NCT05682833

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

December 28, 2022

Last Update Submit

January 10, 2023

Conditions

PeriodontitisHyaluronic AcidChlorhexidine

Outcome Measures

Primary Outcomes (3)

  • pocket depth

    2 months

  • Bleeding on Probing

    2 months

  • Clinical attachment level

    2 months

Secondary Outcomes (1)

  • Plaque index

    2 months

Study Arms (2)

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

Non surgical periodontal therapyPROCEDURE

Subgingival ultrasonic debridement + manual root planning

ControlTest

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age : 20-60 years old
  • At least 20 remaining teeth
  • Periodontitis stage III and IV ,Grade A, B and C

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Dental Hospital Sharjah

Sharjah city, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Zahi BADRAN, Phd

    University of Sharjah

    STUDY DIRECTOR

Central Study Contacts

Prof. Zahi Badran Prof.

CONTACT

+97165057353zbadran@sharjah.ac.ae

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Split mouth RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 28, 2022

First Posted

January 12, 2023

Study Start

October 1, 2022

Primary Completion

December 20, 2023

Study Completion

June 20, 2024

Last Updated

January 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

AE(1)