Hyaluronic Acid Mouthwash as Adjunct | NCT07366398

Studies
Hyaluronic Acid Mouthwash as Adjunct

NCT07366398

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jan 26, 2026Actual

Enrollment

16Actual

Phase

Phase 3

Conditions

Gingivitis; Chronic

Interventions

Hyaluoric acid mouthwash
Chlorhexidine 0,12%

Countries

Egypt

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 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2025Actual

Primary Completion Date

May 30, 2025Actual

Completion Date

May 30, 2025Actual

First Submitted Date

Jan 17, 2026

First Submission Date that Met QC Criteria

Jan 23, 2026

First Posted Date

Jan 26, 2026Actual

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 23, 2026

Last Update Posted Date

Jan 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Patients were instructed to use 2 different mouthwashes after performing professional tooth cleaning. The effect of each of the 2 mouthwashes was detected.

Detailed Description

The study tests the efficacy of hyaluronic acid (HYL) mouthwash as adjunct to Chlorhexidine (CHX) mouthwash compared to Chlorhexidine mouthwash only in 16 gingivitis patients. Patients were randomly assigned to either control group received (Chlorhexidine mouthwash) or test group received (hyaluronic acid + Chlorhexidine mouthwash). Clinical parameters and patient reported outcomes as post-operative questionnaire were assessed at baseline and seven days post-operatively.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chlorhexidine mouthwash	Active Comparator		Drug: Chlorhexidine 0,12%
Hyaluronic acid + Chlorhexidine mouthwash	Active Comparator		Drug: Hyaluoric acid mouthwash Drug: Chlorhexidine 0,12%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyaluoric acid mouthwash	Drug	A mouthwash containing both hyaluronic acid	Hyaluronic acid + Chlorhexidine mouthwash

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bleeding on probing	% of gingival sites where bleeding occurred on periodontal probing is registered out of total gingival sites	7 days

Secondary Outcomes

Measure	Description	Time Frame
Plaque index	% of gingival sites where plaque accumulates is registered out of total gingival sites	7 days
Patient's satisfaction questionnaire		7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with gingivitis

Exclusion Criteria:

pregnant or lactating females and current smokers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis
D000092122	Bronchiolitis Obliterans Syndrome

Ancestor Terms

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided