The Impact of Obesity on Nonsurgical Periodontal Therapy | NCT01405365

Studies
The Impact of Obesity on Nonsurgical Periodontal Therapy

NCT01405365

Sponsor

Federal University of Rio Grande do Sul

Status

Unknown status

Last Update Posted

Jul 29, 2011Estimated

Enrollment

96Estimated

Phase

Not Applicable

Conditions

Periodontitis
Periodontal Diseases
Obesity

Interventions

Metronidazole
Placebo
Scaling and root planning

Countries

Brazil

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

Aug 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Aug 23, 2010

First Submission Date that Met QC Criteria

Jul 28, 2011

First Posted Date

Jul 29, 2011Estimated

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

Jul 28, 2011

Last Update Posted Date

Jul 29, 2011Estimated

Name	Class
Augusta University	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 purpose of this study is to investigate the effect that obesity may have on the nonsurgical treatment (with and without the adjunct use of metronidazole) of destructive periodontal diseases (chronic periodontitis).

Detailed Description

Normal weight (BMI 18.5-24.9 kg/m2) and obese (BMI >30 kg/m2) women will be randomly assigned to two nonsurgical periodontal treatments:

scaling and root planing + placebo
scaling and root planing + metronidazole

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metronidazole	Experimental		Drug: Metronidazole Procedure: Scaling and root planning
Placebo	Placebo Comparator		Drug: Placebo Procedure: Scaling and root planning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metronidazole	Drug	Metronidazole 400mg TID for 10 days	Metronidazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Probing depth	Defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Attachment level	Defined as the distance from the CEJ to the bottom of the pocket/sulcus.	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal weight or obese (according to BMI)
nonsmokers or former smokers (3 or more years)
no systemic diseases that may affect periodontal treatment (diabetes, osteoporosis, steroid use)
have 10 teeth present
have at least 2 teeth with probing depth 6+mm and attachment loss 4+mm

Exclusion Criteria:

Pregnancy
Development of diabetes or other conditions that may impair periodontal healing

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eduardo J Gaio, DDS	Contact	55 51 9252 4577		dudagaio@hotmail.com
Juliano Cavagni, DDS	Contact	55 54 8111 9440		jcavagni@hotmail.com

Overall Officials

Name	Affiliation	Role
Cassiano K Rosing, DDS, PhD	Federal University of Rio Grande do Sul	Principal Investigator
Cristiano Susin, DDS, PhD	Medical College of Georgia School of Dentistry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidade Federal do Rio Grande do Sul	Recruiting	Porto Alegre	Rio Grande do Sul	90035-003	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D010518	Periodontitis
D010510	Periodontal Diseases
D009765	Obesity
D017622	Periodontal Attachment Loss

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D050177	Overweight
D044343	Overnutrition

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008795	Metronidazole
D014080	Tooth Exfoliation

Ancestor Terms

ID	Term
D009593	Nitroimidazoles
D009574	Nitro Compounds
D009930	Organic Chemicals
D007093	Imidazoles

Browse Leaves

Not provided

Browse Branches

Not provided