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

Primary Purpose

Chronic Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Zinc Sulfate
scaling and root planing
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring zinc, Non-surgical Periodontal Therapy, stage II periodontitis, stage III periodontitis, gingival crevicular fluid, total oxidant capacity, Type 2 diabetic patients

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Zinc administration with scaling and root planing

    scaling and root planing

    Arm Description

    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

    scaling and root planing

    Outcomes

    Primary Outcome Measures

    change from baseline Hb-A1c

    Secondary Outcome Measures

    Hb-A1c
    Hb-A1c
    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.
    Clinical attachment level
    It will be measured from the cemento-enamel junction till the apical part of the pocket.
    Gingival index
    Gingival Index for a specific tooth == Average (points for the 4 surfaces)

    Full Information

    First Posted
    April 17, 2019
    Last Updated
    April 22, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03923829
    Brief Title
    The Effect of Zinc on the Gingival Crevicular Fluid Level of Total Oxidant Capacity in Type 2 Diabetic Patients
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 30, 2019 (Anticipated)
    Primary Completion Date
    August 30, 2020 (Anticipated)
    Study Completion Date
    August 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis
    Keywords
    zinc, Non-surgical Periodontal Therapy, stage II periodontitis, stage III periodontitis, gingival crevicular fluid, total oxidant capacity, Type 2 diabetic patients

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    The outcome assessor and statistician will be blinded to the intervention
    Allocation
    Randomized
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Zinc administration with scaling and root planing
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    scaling and root planing
    Arm Type
    Active Comparator
    Arm Description
    scaling and root planing
    Intervention Type
    Drug
    Intervention Name(s)
    Zinc Sulfate
    Other Intervention Name(s)
    Zinc Sulfate with scaling and root planing
    Intervention Description
    systemic administration of Zinc sulfate with scaling and root planing
    Intervention Type
    Procedure
    Intervention Name(s)
    scaling and root planing
    Intervention Description
    scaling and root planing
    Primary Outcome Measure Information:
    Title
    change from baseline Hb-A1c
    Time Frame
    change from baseline Hb-A1c at 3 monthes
    Secondary Outcome Measure Information:
    Title
    Hb-A1c
    Description
    Hb-A1c
    Time Frame
    at the baseline and after 3 months
    Title
    Probing pocket depth
    Description
    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.
    Time Frame
    at the baseline and after 3 months
    Title
    Clinical attachment level
    Description
    It will be measured from the cemento-enamel junction till the apical part of the pocket.
    Time Frame
    at the baseline and after 3 months
    Title
    Gingival index
    Description
    Gingival Index for a specific tooth == Average (points for the 4 surfaces)
    Time Frame
    at the baseline and after 3 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    abdulrahman A Abdulrab
    Phone
    +201014624724
    Email
    abdulrahman.awadh@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr. Enji Ahmed, professor
    Phone
    +201018941119
    Email
    enji.ahmed@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr. Enji Ahmed, professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Dr. weam elbattawy, Lecturer
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Dr. Ollfat Shaker, professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24082728
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    28566858
    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_1160_16.
    Results Reference
    result

    Learn more about this trial

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

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