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

NCT ID: NCT05682833

Last Updated: 2023-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-06-20

Brief Summary

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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

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Conditions

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Periodontitis Hyaluronic Acid Chlorhexidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split mouth RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Test

NS therapy + Chlorhexidine/Hyaluronic acid subgingival gel application

Group Type EXPERIMENTAL

Non surgical periodontal therapy

Intervention Type PROCEDURE

Subgingival ultrasonic debridement + manual root planning

Control

NS therapy + Placebo gel subgingival application

Group Type PLACEBO_COMPARATOR

Non surgical periodontal therapy

Intervention Type PROCEDURE

Subgingival ultrasonic debridement + manual root planning

Interventions

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Non surgical periodontal therapy

Subgingival ultrasonic debridement + manual root planning

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sharjah

OTHER

Sponsor Role lead

Responsible Party

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Zahi BADRAN

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zahi BADRAN, Phd

Role: STUDY_DIRECTOR

University of Sharjah

Locations

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University Dental Hospital Sharjah

Sharjah city, , United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Central Contacts

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Prof. Zahi Badran Prof.

Role: CONTACT

+97165057353

Facility Contacts

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Zahi BADRAN

Role: primary

Other Identifiers

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REC-22-02-26-S

Identifier Type: -

Identifier Source: org_study_id

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