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Completed

NCT Number: NCT03311906

Evaluation of the Efficacy of 0.8% Hyaluronic Acid Gel

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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, AlRiyadh, 11681, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.8% Hyaluronic Acid

Drug

Application of 0.8% hyaluronic acid after scaling and root planing

Other names: Gengigel

Scaling and Root Planing

Procedure

Scaling of the teeth using hand and ultrasonic scalers followed by planing of the root with curettes

Primary outcomes

  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 outcomes

  1. HBD-2 change

    Time frame: baseline, six weeks, 12 weeks

    By take gingival crevicular fluid sample elisa test

Sponsors and collaborators

Lead sponsor

Riyadh Colleges of Dentistry and Pharmacy

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2017
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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