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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03923829

Recruitment Status Not yet recruiting

First Posted April 23, 2019

Last update posted April 23, 2019

Study Description

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.

  • Condition or Disease:Chronic Periodontitis
  • Intervention/Treatment: Drug: Zinc Sulfate
    Procedure: scaling and root planing
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 34 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment
  • 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
  • Estimated Study Start Date: April 2019
  • Estimated Primary Completion Date: August 2020
  • Estimated Study Completion Date: August 2020
Arms and interventions
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
Active Comparator: scaling and root planing
scaling and root planing
Procedure: scaling and root planing
scaling and root planing
Outcome Measures
  • Primary Outcome Measures: 1. change from baseline Hb-A1c [ Time Frame: change from baseline Hb-A1c at 3 monthes ]
  • Secondary Outcome Measures: 1. Hb-A1c [ Time Frame: at the baseline and after 3 months ]
    Hb-A1c
  • 2. Probing pocket depth [ Time Frame: 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.
  • 3. Clinical attachment level [ Time Frame: at the baseline and after 3 months ]
    It will be measured from the cemento-enamel junction till the apical part of the pocket.
  • 4. Gingival index [ Time Frame: at the baseline and after 3 months ]
    Gingival Index for a specific tooth == Average (points for the 4 surfaces)
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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

Contacts and Locations
Contacts

Contact: abdulrahman A Abdulrab +201014624724 abdulrahman.awadh@dentistry.cu.edu.eg

Contact: Dr. Enji Ahmed, professor +201018941119 enji.ahmed@dentistry.cu.edu.eg

Locations
Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Dr. Enji Ahmed, professor faculty of dentistry Cairo university

Study Director: Dr. weam elbattawy, Lecturer faculty of dentistry Cairo university

Study Director: Dr. Ollfat Shaker, professor faculty of dentistry Cairo university

More Information