Clinical and Immunological Evaluation of HA in Treatment of Periodontitis

December 3, 2024 updated by: ghada almuqayad, Sana'a University

Clinical and Immunological Evaluation of Hyaluronic Acid Topical Application in Non-surgical Treatment of Periodontitis

To evaluate the immunological effectiveness of Hyaluronic acid as adjunction treatment to scaling and root planning and scaling and root planning alone.

Comparison between clinical measurement before and after treatment. Evaluate the level of IGF-1 in treated site as immunological marker if periodontal regeneration.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Periodontal tissue represents a unique system, where the epithelial, non- mineralized, and mineralized connective tissues exist in harmony. This integrity is essential in providing an effective barrier against microbial invasion and preventing the destruction of underlying periodontal tissues by bacterial toxins and enzymes. However; it may lose during chronic inflammation associated with periodontal disease leading to detrimental effects upon the extracellular matrix components of underlying periodontal tissues, including collagens, proteoglycans, and glycosaminoglycans.

Periodontitis is a chronic multifactorial inflammatory disease associated with plaque biofilms and characterized by progressive destruction of the tooth- supporting apparatus. It is considered as an inflammatory condition of the periodontium, which includes an immune response and results in loss of supporting tissues of the teeth. It may affect the general health; a combination of mechanical and chemical treatment provides a good recovery. The etiology for this disease is the accumulation of bacterial plaque on the tooth surface that leads to marginal tissue inflammation, known as gingivitis which is reversable condition that may develop to periodontitis if not treated. ( A new periodontitis scheme has been adopted in which forms of disease previously recognized as 'chronic' or 'aggressive' are now grouped under a single category 'periodontitis' and are further characterized based on a multi-dimensional staging and grading system. Staging is largely dependent upon the severity of disease at presentation as well as on the complexity of disease management, while grading provides supplemental information about biological feature of the disease.

However, the final success rate of the treatment depends on the status and maintenance of oral hygiene. Signs and symptoms of periodontitis may include redness, swelling bleeding of gum, loss of attachment, halitosis and persistent metallic taste in the mouth.

Antibiotics are mandatory in some cases, systemic antibiotics somewhat are effective, no single antibiotic at concentrations achieved in body fluids inhibits all putative periodontal pathogens, indeed a combination of antibiotics may be necessary to eliminate all putative pathogen from some periodontal pockets. ( Topical application has the advantage that antibiotic agents are directed to their specific target areas; reduced drug dosage, increased drug concentration, and reduced side effects can be benefits of topical application. Unfortunately, some antibiotics when used topically induce superinfection and hypersensitivity reaction.

Hyaluronic acid (HA) is an indispensable component of intact, healthy gingiva, and oral mucosal tissue. It has many properties that make it ideal molecule for assisting wound healing by inducing early granulation tissue formation, inhibiting inflammation, promoting epithelial turnover, and also connective tissue angiogenesis. It has many important physiological and biological functions and plays a vital role in the functioning of extracellular matrix including those of periodontium.

Its application as adjunct to non-surgical periodontal treatment seems to have a beneficial effect on surrogate outcome variables of periodontal inflammation, thus; its emerging as a boon prospect in treatment of periodontitis.

Jain Y. proved on a research done on 2013 that 0.2% HA was effective agent on plaque induced gingivitis as an adjunct to scaling as compared to scaling alone, however; a study was done in 2015 in sub-gingival placement of 0.2 ml of 0.8% of HA along with scaling and root planning (SRP) had a significant improvement in both clinical and microbiological parameters when compared with the control site.

Gingival cervical fluid (GCF) is a physiological fluid as well as an inflammatory exudate originating from the gingival plexus of blood vessels in the gingival corium, subjacent to the epithelium lining of the dento-gingival space, Collection of GCF is non-invasive there for this approach has been extensively explored in the search for potential diagnostic biomarker of periodontal disease. Numerous cytokines are released from cells of the sulcular and junctional epithelium. Growth factors are biologically active polypeptides affecting the proliferation, chemotaxis, and differentiation of cells from epithelium, bone and connective tissue. They express their action by binding to specific cell surface receptors present on various target cells including osteoblast, cementoblast, and periodontal ligament fibroblast.

Insulin like growth factor (IGF-1) is a potent mitogenic protein which can enhance the osteogenic differentiation of periodontal ligament fibroblast.

The more the concentration of IGF-1 the more the cell proliferation as proven in a study of insulin like growth factor-1 promotes proliferation, migration and osteoblast differentiation of periodontal ligament stem cell.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Yemen
      • Sana'a, Yemen
        • Sana'a University

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • systemically healthy.
  • at least 20 teeth and suffers from moderate <7mm to severe. >8mm.periodontitis with probing depth >5m and in the contralateral side.
  • ability to attend to the clinic in a regular manner.

Exclusion Criteria:

  • allergy to HA.
  • Chronic disease.
  • orthodontic treatment.
  • Qat chewer and smokers.
  • antibiotic in previous 3 months.
  • supplements and mouthwash.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: scaling and root planning with Hyaluronic acid application
patients will receive Hyaluronic acid topical gel after scaling and root planning at first week and receive the gel after one week
Drug: Hyaluronic acid
Gengigel syringe containing 1ml of 0.8% HA
Other Names:
  • HA syringe
Behavioral: scaling and root planning
scaling and root planning using ultrasonic scaler
Experimental: scaling and root planning only
patients will receive scaling and root planning only
Behavioral: scaling and root planning
scaling and root planning using ultrasonic scaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Plaque Index
Time Frame: From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"
ranges from 0 to 3 score, where increasing in number indicates the worst case.
From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"
Changes in Gingival Index
Time Frame: From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"
Ranges from 0 to 3 stages, where increasing in number indicates the worst case.
From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"
Changes in Papillary Bleeding Index.
Time Frame: From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"
Ranges from 0 to 4 score, where increasing in number indicates the worst case
From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"
Periodontal Probing Depth
Time Frame: From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"
distance from the gingival margin to the base of the pocket
From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"
Clinical attachment loss
Time Frame: From baseline to 12th weeks post intervention "changes from baseline to 12th week
Distance from cemento-enamel junction to the base of pocket
From baseline to 12th weeks post intervention "changes from baseline to 12th week
Changes in IGF-1
Time Frame: From baseline to 12th weeks post intervention "changes from baseline to 12th week
Through gingival cervical fluid serum collection
From baseline to 12th weeks post intervention "changes from baseline to 12th week

Collaborators and Investigators

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

Sponsor

Sana'a University

Investigators

  • Principal Investigator: Ghada Almuqayad, BDS, Sana'a University

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 (Estimated)

April 1, 2025

Primary Completion (Estimated)

December 12, 2025

Study Completion (Estimated)

December 12, 2025

Study Registration Dates

First Submitted

November 25, 2023

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA treatment of periodontitis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Periodontitis

Clinical Trials on Hyaluronic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe