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Treatment of Periodontitis in Obese Individuals (CLIMBEO)

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ClinicalTrials.gov Identifier: NCT03103204
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Jose Roberto Cortelli, University of Taubate

Brief 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.

Condition or disease Intervention/treatment Phase
Obese Obesity, Morbid Periodontitis Combination Product: One-stage full-mouth disinfection with chlorhexidine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical, Microbial and Biochemistry Evaluation of Obese Individuals Submitted to One-stage Full-mouth Disinfection. A Clinical Control Parallel Study
Actual Study Start Date : January 21, 2017
Estimated Primary Completion Date : July 28, 2017
Estimated Study Completion Date : December 28, 2017


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.





Primary Outcome Measures :
  1. Periodontal clinical efficacy [ Time Frame: Changes in periodontal pocket depth measurements from baseline to 6 months ]
    Improvements in periodontal pocket depth (mm) overtime and comparisons among groups at 6 months after treatment

  2. Periodontal clinical efficacy [ Time Frame: Changes in clinical attachment measurements from baseline to 6 months ]
    Improvements in clinical attachment level (mm) overtime and comparisons among groups at 6 months after treatment


Secondary Outcome Measures :
  1. Antimicrobial efficacy [ Time Frame: Changes in total bacterial levels from baseline to 6 months ]
    Reductions in total bacterial levels and levels of target bacterial species overtime and comparisons among groups at 6 months after treatment

  2. Antimicrobial efficacy [ Time Frame: Changes in bacterial levels from baseline to 6 months ]
    Reductions in Treponema denticola, Porphyromonas gingivalis, Tannerella forsythia, Aggregatibacter actinomycetemcomitans levels overtime and comparisons among groups at 6 months after treatment

  3. Oral safety and tolerability [ Time Frame: Changes in salivary nitrite levels from baseline to 6 months ]
    Maintenance of salivary nitrite levels overtime and comparisons among groups at 6 months after treatment

  4. Impact on quality of life [ Time Frame: 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 ]
    Improvements in Oral health and quality of life - United Kingdom questionnaire scores overtime and comparisons among groups at 6 months after treatment

  5. Impact on quality of life [ Time Frame: Changes in scores (Likert scale ranging from 0 to 56 points) of Oral impacts on daily performance questionnaire from baseline to 6 months ]
    Improvements in Oral impacts on daily performance questionnaire scores overtime and comparisons among groups at 6 months after treatment


Other Outcome Measures:
  1. Systemic effects [ Time Frame: Changes in in glycemic levels from baseline to 6 months. ]
    Glycemic blood levels.

  2. Systemic effects [ Time Frame: Changes in blood levels of high density lipoprotein-cholesterol, low density lipoprotein -cholesterol and very low density lipoprotein - fractions from baseline to 6 months. ]
    Blood levels of high density lipoprotein-cholesterol, low density lipoprotein -cholesterol, very low density lipoprotein - fractions levels parameters.

  3. Systemic effects [ Time Frame: Changes in blood counts of white cells, red cells and platelets from baseline to 6 months. ]
    Blood counts of white cells, red cells and platelets.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103204


Contacts
Contact: Jose R Cortelli, PhD +5512996768618 jrcortelli@uol.com.br
Contact: Sheila C Cortelli, PhD +5512996676115 cavalcacortelli@uol.com.br

Locations
Brazil
University of Taubate Recruiting
Taubate, Sao Paulo, Brazil, 12020330
Contact: Felipe S Peralta, MSc    +554730251353    felipesilvaperalta@hotmail.com   
Sponsors and Collaborators
University of Taubate
Investigators
Principal Investigator: Jose R Cortelli, PhD Associate professor

Responsible Party: Jose Roberto Cortelli, Head of Periodontics Department, University of Taubate
ClinicalTrials.gov Identifier: NCT03103204     History of Changes
Other Study ID Numbers: UTaubate
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jose Roberto Cortelli, University of Taubate:
Obesity
Periodontitis
Therapeutics
Chlorhexidine

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Nutrition Disorders
Periodontitis
Obesity, Morbid
Obesity
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents