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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Procedure: scaling and root planing; Drug: Zinc Sulfate

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 Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: abdulrahman A Abdulrab; Phone Number: +201014624724; Email: abdulrahman.awadh@dentistry.cu.edu.eg
• Study Contact Backup: Name: Dr. Enji Ahmed, professor; Phone Number: +201018941119; Email: enji.ahmed@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zinc administration with scaling and root planing; 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; systemic administration of Zinc sulfate with scaling and root planing; Other Names: Zinc Sulfate with scaling and root planing
Active Comparator: scaling and root planing	Procedure: scaling and root planing; scaling and root planing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Dr. Enji Ahmed, professor, Cairo University; Study Director: Dr. weam elbattawy, Lecturer, Cairo University; Study Director: Dr. Ollfat Shaker, professor, Cairo University

Publications and helpful links

General Publications

• Khan MI, Siddique KU, Ashfaq F, Ali W, Reddy HD, Mishra A. Effect of high-dose zinc supplementation with oral hypoglycemic agents on glycemic control and inflammation in type-2 diabetic nephropathy patients. J Nat Sci Biol Med. 2013 Jul;4(2):336-40. doi: 10.4103/0976-9668.117002.
• Thomas B, Prasad RB, Shetty S, Vishakh R. Comparative Evaluation of the Lipid Profile in the Serum of Patients with Type II Diabetes Mellitus and Healthy Individuals with Periodontitis. Contemp Clin Dent. 2017 Jan-Mar;8(1):96-101. doi: 10.4103/ccd.ccd_1160_16.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2019
• Primary Completion (Anticipated): August 30, 2020
• Study Completion (Anticipated): August 30, 2020

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (Actual): April 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: zinc; Type 2 diabetic patients; gingival crevicular fluid; Non-surgical Periodontal Therapy; stage II periodontitis; stage III periodontitis; total oxidant capacity
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Physiological Effects of Drugs; Dermatologic Agents; Trace Elements; Micronutrients; Astringents; Zinc; Zinc Sulfate
• Other Study ID Numbers: 6653486

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No