Treatment of Periodontitis in Obese Individuals

Periodontitis Clinical Trial

— CLIMBEO  

Official title:

Clinical, Microbial and Biochemistry Evaluation of Obese Individuals Submitted to One-stage Full-mouth Disinfection. A Clinical Control Parallel Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103204
• Other study ID #: UTaubate
• Status: Completed
• Phase: Phase 4
• Start date: January 21, 2017
• Est. completion date: December 28, 2017

Study information

• Verified date: July 2019
• Source: University of Taubate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 28, 2017
• Est. primary completion date: July 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Moderate to advanced generalized chronic periodontitis

• Body mass index: > 18.5 kg/m2

• Minimum of 12 natural teeth

• Smokers, non-smokers or former-smokers

Exclusion Criteria:

• Systemic diseases (diabetes, renal diseases, rheumatic diseases, osteoporosis and cardiovascular diseases)

• Pregnant and lactating women

• HIV/ AIDS

• periodontal treatment in the last year (before baseline appointment)

• Medication: Immunosuppressive drugs, antibiotics in the past three months (before baseline appointment) )

• orthodontic appliance

Related Conditions & MeSH terms

• Obese
• Obesity, Morbid
• Periodontitis

Intervention

Combination Product:
• One-stage full-mouth disinfection with chlorhexidine
Mechanical procedures, composed of full-mouth dental scaling and root planning and dental prophylaxis, will be completed within 24 hours (2 appointments in 2 consecutive mornings or afternoons). Chlorhexidine will be used as the antimicrobial agent in different concentrations (0.2%, 1% and 2%) and vehicles (solution, gel). Oral hygiene instructions will be given for all participants.

Locations

Country	Name	City	State
Brazil	University of Taubate	Taubate	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Taubate

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Systemic effects	Glycemic blood levels.	Changes in in glycemic levels from baseline to 6 months.
Other	Systemic effects	Blood levels of high density lipoprotein-cholesterol, low density lipoprotein -cholesterol, very low density lipoprotein - fractions levels parameters.	Changes in blood levels of high density lipoprotein-cholesterol, low density lipoprotein -cholesterol and very low density lipoprotein - fractions from baseline to 6 months.
Other	Systemic effects	Blood counts of white cells, red cells and platelets.	Changes in blood counts of white cells, red cells and platelets from baseline to 6 months.
Primary	Periodontal clinical efficacy	Improvements in periodontal pocket depth (mm) overtime and comparisons among groups at 6 months after treatment	Changes in periodontal pocket depth measurements from baseline to 6 months
Primary	Periodontal clinical efficacy	Improvements in clinical attachment level (mm) overtime and comparisons among groups at 6 months after treatment	Changes in clinical attachment measurements from baseline to 6 months
Secondary	Antimicrobial efficacy	Reductions in total bacterial levels and levels of target bacterial species overtime and comparisons among groups at 6 months after treatment	Changes in total bacterial levels from baseline to 6 months
Secondary	Antimicrobial efficacy	Reductions in Treponema denticola, Porphyromonas gingivalis, Tannerella forsythia, Aggregatibacter actinomycetemcomitans levels overtime and comparisons among groups at 6 months after treatment	Changes in bacterial levels from baseline to 6 months
Secondary	Oral safety and tolerability	Maintenance of salivary nitrite levels overtime and comparisons among groups at 6 months after treatment	Changes in salivary nitrite levels from baseline to 6 months
Secondary	Impact on quality of life	Improvements in Oral health and quality of life - United Kingdom questionnaire scores overtime and comparisons among groups at 6 months after treatment	Changes in scores (Likert scale ranging from 16 to 80 points) of Oral health and quality of life - United Kingdom questionnaire from baseline to 6 months
Secondary	Impact on quality of life	Improvements in Oral impacts on daily performance questionnaire scores overtime and comparisons among groups at 6 months after treatment	Changes in scores (Likert scale ranging from 0 to 56 points) of Oral impacts on daily performance questionnaire from baseline to 6 months