NCT03923829

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

April 17, 2019

Last Update Submit

April 22, 2019

Conditions

Chronic Periodontitis

Keywords

zincNon-surgical Periodontal Therapystage II periodontitisstage III periodontitisgingival crevicular fluidtotal oxidant capacityType 2 diabetic patients

Outcome Measures

Primary Outcomes (1)

  • change from baseline Hb-A1c

    change from baseline Hb-A1c at 3 monthes

Secondary Outcomes (4)

  • Hb-A1c

    at the baseline and after 3 months

  • Probing pocket depth

    at the baseline and after 3 months

  • Clinical attachment level

    at the baseline and after 3 months

  • Gingival index

    at the baseline and after 3 months

Study Arms (2)

Zinc administration with scaling and root planing

EXPERIMENTAL

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

scaling and root planing

ACTIVE COMPARATOR

scaling and root planing

Procedure: scaling and root planing

Interventions

Zinc SulfateDRUG

systemic administration of Zinc sulfate with scaling and root planing

Also known as: Zinc Sulfate with scaling and root planing
Zinc administration with scaling and root planing
scaling and root planingPROCEDURE

scaling and root planing

scaling and root planing

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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: 10.4103/0976-9668.117002.

    PMID: 24082728RESULT

  • 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.

    PMID: 28566858RESULT

MeSH Terms

Conditions

Chronic PeriodontitisPeriodontitis

Interventions

Zinc SulfateTooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc CompoundsDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Dr. Enji Ahmed, professor

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Dr. weam elbattawy, Lecturer

    Cairo University

    STUDY DIRECTOR

  • Dr. Ollfat Shaker, professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

abdulrahman A Abdulrab

CONTACT

+201014624724abdulrahman.awadh@dentistry.cu.edu.eg

Dr. Enji Ahmed, professor

CONTACT

+201018941119enji.ahmed@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor and statistician will be blinded to the intervention
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 23, 2019

Study Start

April 30, 2019

Primary Completion

August 30, 2020

Study Completion

August 30, 2020

Last Updated

April 23, 2019

Record last verified: 2019-04