Azithromycin Versus Doxycycline on Restistin Level in Per... | NCT06199440

Studies
Azithromycin Versus Doxycycline on Restistin Level in Periodontitis Patients With Type 2 Diabetes

NCT06199440

Sponsor

King Abdulaziz University

Status

Completed

Last Update Posted

Jan 10, 2024Actual

Enrollment

15Actual

Phase

Phase 1Phase 2

Conditions

Periodontal Diseases
Type 2 Diabetes

Interventions

Group I
Group II
Group III

Countries

Saudi Arabia

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

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, 2022Actual

Primary Completion Date

Mar 30, 2023Actual

Completion Date

Mar 30, 2023Actual

First Submitted Date

Dec 29, 2023

First Submission Date that Met QC Criteria

Dec 29, 2023

First Posted Date

Jan 10, 2024Actual

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

Dec 29, 2023

Last Update Posted Date

Jan 10, 2024Actual

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

The aim of this study is to evaluate the adjunctive effects of systemic antibiotics used in nonsurgical periodontal treatment (NSPT), compared with NSPT alone, on the periodontal clinical parameters and resistin level in diabetic patients with periodontitis, in order to identify which, one provides an additional effect to non-surgical periodontal therapy

Detailed Description

Not provided

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I	Active Comparator	Chronic periodontitis patients with diabetes mellitus type II who received scaling and root planning.	Drug: Group I
Group II	Experimental	Received azithromycin dosage is 250 mg/day for 5 days, after an initial dose of 500 mg one hour before NSPT	Drug: Group II
Group III	Experimental	Consisted of 5 type 2 Diabetes Mellitus patients with periodontitis who were received doxycycline 20mg twice/day.	Drug: Group III

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Group I	Drug	First group are chronic periodontitis patients with diabetes mellitus type II who received scaling and root planning.	Group I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Outcome	Improvements in clinical parameters of periodontitis including Gingival Index, Probing Depth and Clinical Attachment Level	3 months

Secondary Outcomes

Measure	Description	Time Frame
Secondary Outcome	Improved resistin level	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients were clinically diagnosed as having at least three site with CAL ≥ 5mm; moderate to advanced chronic periodontitis according to the criteria of American Academy of Periodontology.

Free from any other systemic conditions that affect the periodontium except for Diabetes mellitus type II.
No periodontal therapy, systemic antibiotics or non-steroidal anti-inflammatory agents during the preceding 6 months.
Non-smokers.
Non-pregnant.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Abdulaziz University		Jeddah			Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010510	Periodontal Diseases
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided