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

NCT ID: NCT03923829

Last Updated: 2019-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-30

Study Completion Date

2020-08-30

Brief Summary

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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

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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

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessor and statistician will be blinded to the intervention

Study Groups

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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

Group Type EXPERIMENTAL

Zinc Sulfate

Intervention Type DRUG

systemic administration of Zinc sulfate with scaling and root planing

scaling and root planing

scaling and root planing

Group Type ACTIVE_COMPARATOR

scaling and root planing

Intervention Type PROCEDURE

scaling and root planing

Interventions

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Zinc Sulfate

systemic administration of Zinc sulfate with scaling and root planing

Intervention Type DRUG

scaling and root planing

scaling and root planing

Intervention Type PROCEDURE

Other Intervention Names

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Zinc Sulfate with scaling and root planing

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Abdulrahman Abdulqawi Awadh Abdulrab

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Enji Ahmed, professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Dr. weam elbattawy, Lecturer

Role: STUDY_DIRECTOR

Cairo University

Dr. Ollfat Shaker, professor

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

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abdulrahman A Abdulrab

Role: CONTACT

+201014624724

Dr. Enji Ahmed, professor

Role: CONTACT

+201018941119

References

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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.

Reference Type RESULT
PMID: 24082728 (View on PubMed)

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.

Reference Type RESULT
PMID: 28566858 (View on PubMed)

Other Identifiers

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6653486

Identifier Type: -

Identifier Source: org_study_id

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