Clinical and Immunological Evaluation of HA in Treatment of Periodontitis
- Conditions
- Periodontitis
- Interventions
- Behavioral: scaling and root planning
- Registration Number
- NCT06324474
- Lead Sponsor
- Sana'a University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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.
- allergy to HA.
- Chronic disease.
- orthodontic treatment.
- Qat chewer and smokers.
- antibiotic in previous 3 months.
- supplements and mouthwash.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description scaling and root planning with Hyaluronic acid application scaling and root planning patients will receive Hyaluronic acid topical gel after scaling and root planning at first week and receive the gel after one week scaling and root planning with Hyaluronic acid application Hyaluronic acid patients will receive Hyaluronic acid topical gel after scaling and root planning at first week and receive the gel after one week scaling and root planning only scaling and root planning patients will receive scaling and root planning only
- Primary Outcome Measures
Name Time Method Changes in Plaque Index 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.
Changes in Papillary Bleeding Index. 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
Changes in Gingival Index 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.
Changes in IGF-1 From baseline to 12th weeks post intervention "changes from baseline to 12th week Through gingival cervical fluid serum collection
Periodontal Probing Depth From Baseline to 12th weeks post intervention '' changes from baseline to 12th week" distance from the gingival margin to the base of the pocket
Clinical attachment loss From baseline to 12th weeks post intervention "changes from baseline to 12th week Distance from cemento-enamel junction to the base of pocket
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sana'a university
🇾🇪Sana'a, Yemen