The Impact of Obesity on Nonsurgical Periodontal Therapy

July 28, 2011 updated by: Federal University of Rio Grande do Sul

The Impact of Obesity on Nonsurgical Periodontal Treatment of Destructive Periodontal Diseases

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  1. scaling and root planing + placebo
  2. scaling and root planing + metronidazole

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-003
        • Recruiting
        • Universidade Federal do Rio Grande do Sul
        • Contact:
        • Contact:
          • Eduardo J Gaio, DDS
          • Phone Number: 55 51 9252 4577
        • Principal Investigator:
          • Cassiano K Rosing, DDS, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Procedure: Scaling and root planning
Scaling and root planning performed with curettes and ultrasonic scalers under local anesthesia
Other Names:
  • Nonsurgical periodontal therapy
Drug: Placebo
Placebo pill TID for 10 days
Other Names:
  • Inactive Drug
  • Inactive Substance
Experimental: Metronidazole
Drug: Metronidazole
Metronidazole 400mg TID for 10 days
Other Names:
  • Flagyl
Procedure: Scaling and root planning
Scaling and root planning performed with curettes and ultrasonic scalers under local anesthesia
Other Names:
  • Nonsurgical periodontal therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Collaborators

Augusta University

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 23, 2010

First Submitted That Met QC Criteria

July 28, 2011

First Posted (Estimate)

July 29, 2011

Study Record Updates

Last Update Posted (Estimate)

July 29, 2011

Last Update Submitted That Met QC Criteria

July 28, 2011

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNPq-402335/2008-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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