Treatment of Periodontitis in Obese Individuals

NCT ID: NCT03103204

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-21
• Study Completion Date: 2017-12-28

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.

Conditions

Obese; Obesity, Morbid; Periodontitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

One-stage full-mouth disinfection with chlorhexidine

Intervention Type: COMBINATION_PRODUCT

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.

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

Group Type: EXPERIMENTAL

One-stage full-mouth disinfection with chlorhexidine

Intervention Type: COMBINATION_PRODUCT

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.

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

Group Type: EXPERIMENTAL

One-stage full-mouth disinfection with chlorhexidine

Intervention Type: COMBINATION_PRODUCT

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.

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

Group Type: EXPERIMENTAL

One-stage full-mouth disinfection with chlorhexidine

Intervention Type: COMBINATION_PRODUCT

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.

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

Group Type: EXPERIMENTAL

One-stage full-mouth disinfection with chlorhexidine

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Taubate

OTHER

Sponsor Role: lead

Responsible Party

Jose Roberto Cortelli

Head of Periodontics Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose R Cortelli, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Locations

University of Taubate

Taubaté, São Paulo, Brazil

Countries

Brazil

Other Identifiers

UTaubate

Identifier Type: -

Identifier Source: org_study_id