Adjunctive Systemic Administration of Moxifloxacin in the... | NCT02125812

Studies
Adjunctive Systemic Administration of Moxifloxacin in the Treatment of Aggressive Periodontitis

NCT02125812

Sponsor

Facultad Nacional de Salud Publica

Status

Completed

Last Update Posted

Jun 2, 2014Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Aggressive Periodontitis

Interventions

scaling and systemic moxifloxacin
scaling and root planing

Countries

Colombia

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

May 2014

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

Aug 2011

Primary Completion Date

Mar 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Apr 25, 2014

First Submission Date that Met QC Criteria

Apr 28, 2014

First Posted Date

Apr 29, 2014Estimated

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

May 29, 2014

Last Update Posted Date

Jun 2, 2014Estimated

Name	Class
Universidad de Antioquia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 adjunctive use of systemically administered antibiotics has been shown to provide a better clinical outcome, particularly in terms of probing depth (PD) reduction and attachment-level gain than SRP in subjects with Aggressive Periodontitis.

The overall objective of this study is to evaluate the clinical and microbiological efficacy of moxifloxacin as an adjunct to scaling and root planing versus scaling and root planing over placebo in the treatment of aggressive periodontitis.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
scaling and root planing	Placebo Comparator	scaling and root planing	Other: scaling and root planing
scaling and systemic moxifloxacin	Experimental	scaling and root planing combined with systemic moxifloxacin	Other: scaling and systemic moxifloxacin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
scaling and systemic moxifloxacin	Other	scaling and root planing (SRP) combined with systemic moxifloxacin	scaling and systemic moxifloxacin

Measure	Description	Time Frame
probing depth		six months

Measure	Description	Time Frame
clinical attachment level and probing depth		6 moths

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

under 30 years old and systemically healthy, with at least 20 teeth present. Be willing to participate in the study which is corroborated by signing the informed consent form.

Commit to attend post-therapeutic controls and stop drinking alcohol during the time of ingestion of antibiotics.

Exclusion Criteria:

Subjects in whom are contraindicated or with hypersensitivity to quinolones - Subjects who have undergone periodontal, surgical or mechanical antibiotic therapy six months before the start of the study according to interrogation.

Women in pregnancy or lactation, corroborated with previous medical history and medical consultation.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carlos M Ardila, Ph.D	Universidad de Antioquia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry		Departamento de Antioquia	Medellin		Colombia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33197289	Derived	Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.

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

ID	Term
D014080	Tooth Exfoliation
D016745	Root Planing

ID	Term
D009063	Dental Physiological Phenomena
D055688	Digestive System and Oral Physiological Phenomena
D012534	Dental Scaling
D003777	Dental Prophylaxis