NCT03783845

Brief Summary

Is the non-surgical periodontal therapy can improve glycemic control in type 2 diabetic patients with chronic periodontitis?

Trial Health

100
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_4

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

9 months

First QC Date

December 19, 2018

Last Update Submit

October 17, 2019

Conditions

Chronic Periodontitis, Generalized

Outcome Measures

Primary Outcomes (1)

  • glycosylated haemoglobin (HbA1c)

    Blood was taken from a peripheral vein to monitor HbA1c using high-performance liquid chromatography

    3 months

Study Arms (2)

test group

EXPERIMENTAL

Metronidazole 400mg,three times daily for two weeks Amoxicillin 500mg,three times daily for two weeks.

Combination Product: amoxicillin 500mg and metronidazole 400mg

control group

NO INTERVENTION

no intervention during study period

Interventions

amoxicillin 500mg and metronidazole 400mgCOMBINATION_PRODUCT

metronidazole 400mg and amoxicillin 500mg three times daily for two weeks

Also known as: Amoxil and Flagyl
test group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of diabetes type 2 for more than five years Type 2 diabetes with HbA1c level from 7% to 9% at the last medical evaluation Diagnosis with chronic periodontitis

You may not qualify if:

  • Pregnancy
  • Alcoholism and smoking
  • Presence of any systemic disorders other than hypertension and diabetes
  • Diabetic major complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

AmoxicillinMetronidazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

December 19, 2018

First Posted

December 21, 2018

Study Start

June 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 30, 2016

Last Updated

October 21, 2019

Record last verified: 2019-10