Treatment of Periodontitis in Obese Individuals (CLIMBEO)

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Obesity, Morbid; Obese
• Intervention / Treatment: Combination product: One-stage full-mouth disinfection with chlorhexidine

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Taubate, Sao Paulo, Brazil, 12020330
      • University of Taubate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal weight full-mouth disinfection; Normal weight (body mass index 18.5 - 24.9 kg/m2) individuals with chronic periodontitis; Full-mouth manual scaling and root planing within 24 hours; tongue cleaning with chlorhexidine gel 1% for 1 minute; tonsils disinfection with chlorhexidine spray 0.2%; rinsing with 15mL of 0.2% chlorhexidine solution for 30 seconds before and after dental scaling; subgingival irrigation of all periodontal pockets with 1% chlorhexidine solution; daily rinsing with 0.2% chlorhexidine solution (15mL/30 seconds/2 times a day	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.
Experimental: Overweight full-mouth disinfection; Overweight (body mass index 25.0 - 29.9 kg/m2) individuals with chronic periodontitis; Full-mouth manual scaling and root planing within 24 hours; tongue cleaning with chlorhexidine gel 1% for 1 minute; tonsils disinfection with chlorhexidine spray 0.2%; rinsing with 15mL of 0.2% chlorhexidine solution for 30 seconds before and after dental scaling; subgingival irrigation of all periodontal pockets with with 1% chlorhexidine solution; daily rinsing with 0.2% chlorhexidine solution (15mL/30 seconds/2 times a day	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.
Experimental: Obesity I full-mouth disinfection; Obesity I (body mass index 30.0 - 34.9 kg/m2) individuals with chronic periodontitis; Full-mouth manual scaling and root planing within 24 hours; tongue cleaning with chlorhexidine gel 1% for 1 minute; tonsils disinfection with chlorhexidine spray 0.2%; rinsing with 15mL of 0.2% chlorhexidine solution for 30 seconds before and after dental scaling; subgingival irrigation of all periodontal pockets with with 1% chlorhexidine solution; daily rinsing with 0.2% chlorhexidine solution (15mL/30 seconds/2 times a day	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.
Experimental: Obesity II full-mouth disinfection; Obesity II (body mass index 35.0 - 39.9 kg/m2) individuals with chronic periodontitis; Full-mouth manual scaling and root planing within 24 hours; tongue cleaning with chlorhexidine gel 1% for 1 minute; tonsils disinfection with chlorhexidine spray 0.2%; rinsing with 15mL of 0.2% chlorhexidine solution for 30 seconds before and after dental scaling; subgingival irrigation of all periodontal pockets with with 1% chlorhexidine solution; daily rinsing with 0.2% chlorhexidine solution (15mL/30 seconds/2 times a day	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.
Experimental: Obesity III full-mouth disinfection; Obesity III (body mass index ≥ 40.0 kg/m2) individuals with chronic periodontitis; Full-mouth manual scaling and root planing within 24 hours; tongue cleaning with chlorhexidine gel 1% for 1 minute; tonsils disinfection with chlorhexidine spray 0.2%; rinsing with 15mL of 0.2% chlorhexidine solution for 30 seconds before and after dental scaling; subgingival irrigation of all periodontal pockets with with 1% chlorhexidine solution; daily rinsing with 0.2% chlorhexidine solution (15mL/30 seconds/2 times a day	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic effects	Glycemic blood levels.	Changes in in glycemic levels from baseline to 6 months.
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.
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.

Collaborators and Investigators

• Sponsor: University of Taubate
• Investigators: Principal Investigator: Jose R Cortelli, PhD, Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2017
• Primary Completion (Actual): July 28, 2017
• Study Completion (Actual): December 28, 2017

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 19, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; Therapeutics; Periodontitis; Chlorhexidine
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Obesity; Periodontitis; Obesity, Morbid; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: UTaubate

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No