Treatment of Periodontitis in Obese Individuals (CLIMBEO)

July 19, 2019 updated by: Jose Roberto Cortelli, University of Taubate

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Changes in periodontal pocket depth measurements from baseline to 6 months
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
Changes in clinical attachment measurements from baseline to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Changes in total bacterial levels from baseline to 6 months
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
Changes in bacterial levels from baseline to 6 months
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
Changes in salivary nitrite levels from baseline to 6 months
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
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
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
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systemic effects
Time Frame: Changes in in glycemic levels from baseline to 6 months.
Glycemic blood levels.
Changes in in glycemic levels from baseline to 6 months.
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.
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
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.
Changes in blood counts of white cells, red cells and platelets from baseline to 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Taubate

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jose R Cortelli, PhD, Associate professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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