Assessing the Clinical Efficacy of Hyaluronic Acid Hydrogel in Papilla Augmentation: A Clinical Study.

June 1, 2024 updated by: Dr R Viswa Chandra
The aim of this study is to evaluate the effect of hyaluronic acid gel in papilla augmentation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Telangana
      • Mahbubnagar, Telangana, India, 509002
        • Recruiting
        • Svs Institute of Dental Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Non-smoking patients aged above 18 years.
  2. 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.
  3. Class I or Class II papillary recession.
  4. The distance from the contact point to alveolar bone crest ≥5mm.
  5. No active periodontal diseases and good oral hygiene.

Exclusion Criteria:

  1. spacing or crowding between the teeth to be treated,
  2. abnormal tooth shape,
  3. systemic diseases such as diabetes mellitus, hypertension or
  4. conditions that alter the outcome of periodontal therapy.
  5. Pregnant and lactating women and
  6. tobacco users

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group
In Test group, the prepared Hyaluronic acid gel will be injected using a syringe into the defect site.
Other: Hyaluronic acid gel
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.
Placebo Comparator: Control group
In Control group, saline placebo gel will be injected into the defect site using a syringe.
Other: Hyaluronic acid gel
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of plaque
Time Frame: baseline ,3months,6months
Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index, 1970
baseline ,3months,6months
Assessment of gingiva
Time Frame: baseline ,3months,6months
Gingival index (GI) - according to Loe H and Silness P, 1963
baseline ,3months,6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr R Viswa Chandra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 20, 2024

First Submitted That Met QC Criteria

June 1, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 1, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVSInstituteDS4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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