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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
History of Changes

August 23, 2010
July 28, 2011
August 2009
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01405365 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
The Impact of Obesity on Nonsurgical Periodontal Therapy
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).

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Periodontitis
  • Periodontal Diseases
  • Obesity
  • Drug: Metronidazole
    Metronidazole 400mg TID for 10 days
    Other Name: Flagyl
  • 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
  • Experimental: Metronidazole
    Interventions:
    • Drug: Metronidazole
    • Procedure: Scaling and root planning
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Procedure: Scaling and root planning
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
96
December 2012
December 2011   (final data collection date for primary outcome measure)

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
Female
35 Years to 55 Years
Yes
Contact: Eduardo J Gaio, DDS 55 51 9252 4577 dudagaio@hotmail.com
Contact: Juliano Cavagni, DDS 55 54 8111 9440 jcavagni@hotmail.com
Brazil
 
NCT01405365
CNPq-402335/2008-2
No
Cassiano K. Rosing, Faculdade de Odontologia, Universidade Federal do Rio Grande do Sul
Federal University of Rio Grande do Sul
Georgia Regents University
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
Federal University of Rio Grande do Sul
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP