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Completed

NCT Number: NCT03103204

Treatment of Periodontitis in Obese Individuals

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Taubate

Taubaté, São Paulo, 12020330, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One-stage full-mouth disinfection with chlorhexidine

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Taubate

Other

Registry information

Official study title

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

Acronym: CLIMBEO

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 6, 2017
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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