NCT06447311

Brief Summary

The aim of this study is to evaluate the effect of hyaluronic acid gel in papilla augmentation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2024

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

1.1 years

First QC Date

May 20, 2024

Last Update Submit

June 1, 2024

Conditions

Gingival Destruction

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 6 months

Secondary Outcomes (2)

  • Assessment of plaque

    baseline ,3months,6months

  • Assessment of gingiva

    baseline ,3months,6months

Study Arms (2)

Test group

EXPERIMENTAL

In Test group, the prepared Hyaluronic acid gel will be injected using a syringe into the defect site.

Other: Hyaluronic acid gel

Control group

PLACEBO COMPARATOR

In Control group, saline placebo gel will be injected into the defect site using a syringe.

Other: Hyaluronic acid gel

Interventions

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.

Control groupTest group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SVS Institute of dental sciences

Mahbūbnagar, Telangana, 509002, India

RECRUITING

Central Study Contacts

Dr.viswa chandra, MDS

CONTACT

8897819848viswachandra@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PROFFESSOR AND HEAD OF THE DEPARTMENT

Study Record Dates

First Submitted

May 20, 2024

First Posted

June 7, 2024

Study Start

April 10, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

June 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)