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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03923829
• Other study ID #: 6653486
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: April 2019
• Source: Cairo University
• Contact: abdulrahman A Abdulrab
• Phone: +201014624724
• Email: abdulrahman.awadh[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Zinc Sulfate
systemic administration of Zinc sulfate with scaling and root planing

Procedure:
• scaling and root planing
scaling and root planing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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: — View Citation

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_116 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline Hb-A1c		change from baseline Hb-A1c at 3 monthes
Secondary	Hb-A1c	Hb-A1c	at the baseline and after 3 months
Secondary	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
Secondary	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
Secondary	Gingival index	Gingival Index for a specific tooth == Average (points for the 4 surfaces)	at the baseline and after 3 months