Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine G... | NCT05682833

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

NCT05682833

Sponsor

University of Sharjah

Status

Unknown status

Last Update Posted

Jan 12, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Periodontitis
Hyaluronic Acid
Chlorhexidine

Interventions

Non surgical periodontal therapy

Countries

United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Dec 20, 2023Estimated

Completion Date

Jun 20, 2024Estimated

First Submitted Date

Dec 28, 2022

First Submission Date that Met QC Criteria

Jan 10, 2023

First Posted Date

Jan 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2023

Last Update Posted Date

Jan 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test	Experimental	NS therapy + Chlorhexidine/Hyaluronic acid subgingival gel application	Procedure: Non surgical periodontal therapy
Control	Placebo Comparator	NS therapy + Placebo gel subgingival application	Procedure: Non surgical periodontal therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non surgical periodontal therapy	Procedure	Subgingival ultrasonic debridement + manual root planning	Control Test

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Plaque index		2 months

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Prof. Zahi Badran Prof.	Contact	+97165057353		zbadran@sharjah.ac.ae

Overall Officials

Name	Affiliation	Role
Zahi BADRAN, Phd	University of Sharjah	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Dental Hospital Sharjah	Recruiting	Sharjah city			United Arab Emirates

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010518	Periodontitis

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided