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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01405365
Other study ID # CNPq-402335/2008-2
Secondary ID
Status Recruiting
Phase N/A
First received August 23, 2010
Last updated July 28, 2011
Start date August 2009
Est. completion date December 2012

Study information

Verified date August 2010
Source Federal University of Rio Grande do Sul
Contact Eduardo J Gaio, DDS
Phone 55 51 9252 4577
Email dudagaio@hotmail.com
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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).


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


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date December 2012
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years to 55 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Intervention

Drug:
Metronidazole
Metronidazole 400mg TID for 10 days
Placebo
Placebo pill TID for 10 days
Procedure:
Scaling and root planning
Scaling and root planning performed with curettes and ultrasonic scalers under local anesthesia

Locations

Country Name City State
Brazil Universidade Federal do Rio Grande do Sul Porto Alegre RS

Sponsors (2)

Lead Sponsor Collaborator
Federal University of Rio Grande do Sul Georgia Regents University

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Probing depth Defined as the distance from the free gingival margin to the bottom of the pocket/sulcus. 12 months No
Secondary Attachment level Defined as the distance from the CEJ to the bottom of the pocket/sulcus. 12 months No
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