The Effects of Periodontal Therapy on Glycemic Control in... | NCT03783845

Studies
The Effects of Periodontal Therapy on Glycemic Control in Diabetic Patients

NCT03783845

Sponsor

Taibah University

Status

Completed

Last Update Posted

Oct 21, 2019Actual

Enrollment

44Actual

Phase

Phase 4

Conditions

Chronic Periodontitis, Generalized

Interventions

amoxicillin 500mg and metronidazole 400mg

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2015Actual

Primary Completion Date

Mar 1, 2016Actual

Completion Date

Mar 30, 2016Actual

First Submitted Date

Dec 19, 2018

First Submission Date that Met QC Criteria

Dec 19, 2018

First Posted Date

Dec 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2019

Last Update Posted Date

Oct 21, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

The aim of the present study was to monitor the clinical outcomes and the metabolic response of non-surgical periodontal therapy in patients with chronic periodontitis and uncontrolled type 2 diabetes.

Regarding clinical and metabolic parameters at baseline, no differences were displayed between two groups. However, at 3-months follow-up period the patients within a test group were demonstrated better clinical outcomes than patients in a control group

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
amoxicillin 500mg and metronidazole 400mg	Combination Product	metronidazole 400mg and amoxicillin 500mg three times daily for two weeks	test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
glycosylated haemoglobin (HbA1c)	Blood was taken from a peripheral vein to monitor HbA1c using high-performance liquid chromatography	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 11, 2018	Dec 23, 2018	Prot_SAP_001.pdf

Condition Browse Module

MeSH Terms

ID	Term
D055113	Chronic Periodontitis

Ancestor Terms

ID	Term
D010518	Periodontitis
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000658	Amoxicillin
D008795	Metronidazole

Ancestor Terms

ID	Term
D000667	Ampicillin
D010400	Penicillin G
D010406	Penicillins
D047090	beta-Lactams
D007769

Browse Leaves

Not provided

Browse Branches

Not provided