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Evaluation of the Efficacy of 0.8% Hyaluronic Acid Gel

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
0.8% Hyaluronic Acid
Scaling and Root Planing
Sponsored by
Riyadh Colleges of Dentistry and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Riyadh Colleges of Dentistry and Pharmacy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test side

Control Side

Arm Description

Scaling and Root Planing 0.8% Hyaluronic acid gel

Scaling and Root Planing

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HBD-2 change
By take gingival crevicular fluid sample elisa test

Full Information

First Posted
October 2, 2017
Last Updated
March 1, 2018
Sponsor
Riyadh Colleges of Dentistry and Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT03311906
Brief Title
Evaluation of the Efficacy of 0.8% Hyaluronic Acid Gel
Official Title
Clinical and Laboratory Effect of 0.8% Hyaluronic Acid Gel in Conventional Treatment of Moderate to Severe Chronic Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
August 15, 2017 (Actual)
Study Completion Date
October 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riyadh Colleges of Dentistry and Pharmacy

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
A split mouth study design is used where all participants receive both interventions
Masking
ParticipantOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test side
Arm Type
Experimental
Arm Description
Scaling and Root Planing 0.8% Hyaluronic acid gel
Arm Title
Control Side
Arm Type
Active Comparator
Arm Description
Scaling and Root Planing
Intervention Type
Drug
Intervention Name(s)
0.8% Hyaluronic Acid
Other Intervention Name(s)
Gengigel
Intervention Description
Application of 0.8% hyaluronic acid after scaling and root planing
Intervention Type
Procedure
Intervention Name(s)
Scaling and Root Planing
Intervention Description
Scaling of the teeth using hand and ultrasonic scalers followed by planing of the root with curettes
Primary Outcome Measure Information:
Title
Clinical Attachment Level (CAL) change
Description
Distance from the cementoenamel junction to the base of gingival sulcus using a UNC15 probe
Time Frame
baseline, six weeks, 12 weeks
Title
Probing Depth change
Description
It's the distance from the gingival margin to base of the sulcus
Time Frame
baseline, six weeks, 12 weeks
Title
Gingival Index change (Loe and Silness, 1963)
Description
To assess the gingival condition and record qualitative chances in the gingiva
Time Frame
baseline, six weeks, 12 weeks
Title
Plaque index change (Loe and Silness, 1964)
Description
To measure the state of oral hygiene
Time Frame
baseline, six weeks, 12 weeks
Title
Papillary Bleeding Index change (Muhlemann, 1977)
Description
immediate evaluation of the patient's gingival motivation and condition
Time Frame
baseline, six weeks, 12 weeks
Secondary Outcome Measure Information:
Title
HBD-2 change
Description
By take gingival crevicular fluid sample elisa test
Time Frame
baseline, six weeks, 12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanaa M Shafshak, PhD
Organizational Affiliation
Riyadh Colleges of Dentistry and Pharmacy
Official's Role
Study Director
Facility Information:
Facility Name
Riyadh Colleges of Dentistry and Pharmacy
City
Riyadh
State/Province
AlRiyadh
ZIP/Postal Code
11681
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
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Evaluation of the Efficacy of 0.8% Hyaluronic Acid Gel

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