Clincosm LogoSign in Get a demo

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

Sponsor
University of Sharjah (Other)
Overall Status
Recruiting
CT.gov ID
NCT05682833
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
20.6
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 .

Condition or Disease Intervention/Treatment Phase
  • Procedure: Non surgical periodontal therapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Split mouth RCTSplit mouth RCT
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of Periodontitis: A Split Mouth Randomized Controlled Trial
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Dec 20, 2023
Anticipated Study Completion Date :
Jun 20, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. pocket depth [2 months]

  2. Bleeding on Probing [2 months]

  3. Clinical attachment level [2 months]

Secondary Outcome Measures

  1. Plaque index [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Dental Hospital Sharjah Sharjah United Arab Emirates

Sponsors and Collaborators

  • University of Sharjah

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zahi BADRAN, Professor, University of Sharjah
ClinicalTrials.gov Identifier:
NCT05682833
Other Study ID Numbers:
  • REC-22-02-26-S
First Posted:
Jan 12, 2023
Last Update Posted:
Jan 12, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Periodontitis

Study Results

No Results Posted as of Jan 12, 2023