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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started Jan 2017

Shorter than P25 for phase_4

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11 months study duration

Study Start

First participant enrolled

January 21, 2017

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed

23 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2017

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2017

Completed

Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

March 14, 2017

Last Update Submit

July 19, 2019

Conditions

Obese Obesity, Morbid Periodontitis

Keywords

ObesityPeriodontitisTherapeuticsChlorhexidine

Outcome Measures

Primary Outcomes (2)

Periodontal clinical efficacy
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
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 Outcomes (5)

Antimicrobial efficacy
Changes in total bacterial levels from baseline to 6 months
Antimicrobial efficacy
Changes in bacterial levels from baseline to 6 months
Oral safety and tolerability
Changes in salivary nitrite levels from baseline to 6 months
Impact on quality of life
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
Changes in scores (Likert scale ranging from 0 to 56 points) of Oral impacts on daily performance questionnaire from baseline to 6 months

Other Outcomes (3)

Systemic effects
Changes in in glycemic levels from baseline to 6 months.
Systemic effects
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
Changes in blood counts of white cells, red cells and platelets from baseline to 6 months.

Study Arms (5)

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