Application of Hyaluronic Acid in Diabetes

Study Overview
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Brief Summary
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sub gingival application of hyaluronic acid create great clinical improvement of periodontal pocket treatment.

Detailed Description
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To clinically and radiographically evaluate the adjunctive effect of the local application of a 0.8% hyaluronan gel in addition to scaling and root planing in treatment of controlled diabetic patients with stage II periodontitis.

Official Title
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Evaluation of The Clinical & Radiographic Parameters in Controlled Type 2 Diabetic Patients Treated With Non-Surgical Periodontal Therapy With & Without Using Hyaluronic Acid Gel

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Drug: Hyaluronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Patient with controlled diabetic type 2 (HgA1C <7) (Mori et al., 2021). Periodontitis stage II. Periodontitis grade B. Pocket depth > 4 mm. Smoking ≤ 10 cigarettes/day. Cooperative patients able and accept to come for follow up appointments Exclusion Criteria: • The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 6 months of follow-up. Having surgical therapy or undergoing orthodontic treatment. Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis. Pregnant and lactation females. Smoking ˃ 10 cigarettes/day. Patients with poor oral hygiene. Any known allergies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hyaluronic acid<br>Application of crosslinked HA gel in pockets after subgingival debridement immediately and one week after. | Drug: Hyaluronic acid<br>* anti-inflammatory, anti-edematous, osseoinductive.<br>* Other names: Gingigel /Germany;|
| Active Comparator: scaling and root planing<br>scaling and root planing using ultrasonic scaler and hand instruments. | Drug: Hyaluronic acid<br>* anti-inflammatory, anti-edematous, osseoinductive.<br>* Other names: Gingigel /Germany;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level gain | Clinical attachment gain by using UNC15 Periodontal probe/ numerical data | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pocket depth reduction | Pocket depth reduction by using UNC15 Periodontal probe/ numerical data | 3 moths | 
| Bleeding on probing | Bleeding on probing by using UNC15 Periodontal probe/ binary data | 3 months | 
| Gingival Recession | Gingival Recession by using UNC15 Periodontal probe/ numerical data | 3 months | 
| Radiographic Evaluation | by using periapical radiograph with standardized acrylic stent | 3 months |