Gingival DestructionNCT06447311
Assessing the Clinical Efficacy of Hyaluronic Acid Hydrogel in Papilla Augmentation: A Clinical Study.
A study testing Hyaluronic acid gel in people with Gingival Destruction, run by Dr R Viswa Chandra at 1 site in India.
Trial summary
The aim of this study is to evaluate the effect of hyaluronic acid gel in papilla augmentation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Destruction
- What is being tested?
- Hyaluronic acid gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 10 Apr 2023to Jun 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
- Non-smoking patients aged above 18 years.
- Have at least one site with interdental papilla recession in the anterior region (central incisors, lateral incisors and canines) of the maxillary or mandibular jaws.
- Class I or Class II papillary recession.
- The distance from the contact point to alveolar bone crest ≥5mm.
- No active periodontal diseases and good oral hygiene.
Who cannot join
- spacing or crowding between the teeth to be treated,
- abnormal tooth shape,
- systemic diseases such as diabetes mellitus, hypertension or
- conditions that alter the outcome of periodontal therapy.
- Pregnant and lactating women and
- tobacco users
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
SVS Institute of dental sciences
Mahbūbnagar, Telangana, 509002
VISWA CHANDRA, MDS;DNB;PhD, 9908183071, rampalliviswa@gmail.com
About this study
The aim of this study is to evaluate the effect of hyaluronic acid gel in papilla augmentation.
Read the detailed description
Assessing the clinical efficacy of Hyaluronic acid hydrogel in papilla augmentation: A clinical study.
In Test group, Hyaluronic acid hydrogel will be injected using a syringe into the interdental papillary deficiency site.
In Control group, saline placebo gel will be injected into the interdental papillary deficiency site using a syringe.
- Conditions
- Gingival Destruction
- Being tested
- Hyaluronic acid gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid gelOther
Hyaluronic acid is involved in tissue repair and wound healing by stimulating cell proliferation, migration and interaction with several growth factors. Furthermore, HA has a crucial role in space-filling owing to its hygroscopic nature.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | In Test group, the prepared Hyaluronic acid gel will be injected using a syringe into the defect site. Receives: Other: Hyaluronic acid gel |
| Control group | Placebo comparator | In Control group, saline placebo gel will be injected into the defect site using a syringe. Receives: Other: Hyaluronic acid gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of papilla augmentation
Assessment of the empty space left by the receding interdental papilla will be measured using UNC-15 probe at baseline and post-operatively at 3 and 6 months.
Measured: Baseline to 6 months
Secondary outcomes (2)
Assessment of plaque
Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index, 1970
Measured: baseline ,3months,6months
Assessment of gingiva
Gingival index (GI) - 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 posted7 Jun 2024
- Study start10 Apr 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival DestructionStudies 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
- NCT06447311
- Sponsor's protocol ID
- SVSInstituteDS4
- Status last verified
- Jun 2024
- First submitted
- 20 May 2024
- Last updated
- 7 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 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Clinical Efficacy of Hyaluronic Acid Hydrogel in Papilla Augmentation: A Clinical Study.
- ClinicalTrials.gov ID
- NCT06447311
- Acronym / sponsor ID
- SVSInstituteDS4
- Conditions
- Gingival Destruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dr R Viswa ChandraUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 7 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 the effect of hyaluronic acid gel in papilla augmentation.
Detailed description
Assessing the clinical efficacy of Hyaluronic acid hydrogel in papilla augmentation: A clinical study.
In Test group, Hyaluronic acid hydrogel will be injected using a syringe into the interdental papillary deficiency site.
In Control group, saline placebo gel will be injected into the interdental papillary deficiency site using a syringe.
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: Hyaluronic acid gelIn Test group, the prepared Hyaluronic acid gel will be injected using a syringe into the defect site. |
| Control group | Placebo comparator | Other: Hyaluronic acid gelIn Control group, saline placebo gel will be injected into the defect site using a syringe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-smoking patients aged above 18 years.
- Have at least one site with interdental papilla recession in the anterior region (central incisors, lateral incisors and canines) of the maxillary or mandibular jaws.
- Class I or Class II papillary recession.
- The distance from the contact point to alveolar bone crest ≥5mm.
- No active periodontal diseases and good oral hygiene.
Key exclusion criteria (6 listed)
- spacing or crowding between the teeth to be treated,
- abnormal tooth shape,
- systemic diseases such as diabetes mellitus, hypertension or
- conditions that alter the outcome of periodontal therapy.
- Pregnant and lactating women and
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 |
|---|---|---|
| Hyaluronic acid gelHyaluronic acid is involved in tissue repair and wound healing by stimulating cell proliferation, migration and interaction with several growth factors. Furthermore, HA has a crucial role in space-filling owing to its hygroscopic nature. | Other | Control group, Test group |
Primary outcome
Evaluation of papilla augmentation
Time frame: Baseline to 6 months
Assessment of the empty space left by the receding interdental papilla will be measured using UNC-15 probe at baseline and post-operatively at 3 and 6 months.
2 secondary outcomes
Assessment of plaque
Time frame: baseline ,3months,6months
Assessment of gingiva
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 7 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid gel in people with Gingival Destruction, 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 5 inclusion and 6 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 7 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. 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 Dr.viswa chandra, MDS (8897819848, 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 papilla augmentation (time frame: Baseline to 6 months). 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 7 Jun 2024.