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Clinical and Immunological Evaluation of HA in Treatment of Periodontitis

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06324474
Enrollment
24
Registered
2024-03-22
Start date
2025-04-30
Completion date
2025-12-12
Last updated
2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Brief summary

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.

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.

Interventions

DRUGHyaluronic acid

Gengigel syringe containing 1ml of 0.8% HA

scaling and root planning using ultrasonic scaler

Sponsors

Sana'a University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in Plaque IndexFrom Baseline to 12th weeks post intervention '' changes from baseline to 12th weekranges from 0 to 3 score, where increasing in number indicates the worst case.
Changes in Gingival IndexFrom Baseline to 12th weeks post intervention '' changes from baseline to 12th weekRanges from 0 to 3 stages, where increasing in number indicates the worst case.
Changes in Papillary Bleeding Index.From Baseline to 12th weeks post intervention '' changes from baseline to 12th weekRanges from 0 to 4 score, where increasing in number indicates the worst case
Periodontal Probing DepthFrom Baseline to 12th weeks post intervention '' changes from baseline to 12th weekdistance from the gingival margin to the base of the pocket
Clinical attachment lossFrom baseline to 12th weeks post intervention changes from baseline to 12th weekDistance from cemento-enamel junction to the base of pocket
Changes in IGF-1From baseline to 12th weeks post intervention changes from baseline to 12th weekThrough gingival cervical fluid serum collection

Countries

Yemen

Contacts

Primary ContactGhada Almuqayad, BDS
Ghadamqd@gmail.com+967733855972
Backup ContactWadhah Al-haj, Ass prof
Waddah.alhaj@gmail.com+967773446446

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026