Gingival Recession, LocalizedPhase 4NCT06388447
Reconstruction of Deficient Interdental Papilla Using Stem Cells vs Physiological Saline
A Phase 4 study testing Umbilical cord-mesenchymal stem cells in people with Gingival Recession, Localized, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Localized
- What is being tested?
- Umbilical cord-mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2023to 30 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Orthodontic Postgraduate Clinic
Kuala Lumpur, Kuala Lumpur, 50603
About this study
Official title: Reconstruction of Deficient Interdental Papilla Using Allogenic Umbilical Cord-Mesenchymal Stem Cells vs. Physiological Saline: A Randomised Controlled Trial
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.
Read the detailed description
This is a two-arm parallel, prospective, single-center randomised clinical trial, which will be designed based on the guidelines from the Consolidated Standards of Reporting Trials (CONSORT) statement and will be registered in clinicaltrials.gov. Participants will be screened according to the inclusion and exclusion study criteria, and recruited from Orthodontic Postgraduate Clinic, Universiti Malaya.
Total sample size will be set at 20 interdental papilla after considering all the sample sizes calculated using different objectives, due to the cost effectiveness, the practicability, and consideration on the risk and complications.
This research is divided into 3 phases: pre-operative, operative, and post-operative phase.
Pre-operative includes full mouth scaling, baseline data collection (intra-oral scanning for soft tissue; cone beam computed tomography (CBCT) for hard tissue, basic periodontal examination). Then, the black triangle from upper or lower arch will be randomly assigned to two groups: the intervention (Stem cells) group, and the control (saline) group.
Operative phase involves injection either with the experimental or control solution. 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.
Post-operatively, at 6, 12, 24 and 36 weeks, data will be collected for analysis. Intra-oral scanning of soft tissue will be done at every visits. CBCT for hard tissue will be done at 36 weeks. At every follow up, basic periodontal examination will be scored for periodontal health supervision. Data collected will be entered and analysed using SPSS 26.0. Images from the scans (soft tissue scans, hard tissue scans) will be superimposed and the difference between the 2 images will be calculated and analysed.
- Conditions
- Gingival Recession, Localized
- Being tested
- Umbilical cord-mesenchymal stem cells
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord-mesenchymal stem cellsBiological
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: Umbilical cord-mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession, LocalizedStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388447
- Sponsor's protocol ID
- UCMSC1
- Status last verified
- Apr 2024
- First submitted
- 30 Nov 2023
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of Deficient Interdental Papilla Using Allogenic Umbilical Cord-Mesenchymal Stem Cells vs. Physiological Saline: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06388447
- Acronym / sponsor ID
- UCMSC1
- Conditions
- Gingival Recession, Localized
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a two-arm parallel, prospective, single-center randomised clinical trial, which will be designed based on the guidelines from the Consolidated Standards of Reporting Trials (CONSORT) statement and will be registered in clinicaltrials.gov. Participants will be screened according to the inclusion and exclusion study criteria, and recruited from Orthodontic Postgraduate Clinic, Universiti Malaya.
Total sample size will be set at 20 interdental papilla after considering all the sample sizes calculated using different objectives, due to the cost effectiveness, the practicability, and consideration on the risk and complications.
This research is divided into 3 phases: pre-operative, operative, and post-operative phase.
Pre-operative includes full mouth scaling, baseline data collection (intra-oral scanning for soft tissue; cone beam computed tomography (CBCT) for hard tissue, basic periodontal examination). Then, the black triangle from upper or lower arch will be randomly assigned to two groups: the intervention (Stem cells) group, and the control (saline) group.
Operative phase involves injection either with the experimental or control solution. 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.
Post-operatively, at 6, 12, 24 and 36 weeks, data will be collected for analysis. Intra-oral scanning of soft tissue will be done at every visits. CBCT for hard tissue will be done at 36 weeks. At every follow up, basic periodontal examination will be scored for periodontal health supervision. Data collected will be entered and analysed using SPSS 26.0. Images from the scans (soft tissue scans, hard tissue scans) will be superimposed and the difference between the 2 images will be calculated and analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical cord-mesenchymal stem cells | Experimental | Biological: Umbilical cord-mesenchymal stem cellsInjection 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 |
| Physiological saline | Placebo comparator | Biological: Umbilical cord-mesenchymal stem cellsInjection 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical cord-mesenchymal stem cellsOne 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 | Biological | Physiological saline, Umbilical cord-mesenchymal stem cells |
Primary outcome
Volumetric difference of the deficient interdental papilla pre- and post-intervention
Time frame: 9 months
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
Volumetric difference of the interdental bone between pre- and post-intervention
Time frame: 9 months
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.
Difference of bone density between pre-and post- intervention
Time frame: 9 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Umbilical cord-mesenchymal stem cells in people with Gingival Recession, Localized, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric difference of the deficient interdental papilla pre- and post-intervention (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.