ObesePhase 4CLIMBEONCT03103204
Treatment of Periodontitis in Obese Individuals
A Phase 4 study testing One-stage full-mouth disinfection with chlorhexidine in people with Obese and Obesity, Morbid, run by University of Taubate at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese, Obesity, Morbid, Periodontitis
- What is being tested?
- One-stage full-mouth disinfection with chlorhexidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Jan 2017to 28 Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Moderate to advanced generalized chronic periodontitis
- Body mass index: > 18.5 kg/m2
- Minimum of 12 natural teeth
- Smokers, non-smokers or former-smokers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obese, Obesity, Morbid, Periodontitis
- Being tested
- One-stage full-mouth disinfection with chlorhexidine
- Keywords
- Obesity, Periodontitis, Therapeutics, Chlorhexidine
- Medical subject headings
- Obesity, Obesity, Morbid, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-stage full-mouth disinfection with chlorhexidineCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Normal weight full-mouth disinfection | Experimental | * 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 Receives: Combination Product: One-stage full-mouth disinfection with chlorhexidine |
| Overweight full-mouth disinfection | Experimental | * 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 Receives: Combination Product: One-stage full-mouth disinfection with chlorhexidine |
| Obesity I full-mouth disinfection | Experimental | * 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 Receives: Combination Product: One-stage full-mouth disinfection with chlorhexidine |
| Obesity II full-mouth disinfection | Experimental | * 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 Receives: Combination Product: One-stage full-mouth disinfection with chlorhexidine |
| Obesity III full-mouth disinfection | Experimental | * 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 Receives: Combination Product: One-stage full-mouth disinfection with chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal clinical efficacy
Improvements in periodontal pocket depth (mm) overtime and comparisons among groups at 6 months after treatment
Measured: 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
Measured: Changes in clinical attachment measurements from baseline to 6 months
Secondary outcomes (5)
Antimicrobial efficacy
Reductions in total bacterial levels and levels of target bacterial species overtime and comparisons among groups at 6 months after treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Changes in scores (Likert scale ranging from 0 to 56 points) of Oral impacts on daily performance questionnaire from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start21 Jan 2017
- Primary completion28 Jul 2017
- Study completion28 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Taubate
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Roberto Cortelli, University of Taubate
- Investigators
- Jose R Cortelli, PhD, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103204
- Sponsor's protocol ID
- UTaubate
- Acronym
- CLIMBEO
- Status last verified
- Jul 2019
- First submitted
- 14 Mar 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Microbial and Biochemistry Evaluation of Obese Individuals Submitted to One-stage Full-mouth Disinfection. A Clinical Control Parallel Study
- ClinicalTrials.gov ID
- NCT03103204
- Acronym / sponsor ID
- CLIMBEO / UTaubate
- Conditions
- Obese, Obesity, Morbid, Periodontitis
- Keywords
- Obesity, Periodontitis, Therapeutics, Chlorhexidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of TaubateUniversity, hospital or other
- Study start
- 21 Jan 2017 (actual)
- Primary completion
- 28 Jul 2017 (actual)
- Study completion
- 28 Dec 2017 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal weight full-mouth disinfection | Experimental | Combination Product: One-stage full-mouth disinfection with chlorhexidine* 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 |
| Overweight full-mouth disinfection | Experimental | Combination Product: One-stage full-mouth disinfection with chlorhexidine* 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 |
| Obesity I full-mouth disinfection | Experimental | Combination Product: One-stage full-mouth disinfection with chlorhexidine* 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 |
| Obesity II full-mouth disinfection | Experimental | Combination Product: One-stage full-mouth disinfection with chlorhexidine* 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 |
| Obesity III full-mouth disinfection | Experimental | Combination Product: One-stage full-mouth disinfection with chlorhexidine* 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Moderate to advanced generalized chronic periodontitis
- Body mass index: > 18.5 kg/m2
- Minimum of 12 natural teeth
- Smokers, non-smokers or former-smokers
Key exclusion criteria (6 listed)
- 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) )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-stage full-mouth disinfection with chlorhexidineMechanical 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. | Combination product | Normal weight full-mouth disinfection, Obesity I full-mouth disinfection, Obesity II full-mouth disinfection, Obesity III full-mouth disinfection, Overweight full-mouth disinfection |
Primary outcome
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
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
5 secondary outcomes
Antimicrobial efficacy
Time frame: Changes in total bacterial levels from baseline to 6 months
Antimicrobial efficacy
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: No. IPD will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose R Cortelli, PhD principal investigator
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing One-stage full-mouth disinfection with chlorhexidine in people with Obese and Obesity, Morbid, run by University of Taubate at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal clinical efficacy (time frame: Changes in periodontal pocket depth measurements from baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.