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

Primary Purpose

Periodontitis, Hyaluronic Acid, Chlorhexidine

Status
Recruiting
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Non surgical periodontal therapy
Sponsored by
University of Sharjah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University Dental Hospital SharjahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test

Control

Arm Description

NS therapy + Chlorhexidine/Hyaluronic acid subgingival gel application

NS therapy + Placebo gel subgingival application

Outcomes

Primary Outcome Measures

pocket depth
Bleeding on Probing
Clinical attachment level

Secondary Outcome Measures

Plaque index

Full Information

First Posted
December 28, 2022
Last Updated
January 10, 2023
Sponsor
University of Sharjah
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1. Study Identification

Unique Protocol Identification Number
NCT05682833
Brief Title
Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of Periodontitis
Official Title
Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of Periodontitis: A Split Mouth Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
June 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sharjah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Hyaluronic Acid, Chlorhexidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split mouth RCT
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
NS therapy + Chlorhexidine/Hyaluronic acid subgingival gel application
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
NS therapy + Placebo gel subgingival application
Intervention Type
Procedure
Intervention Name(s)
Non surgical periodontal therapy
Intervention Description
Subgingival ultrasonic debridement + manual root planning
Primary Outcome Measure Information:
Title
pocket depth
Time Frame
2 months
Title
Bleeding on Probing
Time Frame
2 months
Title
Clinical attachment level
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Plaque index
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Zahi Badran Prof.
Phone
+97165057353
Email
zbadran@sharjah.ac.ae
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zahi BADRAN, Phd
Organizational Affiliation
University of Sharjah
Official's Role
Study Director
Facility Information:
Facility Name
University Dental Hospital Sharjah
City
Sharjah
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zahi BADRAN
Email
zbadran@sharjah.ac.ae

12. IPD Sharing Statement

Plan to Share IPD
No

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

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