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The Impact of Obesity on Nonsurgical Periodontal Therapy

Primary Purpose

Periodontitis, Periodontal Diseases, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Metronidazole
Placebo
Scaling and root planning
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Periodontitis, Periodontal diseases, Obesity, Metronidazole, Prognosis, Probing depth, Periodontal attachment loss

Eligibility Criteria

35 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universidade Federal do Rio Grande do SulRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metronidazole

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Probing depth
Defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.

Secondary Outcome Measures

Attachment level
Defined as the distance from the CEJ to the bottom of the pocket/sulcus.

Full Information

First Posted
August 23, 2010
Last Updated
July 28, 2011
Sponsor
Federal University of Rio Grande do Sul
Collaborators
Augusta University
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1. Study Identification

Unique Protocol Identification Number
NCT01405365
Brief Title
The Impact of Obesity on Nonsurgical Periodontal Therapy
Official Title
The Impact of Obesity on Nonsurgical Periodontal Treatment of Destructive Periodontal Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of Rio Grande do Sul
Collaborators
Augusta University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Periodontal Diseases, Obesity
Keywords
Periodontitis, Periodontal diseases, Obesity, Metronidazole, Prognosis, Probing depth, Periodontal attachment loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metronidazole
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Other Intervention Name(s)
Flagyl
Intervention Description
Metronidazole 400mg TID for 10 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Inactive Substance, Inactive Drug
Intervention Description
Placebo pill TID for 10 days
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planning
Other Intervention Name(s)
Nonsurgical periodontal therapy
Intervention Description
Scaling and root planning performed with curettes and ultrasonic scalers under local anesthesia
Primary Outcome Measure Information:
Title
Probing depth
Description
Defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Attachment level
Description
Defined as the distance from the CEJ to the bottom of the pocket/sulcus.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo J Gaio, DDS
Phone
55 51 9252 4577
Email
dudagaio@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Juliano Cavagni, DDS
Phone
55 54 8111 9440
Email
jcavagni@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassiano K Rosing, DDS, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cristiano Susin, DDS, PhD
Organizational Affiliation
Medical College of Georgia School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Sul
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo J Gaio, DDS
Phone
55 51 9252 4577
First Name & Middle Initial & Last Name & Degree
Juliano Cavagni, DDS
Phone
55 54 8111 9440
Email
jcavagni@hotmail.com
First Name & Middle Initial & Last Name & Degree
Cassiano K Rosing, DDS, PhD

12. IPD Sharing Statement

Learn more about this trial

The Impact of Obesity on Nonsurgical Periodontal Therapy

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