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Evaluation of the Efficacy of 0.8% Hyaluronic Acid Gel

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ClinicalTrials.gov Identifier: NCT03311906
Recruitment Status : Completed
First Posted : October 17, 2017
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Nour Al Shammari, Riyadh Colleges of Dentistry and Pharmacy

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).

Condition or disease Intervention/treatment Phase
Periodontitis Drug: 0.8% Hyaluronic Acid Procedure: Scaling and Root Planing Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A split mouth study design is used where all participants receive both interventions
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: Clinical and Laboratory Effect of 0.8% Hyaluronic Acid Gel in Conventional Treatment of Moderate to Severe Chronic Periodontitis
Actual Study Start Date : February 15, 2017
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : October 2, 2017

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. 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

  2. Probing Depth change [ Time Frame: baseline, six weeks, 12 weeks ]
    It's the distance from the gingival margin to base of the sulcus

  3. 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

  4. Plaque index change (Loe and Silness, 1964) [ Time Frame: baseline, six weeks, 12 weeks ]
    To measure the state of oral hygiene

  5. Papillary Bleeding Index change (Muhlemann, 1977) [ Time Frame: baseline, six weeks, 12 weeks ]
    immediate evaluation of the patient's gingival motivation and condition


Secondary Outcome Measures :
  1. HBD-2 change [ Time Frame: baseline, six weeks, 12 weeks ]
    By take gingival crevicular fluid sample elisa test



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311906


Locations
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Saudi Arabia
Riyadh Colleges of Dentistry and Pharmacy
Riyadh, AlRiyadh, Saudi Arabia, 11681
Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy
Investigators
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Study Director: Sanaa M Shafshak, PhD Riyadh Colleges of Dentistry and Pharmacy

Publications of Results:

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Responsible Party: Nour Al Shammari, Senior Resident, Riyadh Colleges of Dentistry and Pharmacy
ClinicalTrials.gov Identifier: NCT03311906     History of Changes
Other Study ID Numbers: FPGRP/43631003/73
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents