The Impact of Obesity on Nonsurgical Periodontal Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Federal University of Rio Grande do Sul.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Georgia Regents University
Information provided by:
Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01405365
First received: August 23, 2010
Last updated: July 28, 2011
Last verified: August 2010
  Purpose

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).


Condition Intervention
Periodontitis
Periodontal Diseases
Obesity
Drug: Metronidazole
Drug: Placebo
Procedure: Scaling and root planning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Impact of Obesity on Nonsurgical Periodontal Treatment of Destructive Periodontal Diseases

Resource links provided by NLM:


Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Probing depth [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.


Secondary Outcome Measures:
  • Attachment level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Defined as the distance from the CEJ to the bottom of the pocket/sulcus.


Estimated Enrollment: 96
Study Start Date: August 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metronidazole Drug: Metronidazole
Metronidazole 400mg TID for 10 days
Other Name: Flagyl
Procedure: Scaling and root planning
Scaling and root planning performed with curettes and ultrasonic scalers under local anesthesia
Other Name: Nonsurgical periodontal therapy
Placebo Comparator: Placebo Drug: Placebo
Placebo pill TID for 10 days
Other Names:
  • Inactive Substance
  • Inactive Drug
Procedure: Scaling and root planning
Scaling and root planning performed with curettes and ultrasonic scalers under local anesthesia
Other Name: Nonsurgical periodontal therapy

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
  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405365

Contacts
Contact: Eduardo J Gaio, DDS 55 51 9252 4577 dudagaio@hotmail.com
Contact: Juliano Cavagni, DDS 55 54 8111 9440 jcavagni@hotmail.com

Locations
Brazil
Universidade Federal do Rio Grande do Sul Recruiting
Porto Alegre, RS, Brazil, 90035-003
Contact: Eduardo J Gaio, DDS    55 51 9252 4577      
Contact: Juliano Cavagni, DDS    55 54 8111 9440    jcavagni@hotmail.com   
Principal Investigator: Cassiano K Rosing, DDS, PhD         
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Georgia Regents 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
  More Information

No publications provided

Responsible Party: Cassiano K. Rosing, Faculdade de Odontologia, Universidade Federal do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01405365     History of Changes
Other Study ID Numbers: CNPq-402335/2008-2
Study First Received: August 23, 2010
Last Updated: July 28, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio Grande do Sul:
Periodontitis
Periodontal diseases
Obesity
Metronidazole
Prognosis
Probing depth
Periodontal attachment loss

Additional relevant MeSH terms:
Periodontal Diseases
Obesity
Periodontitis
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014