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

Not Applicable

Recruiting

• Conditions: Gingival Destruction
• Interventions: Other: Hyaluronic acid gel

• Registration Number: NCT06447311
• Lead Sponsor: Dr R Viswa Chandra

Brief Summary

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 Timeline

• Study Start: 2023-04-10
• Study First Submitted: 2024-05-20
• Status Verified: 2024-06
• Primary Completion: 2024-06
• Study Completion: 2024-06
• Study First Submitted QC: 2024-06-01
• Last Update Submitted: 2024-06-01
• Study First Posted: 2024-06-07
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Hyaluronic acid gel	In Test group, the prepared Hyaluronic acid gel will be injected using a syringe into the defect site.
Control group	Hyaluronic acid gel	In Control group, saline placebo gel will be injected into the defect site using a syringe.

Primary Outcome Measures

Name	Time	Method
Evaluation of papilla augmentation	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

SVS Institute of dental sciences; 🇮🇳 Mahbubnagar, Telangana, India