The Impact of Obesity on Nonsurgical Periodontal Therapy

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01405365
• Other study ID #: CNPq-402335/2008-2
• 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

Related Conditions & MeSH terms

• Gingival Diseases
• Obesity
• Periodontal Diseases
• Periodontitis

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