UnknownPhase 4
Loading search results
Sponsor study identifier
interventional
20
1 country
1
Study Start
December 1, 2023
Actual (reported)Primary Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 30, 2023
Actual (reported)December 1, 2023
Actual (reported)April 29, 2024
Actual (reported)December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Orthodontic Postgraduate Clinic
Kuala Lumpur, Kuala Lumpur, 50603, Malaysia
First Submitted
November 30, 2023
First Posted
April 29, 2024
Study Start
December 1, 2023
Actual (reported)Primary Completion
December 31, 2024
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 1, 2024
Record last verified: 2024-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: