The Effect of Zinc on the Gingival Crevicular Fluid Level of Total Oxidant Capacity in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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To evaluate the effect of systemic administration of zinc on the gingival crevicular fluid level of total oxidant capacity in controlled Type-2 diabetic patients with stage-II and III periodontitis after non-surgical periodontal therapy.

Detailed Description
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Hypozincaemia and hyperzincuria is known to be present in patients with type-2 diabetes, and Zinc supplementation is known to be helpful in restoring plasma Zinc levels to normal,Zinc's deficiency can lead to an increase in circulating glucose due to beta cells malfunctioning and resistance to insulin, which makes it easier for type 2 diabetes mellitus (DM2) to happen ,Zinc was found to be a structural part of key anti-oxidant enzymes such as superoxide dismutase (SOD), and Zinc deficiency impaired their synthesis, leading to increased oxidative stress

Official Title
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The Effect of Systemic Administration of Zinc on the Gingival Crevicular Fluid Level of Total Oxidant Capacity in Type 2 Diabetic Patients With Stage II and III Periodontitis After Non-surgical Periodontal Therapy

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: Zinc Sulfate
* Procedure: scaling and root planing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Controlled Type-2 diabetes mellitus Stage-II &III periodontitis At least 2 sites with clinical attachment loss 3 or 4 mm to ≥5 mm and radiographic bone loss 15% Extending to mid-third of root and beyond. Probing depth from ≤5 mm to ≥6 mm Exclusion Criteria: Any periodontal or Antibiotic treatment during the last six months. Receiving trace element supplements in the previous three months Pregnant or lactating females Gastric or diuretic treatment Acute renal failure smoking
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc administration with scaling and root planing<br>systemic administration of Zinc cap of 50 mg elemental zinc as zinc sulphate, once a day for 12 weeks in addition to scaling and root planing | Drug: Zinc Sulfate<br>* systemic administration of Zinc sulfate with scaling and root planing<br>* Other names: Zinc Sulfate with scaling and root planing;|
| Active Comparator: scaling and root planing<br>scaling and root planing | Procedure: scaling and root planing<br>* scaling and root planing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline Hb-A1c |  | change from baseline Hb-A1c at 3 monthes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb-A1c | Hb-A1c | at the baseline and after 3 months | 
| Probing pocket depth | Probing pocket depth Measured as the distance between the gingival margin and the apical part of the pocket will be measured using William's graduated periodontal probe. | at the baseline and after 3 months | 
| Clinical attachment level | It will be measured from the cemento-enamel junction till the apical part of the pocket. | at the baseline and after 3 months | 
| Gingival index | Gingival Index for a specific tooth == Average (points for the 4 surfaces) | at the baseline and after 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zinc, Non-surgical Periodontal Therapy, stage II periodontitis, stage III periodontitis, gingival crevicular fluid, total oxidant capacity, Type 2 diabetic patients