NCT03103204: CLIMBEO

Treatment of Periodontitis in Obese Individuals

Completed Phase 4 Last updated 23 July 2019

What this trial tests

Phase 4 trial testing One-stage full-mouth disinfection with chlorhexidine in Obese in 96 participants. Completed in 28 December 2017.

Timeline

21 January 2017

Primary endpoint
28 July 2017

28 December 2017

Quick facts

Lead sponsor	University of Taubate
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	96
Start date	21 January 2017
Primary completion	28 July 2017
Estimated completion	28 December 2017
Sites	1 location across Brazil

Drugs / interventions tested

• One-stage full-mouth disinfection with chlorhexidine

Conditions studied

• Obese — all drugs for Obese →
• Obesity, Morbid — all drugs for Obesity, Morbid →
• Periodontitis — all drugs for Periodontitis →

Sponsor

University of Taubate

Who can join

Adults 18 to 50, any sex, with Obese or Obesity, Morbid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Obesity and gum diseases are highly prevalent in all parts of the world. Obesity can negatively influence severity and progression rates of gum diseases. Presence of fat in the body determines a general systemic state of inflammation. On the other hand, when gum diseases are successfully treated systemic and local inflammation decrease. In addition reductions in glycemic blood levels are also observed after treatment. Periodontitis is one type of gum disease that is associated with bone loss. It could be treated within 24 hours by using a protocol, which combines dental debridement and mouthwash. This treatment protocol, named "one-stage full-mouth disinfection" works well in individuals of normal weight. However, there is no information whether it is effective in obese individuals or not. Also, it should be clarified if obesity influences response to periodontal treatment. This study hypothesized that obesity impair response to periodontal treatment. Therefore, the effects of the protocol "one-stage full-mouth disinfection" will be evaluated in obese individuals and normal weight controls. This evaluation will be based on the monitoring of several clinical, microbiological and biochemical parameters throughout 9 months. Participants will answer validated questionnaires to evaluate if treatment of gum disease would be able to improve individual's quality of life. Study population will be composed of 90 to 100 obese individuals (males or females; \> 18 years of age; smokers or non smokers; \> 12 natural teeth). Participants will be classified into 5 groups according to their body mass index in normal weight (n = 15 to 20); overweight (n = 15 to 20); obesity I (n = 15 to 20); obesity II (n = 15 to 20); obesity III (n = 15 to 20). Examinations will be performed before treatment and also 3, 6 and 9 months after treatment. This study will contribute to the knowledge on how obese individuals respond to this specific treatment protocol. Also, having normal weight individuals as controls the present study will contribute to a better understanding about obesity, in its different severities, influence on periodontal treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical and microbiological evaluation of non-surgical periodontal therapy in obese and non-obese individuals with periodontitis: a 9-month prospective longitudinal study.
   Peralta FDS, Cortelli SC, Rovai ES, Aquino DR, et al · · 2020 · cited 10× · PMID 32428060 · DOI 10.1590/1678-7757-2019-0694