Bone RegenerationNCT06439264
Assessing the Clinical Efficacy of Bentonite Clay Gel on Bone Regeneration in the Treatment of Intra-bony Defects: A Clinico-radiograph Study
A study testing bentonite clay gel with hydroxyapatite in people with Bone Regeneration, run by Dr R Viswa Chandra at 1 site in India.
Trial summary
The aim of this study is to evaluate osseous regeneration efficacy of bentonite gel with hydroxyapatite in comparison with hydroxyapatite incase of intrabony defects The test group includes patients with intrabony defects where flap surgery is will be performed and bentonite clay gel with HA will be placed and in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Regeneration
- What is being tested?
- bentonite clay gel with hydroxyapatite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 3 May 2023to May 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy male and female patients of age >18 years
- two-walled or three-walled intrabony defects and
- probing pocket depths (PPD) of ≥ 5mm.
Who cannot join
- Medically compromised patients,
- patients <18 years of age,
- pregnant women,
- heavy smokers, and
- patients who underwent radiotherapy or chemotherapy are excluded.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Svs Dental College
Mahbūbnagar, Telangana, 509002
VISWA CHANDRA PROFESSOR, 9908183071, rampalliviswa@gmail.com
About this study
The aim of this study is to evaluate osseous regeneration efficacy of bentonite gel with hydroxyapatite in comparison with hydroxyapatite incase of intrabony defects
The test group includes patients with intrabony defects where flap surgery is will be performed and bentonite clay gel with HA will be placed and in control group only HA is placed.
Read the detailed description
Experimental: Main treatment group bentonite with hydroxyaatite is added into the defect site.
Comparator: In patients allocated to control group,only hydroxyapatite is added.
- Conditions
- Bone Regeneration
- Being tested
- bentonite clay gel with hydroxyapatite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bentonite clay gel with hydroxyapatiteOther
bentonite clay gel presents great potential for bone healing and it leads to the formation of interconnected microporous structure, which can promote native cell infiltration, proliferation,
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | In test group, after reflection of flap and degranulation, bone graft i.e., bentonite clay gel with hydroxyapatite will be placed in the void created by the defect and sutures will be placed Receives: Other: bentonite clay gel with hydroxyapatite |
| control group | Active comparator | In control group, after reflection of flap and degranulation, bone graft i.e., hydroxyapatite will be placed in the defect and sutures will be placed. Receives: Other: bentonite clay gel with hydroxyapatite |
What is being measured
The primary outcome is the main question the study is designed to answer.
RVG
- Radiovisiography will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.
Measured: baseline , 3months,6months
probing depth
- Assessment of probing depth using probe at baseline and postoperatively at 3 and 6 months
Measured: baseline , 3months,6months
clinical attachment level
Assessment of clinical attachment level using probe at baseline and post operatively at 3 and 6 months.
Measured: baseline , 3months,6months
Secondary outcomes (1)
1. Assessment of plaque - according to Turesky modification of Quigley and Hein Plaque Index, 1970. 2. Assessment of Gingivitis - according to Loe H and Silness P, 1963.
- Assessment of plaque - according to Turesky modification of Quigley and Hein Plaque Index, 1970.
- Assessment of Gingivitis - according to Loe H and Silness P, 1963.
Measured: baseline ,3months,6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start3 May 2023
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr R Viswa Chandra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr R Viswa Chandra, SVS Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439264
- Sponsor's protocol ID
- SVSInstituteDS
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Clinical Efficacy of Bentonite Clay Gel on Bone Regeneration in the Treatment of Intra-bony Defects: A Clinico-radiograph Study
- ClinicalTrials.gov ID
- NCT06439264
- Acronym / sponsor ID
- SVSInstituteDS
- Conditions
- Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dr R Viswa ChandraUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 3 Jun 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 aim of this study is to evaluate osseous regeneration efficacy of bentonite gel with hydroxyapatite in comparison with hydroxyapatite incase of intrabony defects
The test group includes patients with intrabony defects where flap surgery is will be performed and bentonite clay gel with HA will be placed and in control group only HA is placed.
Detailed description
Experimental: Main treatment group bentonite with hydroxyaatite is added into the defect site.
Comparator: In patients allocated to control group,only hydroxyapatite is added.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Other: bentonite clay gel with hydroxyapatiteIn test group, after reflection of flap and degranulation, bone graft i.e., bentonite clay gel with hydroxyapatite will be placed in the void created by the defect and sutures will be placed |
| control group | Active comparator | Other: bentonite clay gel with hydroxyapatiteIn control group, after reflection of flap and degranulation, bone graft i.e., hydroxyapatite will be placed in the defect and sutures will be placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Systemically healthy male and female patients of age >18 years
- two-walled or three-walled intrabony defects and
- probing pocket depths (PPD) of ≥ 5mm.
Key exclusion criteria (5 listed)
- Medically compromised patients,
- patients <18 years of age,
- pregnant women,
- heavy smokers, and
- patients who underwent radiotherapy or chemotherapy are 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 |
|---|---|---|
| bentonite clay gel with hydroxyapatitebentonite clay gel presents great potential for bone healing and it leads to the formation of interconnected microporous structure, which can promote native cell infiltration, proliferation, | Other | control group, test group |
Primary outcome
RVG
Time frame: baseline , 3months,6months
1. Radiovisiography will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.
probing depth
Time frame: baseline , 3months,6months
2. Assessment of probing depth using probe at baseline and postoperatively at 3 and 6 months
clinical attachment level
Time frame: baseline , 3months,6months
Assessment of clinical attachment level using probe at baseline and post operatively at 3 and 6 months.
1 secondary outcome
1. Assessment of plaque - according to Turesky modification of Quigley and Hein Plaque Index, 1970. 2. Assessment of Gingivitis - according to Loe H and Silness P, 1963.
Time frame: baseline ,3months,6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Bone Regeneration
Not yet recruitingPhase 2
Melatonin in Posterior Mandible Extraction Socket
Bone Loss
Recruiting
Alveolar Bone Regeneration Using Advanced Platelet-Rich Fibrin Combined With Strontium-Doped Hydroxyapatite
Alveolar Bone Regeneration, Advanced Platelet-Rich Fibrin
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruiting
Clinical Efficacy Assessment of Digitally Fabricated PEEK Barrier Membranes for Guided Bone Regeneration in Severe Bone Defects
Guided Bone Regeneration
Not yet recruitingObservational study
Impact of Gingival Phenotype on Guided Bone Regeneration in the Maxillary Anterior Region
Guided Bone Regeneration
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 bentonite clay gel with hydroxyapatite in people with Bone Regeneration, run by Dr R Viswa Chandra 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 3 inclusion and 5 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 3 Jun 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 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. 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 Dr.viswa chandra MDS (9912161007, viswachandra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RVG (time frame: baseline , 3months,6months). 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 3 Jun 2024.