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

Not Applicable

• Conditions: Chronic Periodontitis
• Interventions: Procedure: scaling and root planing; Drug: Zinc Sulfate

• Registration Number: NCT03923829
• Lead Sponsor: Cairo University

Brief Summary

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

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

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-22
• Last Update Submitted: 2019-04-22
• Study First Posted: 2019-04-23
• Last Update Posted: 2019-04-23
• Study Start: 2019-04-30
• Primary Completion: 2020-08-30
• Study Completion: 2020-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
scaling and root planing	scaling and root planing	scaling and root planing
Zinc administration with scaling and root planing	Zinc Sulfate	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

Primary Outcome Measures

Name	Time	Method
change from baseline Hb-A1c	change from baseline Hb-A1c at 3 monthes

Secondary Outcome Measures

Name	Time	Method
Clinical attachment level	at the baseline and after 3 months	It will be measured from the cemento-enamel junction till the apical part of the pocket.
Probing pocket depth	at the baseline and after 3 months	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.
Hb-A1c	at the baseline and after 3 months	Hb-A1c
Gingival index	at the baseline and after 3 months	Gingival Index for a specific tooth == Average (points for the 4 surfaces)