Bone RegenerationNCT04937023
Ursodeoxycholic Acid (Udca) as a Local Drug Delivery Agent in the Treatment of Intra-bony Defects
A study testing Ursodeoxycholic acid gel in people with Bone Regeneration, run by SVS Institute of Dental Sciences at 1 site in India.
Trial summary
The aim of this study is to evaluate the efficacy of ursodeoxycholic acid as local drug delivery agent in intra- bony defect to achieve bone regeneration. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Regeneration
- What is being tested?
- Ursodeoxycholic acid gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteIndia
- Study dates
- 11 Jun 2021to 30 Dec 2022
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy male and female patients of age>18 years with intrabony defects - two wall or three wall defects and probing pocket depths (PPD) of >3mm will be included
Who cannot join
- Medically compromised patients, pregnant women, heavy smokers, and patients who underwent radiotherapy or chemotherapy will be excluded.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
SVS Institute of Dental Sciences
Hyderabad, Telangana, 509002
R V Chandra, MDS;DNB;PhD, 9908183071, viswachandra@hotmail.com
About this study
Official title: Assessing the Clinical Efficacy of Ursodeoxycholic Acid (Udca) as a Local Drug Delivery Agent in the Treatment of Intra-bony Defects: A Clinico-radiographic Study
The aim of this study is to evaluate the efficacy of ursodeoxycholic acid as local drug delivery agent in intra- bony defect to achieve bone regeneration.
Read the detailed description
Experimental: Main treatment group the prepared UDCA gel will be injected using a syringe with blunt cannula into the defect site.
Comparator: In patients allocated to control group, placebo gel will be injected in to the defect site using a syringe with blunt cannula.
- Conditions
- Bone Regeneration
- Being tested
- Ursodeoxycholic acid gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic acid gelDrug
Also called experimental group
Following scaling and root planing in intrabony defects UDCA gel will be injected
| Study group | Role | What they receive |
|---|---|---|
| UDCA gel will be injected using a syringe with blunt cannula into the defect site | Experimental | In the test group, the prepared UDCA gel will be injected using a syringe with blunt cannula into the two or three wall intra-bony defects with probing pocket depth ≥3mm after performing SRP. Receives: Drug: Ursodeoxycholic acid gel |
| placebo gel will be injected in to the defect site using a syringe with blunt cannula. | Placebo comparator | In patients allocated to control group, placebo gel will be injected in to the defect site using a syringe with blunt cannula after scaling and root planing. Receives: Drug: Ursodeoxycholic acid gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of bone regeneration
Radiovisiography (RVG) will be used to assess bone regeneration achieved post-operatively after 3 months and 6 months.
Measured: Baseline to 6 months
Evaluation if clinical attachment level
Assessment of clinical attachment level (CAL) using UNC-15 probe at baseline and post-operatively at 3 and 6 months.
Measured: Baseline to 6 months
Evaluation of probing pocket depth
Assessment of probing pocket (PPD) depth using UNC- 15 probe at baseline and postoperatively at 3 and 6 months.
Measured: Baseline to 6 months
Secondary outcomes (2)
Evaluation of gingiva
Gingival index (GI) - according to Loe H and Silness P, 1963
Measured: Baseline to 6 months
Evaluation of gingival bleeding
Gingival bleeding index - Ainamo and Bay, 1975
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start11 Jun 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone RegenerationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SVS Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr R Viswa Chandra, SVS Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937023
- Sponsor's protocol ID
- SVSIDS/PERIO/1/2020
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 23 Jun 2021
- 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 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Clinical Efficacy of Ursodeoxycholic Acid (Udca) as a Local Drug Delivery Agent in the Treatment of Intra-bony Defects: A Clinico-radiographic Study
- ClinicalTrials.gov ID
- NCT04937023
- Acronym / sponsor ID
- SVSIDS/PERIO/1/2020
- Conditions
- Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- SVS Institute of Dental SciencesUniversity, hospital or other
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 23 Jun 2021 (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 aim of this study is to evaluate the efficacy of ursodeoxycholic acid as local drug delivery agent in intra- bony defect to achieve bone regeneration.
Detailed description
Experimental: Main treatment group the prepared UDCA gel will be injected using a syringe with blunt cannula into the defect site.
Comparator: In patients allocated to control group, placebo gel will be injected in to the defect site using a syringe with blunt cannula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UDCA gel will be injected using a syringe with blunt cannula into the defect site | Experimental | Drug: Ursodeoxycholic acid gelIn the test group, the prepared UDCA gel will be injected using a syringe with blunt cannula into the two or three wall intra-bony defects with probing pocket depth ≥3mm after performing SRP. |
| placebo gel will be injected in to the defect site using a syringe with blunt cannula. | Placebo comparator | Drug: Ursodeoxycholic acid gelIn patients allocated to control group, placebo gel will be injected in to the defect site using a syringe with blunt cannula after scaling and root planing. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systemically healthy male and female patients of age>18 years with intrabony defects - two wall or three wall defects and probing pocket depths (PPD) of >3mm will be included
Key exclusion criteria (1 listed)
- Medically compromised patients, pregnant women, heavy smokers, and patients who underwent radiotherapy or chemotherapy will be excluded.
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 |
|---|---|---|
| Ursodeoxycholic acid gelAlso: experimental groupFollowing scaling and root planing in intrabony defects UDCA gel will be injected | Drug | UDCA gel will be injected using a syringe with blunt cannula into the defect site, placebo gel will be injected in to the defect site using a syringe with blunt cannula. |
Primary outcome
Evaluation of bone regeneration
Time frame: Baseline to 6 months
Radiovisiography (RVG) will be used to assess bone regeneration achieved post-operatively after 3 months and 6 months.
Evaluation if clinical attachment level
Time frame: Baseline to 6 months
Assessment of clinical attachment level (CAL) using UNC-15 probe at baseline and post-operatively at 3 and 6 months.
Evaluation of probing pocket depth
Time frame: Baseline to 6 months
Assessment of probing pocket (PPD) depth using UNC- 15 probe at baseline and postoperatively at 3 and 6 months.
2 secondary outcomes
Evaluation of gingiva
Time frame: Baseline to 6 months
Evaluation of gingival bleeding
Time frame: Baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ursodeoxycholic acid gel in people with Bone Regeneration, run by SVS Institute of Dental Sciences at 1 site in India.
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 1 inclusion and 1 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 23 Jun 2021. 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 India. 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.
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?
Contact R V Chandra, MDS;DNB;PhD (9908183071, viswachandra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of bone regeneration (time frame: Baseline to 6 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 23 Jun 2021.