Evaluation of the Efficacy of 0.8% Hyaluronic Acid Gel

March 1, 2018 updated by: Nour Al Shammari, Riyadh Colleges of Dentistry and Pharmacy

Clinical and Laboratory Effect of 0.8% Hyaluronic Acid Gel in Conventional Treatment of Moderate to Severe Chronic Periodontitis

assess the clinical and laboratory effects of the local and sub gingival application of a 0.8% hyaluronic acid gel (GENGIGEL®) as an adjunct to scaling and root planning (SRP) in chronic moderate to severe periodontitis patients as indicated by expression of Human Beta Definsin-2 (HBD2) in gingival crevicular fluid (GCF).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who fulfilled the selection criteria will be included in the study. One quadrant will be treated with HA gel (test) and the other without to serve as control. Clinical examination will be done in a dental chair under standard conditions of light, using mouth mirror and graduated Williams Periodontal Probe.

All patients will receive full mouth scaling and root planing with hand instruments and ultrasonic scalers at baseline. Thereafter, in the test quadrant, 1 ml of 0.8% hyaluronic acid gel will be administered subgingivally in all selected test sites at baseline and 1 week later. The following clinical parameters will be recorded at baseline, after 6 weeks and 12 weeks post treatment. Oral hygiene instructions will be given to all patients. The clinical measurements and treatment will be performed by a single examiner.For every patient and control subject, GCF samples will be collected at baseline, 6 weeks and 12 weeks post treatment. The samples will be pooled from two periodontal sites with clinical attachment level of 3 mm or more (in the two different quadrants). The sampling area will be isolated with cotton rolls and carefully will be cleaned supragingivally with sterile cotton pellets. A sterile absorbent paper point will be inserted into the gingival crevice or pocket until resistance will be felt. The paper point will be held in place for 30 s and then will be transferred to a vial containing 100 μL of distilled water and vigorously will be mixed. The paper points will be removed, and the samples will be centrifuged and will be washed twice with distilled water. The resultant pellets will be resuspended in 0.4 mL of distilled water. The samples will be coded and stored at -70 °C until use for ELISA test for identification of Human beta Defensin-2.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • AlRiyadh
      • Riyadh, AlRiyadh, Saudi Arabia, 11681
        • Riyadh Colleges of Dentistry and Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients should be systemically healthy with moderate to severe chronic periodontitis of more than 4 mm probing depth in at least two sites in different quadrants.
  • Patient should exhibit no known allergies
  • Participants should have the ability to attend the hospital regular intervals.

Exclusion Criteria:

  • pregnancy
  • nursing
  • hypertension
  • patient with chronic diseases such as diabetes mellitus or rheumatoid arthritis. -Participants should not be under antibiotics and\or had receive any periodontal therapy for the last 6 months.
  • Participants should not taking drugs that could affect the state of the gingival tissues.
  • Participants must not be undergoing orthodontic therapy, caries free
  • Participants must not be using any other supplemental plaque control measures like mouthwashes.
  • Participants should not have the habit of taking alcohol, smoking or chewing tobacco and do not suffer from any systemic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test side
Scaling and Root Planing 0.8% Hyaluronic acid gel
Drug: 0.8% Hyaluronic Acid
Application of 0.8% hyaluronic acid after scaling and root planing
Other Names:
  • Gengigel
Procedure: Scaling and Root Planing
Scaling of the teeth using hand and ultrasonic scalers followed by planing of the root with curettes
Active Comparator: Control Side
Scaling and Root Planing
Procedure: Scaling and Root Planing
Scaling of the teeth using hand and ultrasonic scalers followed by planing of the root with curettes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Attachment Level (CAL) change
Time Frame: baseline, six weeks, 12 weeks
Distance from the cementoenamel junction to the base of gingival sulcus using a UNC15 probe
baseline, six weeks, 12 weeks
Probing Depth change
Time Frame: baseline, six weeks, 12 weeks
It's the distance from the gingival margin to base of the sulcus
baseline, six weeks, 12 weeks
Gingival Index change (Loe and Silness, 1963)
Time Frame: baseline, six weeks, 12 weeks
To assess the gingival condition and record qualitative chances in the gingiva
baseline, six weeks, 12 weeks
Plaque index change (Loe and Silness, 1964)
Time Frame: baseline, six weeks, 12 weeks
To measure the state of oral hygiene
baseline, six weeks, 12 weeks
Papillary Bleeding Index change (Muhlemann, 1977)
Time Frame: baseline, six weeks, 12 weeks
immediate evaluation of the patient's gingival motivation and condition
baseline, six weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBD-2 change
Time Frame: baseline, six weeks, 12 weeks
By take gingival crevicular fluid sample elisa test
baseline, six weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riyadh Colleges of Dentistry and Pharmacy

Investigators

  • Study Director: Sanaa M Shafshak, PhD, Riyadh Colleges of Dentistry and Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2017

Primary Completion (Actual)

August 15, 2017

Study Completion (Actual)

October 2, 2017

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 15, 2017

First Posted (Actual)

October 17, 2017

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPGRP/43631003/73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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