Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of Periodontitis

January 10, 2023 updated by: Zahi BADRAN, University of Sharjah

Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of Periodontitis: A Split Mouth Randomized Controlled Trial

General Objective :

To evaluate the outcome of non surgical periodontal therapy with local drug delivery adjunct to scaling and root planning

Specific Objective :

To determine the effect of intra-pocket application of hyaluronic acid /chlorohexidine gel in non surgical periodontal treatment on clinical periodontal parameters and microbiological level .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

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

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age : 20-60 years old
  • At least 20 remaining teeth
  • Periodontitis stage III and IV ,Grade A, B and C

Exclusion Criteria:

  • Patients taking specific medications: antibiotic , anticoagulants or anti-inflammatory
  • Previous periodontal therapy in the past 3-6 months.
  • Immunocompromised patients
  • Systemically diseased patients: Diabetes ,osteoporosis etc
  • History of allergies or hypersensitivity reactions to chlorohexidine or Hyaluronic acid
  • Pregnant or lactating women.
  • Heavy Smokers (more than 20/day)

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
NS therapy + Chlorhexidine/Hyaluronic acid subgingival gel application
Procedure: Non surgical periodontal therapy
Subgingival ultrasonic debridement + manual root planning
Placebo Comparator: Control
NS therapy + Placebo gel subgingival application
Procedure: Non surgical periodontal therapy
Subgingival ultrasonic debridement + manual root planning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pocket depth
Time Frame: 2 months
2 months
Bleeding on Probing
Time Frame: 2 months
2 months
Clinical attachment level
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Plaque index
Time Frame: 2 months
2 months

Collaborators and Investigators

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

Sponsor

University of Sharjah

Investigators

  • Study Director: Zahi BADRAN, Phd, University of Sharjah

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)

October 1, 2022

Primary Completion (Anticipated)

December 20, 2023

Study Completion (Anticipated)

June 20, 2024

Study Registration Dates

First Submitted

December 28, 2022

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-22-02-26-S

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.

Clinical Trials on Periodontitis

Clinical Trials on Non surgical periodontal therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe