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Status unknownNCT03923829Updated Apr 23, 2019

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

An interventional study of Zinc Sulfate and scaling and root planing in Chronic Periodontitis, sponsored by Cairo University. Status unknown. Per ClinicalTrials.gov, last updated 2019-04-23.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Sex
All
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Study 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.

Read the 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

02

Conditions studied

  • Chronic Periodontitis

Keywords

  • zinc
  • Non-surgical Periodontal Therapy
  • stage II periodontitis
  • stage III periodontitis
  • gingival crevicular fluid
  • total oxidant capacity
  • Type 2 diabetic patients
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In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's planned enrollment of 34 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (estimated)

Study arms

  • 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

  • Active comparator
    scaling and root planing

    scaling and root planing

    Procedure: scaling and root planing

Interventions

  • DrugZinc Sulfate

    systemic administration of Zinc sulfate with scaling and root planing

    Also known as: Zinc Sulfate with scaling and root planing

  • Procedurescaling and root planing

    scaling and root planing

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What researchers measure

Primary outcomes

  1. change from baseline Hb-A1c

    Time frame: change from baseline Hb-A1c at 3 monthes

Secondary outcomes

  1. Hb-A1c

    Hb-A1c

    Time frame: at the baseline and after 3 months

  2. 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.

    Time frame: at the baseline and after 3 months

  3. Clinical attachment level

    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

  4. Gingival index

    Gingival Index for a specific tooth == Average (points for the 4 surfaces)

    Time frame: at the baseline and after 3 months

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 24082728 ↗
  • 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. PubMed 28566858 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03923829
Lead sponsor
Cairo University
Responsible party
Abdulrahman Abdulqawi Awadh Abdulrab (Principal Investigator, Cairo University) — Principal investigator
First posted
Apr 23, 2019
Start date
Apr 30, 2019 (estimated)
Primary completion
Aug 30, 2020 (estimated)
Completion
Aug 30, 2020 (estimated)
Last update
Apr 23, 2019

Study contacts

abdulrahman A Abdulrab
Contact
abdulrahman.awadh@dentistry.cu.edu.eg
+201014624724
Dr. Enji Ahmed, professor
Contact
enji.ahmed@dentistry.cu.edu.eg
+201018941119
Dr. Enji Ahmed, professor
principal investigator · Cairo University
Dr. weam elbattawy, Lecturer
study director · Cairo University
Dr. Ollfat Shaker, professor
study director · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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