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Mechanical-chemical Gingival Therapy in Diabetics and/or Obese (MCGTDO)

Primary Purpose

Gingivitis, Diabetes, Obesity

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Ultrason Essential oils rinse
Ultrason Placebo rinse
Sponsored by
University of Taubate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • plaque-related gingivitis (with no radiographic evidence of periodontal bone resorption and a bleeding site rate of more than 30%)
  • periodontally healthy group (with no radiographic evidence of periodontal bone resorption and a bleeding site rate of less than 30%)
  • at least 20 natural teeth
  • diabetes group: controlled type II diabetes (with a blood glycated hemoglobin level between 6.5 and 7%) that was diagnosed at least 3 years but no more than 5 years prior to the study
  • normal salivary flow
  • obesity group: obesity level I - body mass index: 30 to 34.99 kg/m2 or obesity level II - body mass index: 35 to 39.99 kg/m2
  • normal weight group: body mass index: 20 to 24.99 kg/m2;

Exclusion Criteria:

  • gingival overgrowth
  • orthodontic devices
  • extended prosthetic fixed devices
  • removable partial dentures or overhanging restorations
  • systemic diseases or other conditions that could influence the periodontal status (other than diabetes within the diabetic group)
  • overweight - BMI 25 to 29.99 kg/m2 and obesity level III or morbid obesity - ≥ 40 kg/m2 (obesity group) - alcohol abuse
  • pregnancy or breast-feeding
  • history of sensitivity or suspected allergies following the use of oral hygiene products
  • the need for antibiotic prophylaxis; antibiotics and/or anti-inflammatory drug use in the six months prior to the beginning of the study
  • regular use of chemotherapeutic antiplaque/antigingivitis products
  • periodontal treatment performed within six months prior to study initiation
  • unwillingness to return for follow-up

Sites / Locations

  • University of Taubate - Nucleus of periodontal research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ultrason Essential oils rinse

Ultrason Placebo rinse

Arm Description

Ultrasonic debridement followed by twice daily home use of an essential-oils mouth rinse (20mL, 30 seconds for each rinse) for 3 months

Ultrasonic debridement followed by twice daily home use of a placebo rinse (20mL, 30 seconds for each rinse) for 3 months

Outcomes

Primary Outcome Measures

plaque and gingival indices
percentage of dental surfaces showing mild (scores 0,1), moderate (scores 2,3) or severe (scores 4,5) amounts of dental plaque or showing gingival bleeding (positive or negative) after gentle probing

Secondary Outcome Measures

Full Information

First Posted
April 9, 2014
Last Updated
April 23, 2014
Sponsor
University of Taubate
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02123563
Brief Title
Mechanical-chemical Gingival Therapy in Diabetics and/or Obese
Acronym
MCGTDO
Official Title
Evaluation of Mechanical-chemical Gingival Therapy in Diabetic, Obese or Diabese Subjects: Quantitative and Qualitative Analysis of Local and General Aspects.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Taubate
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Diabetes and obesity affect many people in different countries. Similarly, millions of people have some type of gum disease such as gingivitis. The present study was conducted to clarify if systemic conditions such as diabetes and obesity could impair the response to gingivitis treatment. Subjects with gum disease showing diabetes type II (from 40 to 50 subjects), slight to moderate obesity (from 40 to 50 subjects) or its combination (from 40 to 50 subjects) were selected for the present study. In addition normal-weight subjects with gum disease (from 40 to 50 subjects) besides a group without gum disease (from 40 to 50 subjects) were selected for comparisons. After verbal and written explanations about the study, subjects who matched study criteria and who signed the informed consent form underwent full oral examinations in two separate visits. In the first visit, after a clinical examination to verify the levels of gingival inflammation and the accumulated amounts of dental plaque, the bone height was determined by X-Ray examinations. Bad breath was also evaluated by a chair-side apparatus. Additional laboratorial examinations included a) quantification of bacteria that cause gum disease from dental plaque samples, b) quantification of inflammatory products from gingival fluid sampling and c) quantification of produced saliva. Self-report questionnaires were used to check the impact of oral condition and treatment of gum disease in quality of life and individual daily performance. These examinations were repeated 3 months after dental treatment. All subjects received ultrasonic dental prophylaxis for cleaning their teeth. Based on systemic/oral conditions each group rinsed either an essential-oils containing mouth rinse or a placebo rinse. First rinse was supervised and the other ones were performed at home twice a day for three months. Each participant also received a toothbrush, a dental floss and a fluoride toothpaste monthly after oral hygiene instructions. Adherence to the treatment and occurrence of undesirable side effects were monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Diabetes, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrason Essential oils rinse
Arm Type
Experimental
Arm Description
Ultrasonic debridement followed by twice daily home use of an essential-oils mouth rinse (20mL, 30 seconds for each rinse) for 3 months
Arm Title
Ultrason Placebo rinse
Arm Type
Placebo Comparator
Arm Description
Ultrasonic debridement followed by twice daily home use of a placebo rinse (20mL, 30 seconds for each rinse) for 3 months
Intervention Type
Other
Intervention Name(s)
Ultrason Essential oils rinse
Other Intervention Name(s)
Listerine total care
Intervention Description
Test treatment strategy combined mechanical and chemical procedures. Mechanical procedures were: a) ultrasonic debridement to remove dental plaque, calculus and teeth staining; b) dental polishing and c) oral hygiene instructions related to brushing and flossing. Toothbrush, dental floss and fluoride dentifrice were monthly provided. Within the same visit participants performed at the study center the first supervised rinse. Other rinses were performed at home unsupervised. A diary card was used to register times of rinsing. Participants rinsed twice a day a commercially available non-prescription essential-oils solution (20mL, 30 seconds for each rinse) for 3 months. This solution is composed of eucalyptol 0.092%, menthol 0.042%, methyl salicylate 0.060%, thymol 0.064%, zinc chloride and sodium fluoride 0.0221%.
Intervention Type
Other
Intervention Name(s)
Ultrason Placebo rinse
Other Intervention Name(s)
Placebo mouth rinse manipulated for the present study.
Intervention Description
Comparative treatment strategy combined mechanical and chemical procedures. Mechanical procedures were: a) ultrasonic debridement to remove dental plaque, calculus and teeth staining; b) dental polishing and c) oral hygiene instructions related to brushing and flossing. Toothbrush, dental floss and fluoride dentifrice were monthly provided. Within the same visit participants performed at the study center the first supervised rinse. Other rinses were performed at home unsupervised. A diary card was used to register times of rinsing. Participants rinsed twice a day a placebo solution (20mL, 30 seconds for each rinse) for 3 months.
Primary Outcome Measure Information:
Title
plaque and gingival indices
Description
percentage of dental surfaces showing mild (scores 0,1), moderate (scores 2,3) or severe (scores 4,5) amounts of dental plaque or showing gingival bleeding (positive or negative) after gentle probing
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: plaque-related gingivitis (with no radiographic evidence of periodontal bone resorption and a bleeding site rate of more than 30%) periodontally healthy group (with no radiographic evidence of periodontal bone resorption and a bleeding site rate of less than 30%) at least 20 natural teeth diabetes group: controlled type II diabetes (with a blood glycated hemoglobin level between 6.5 and 7%) that was diagnosed at least 3 years but no more than 5 years prior to the study normal salivary flow obesity group: obesity level I - body mass index: 30 to 34.99 kg/m2 or obesity level II - body mass index: 35 to 39.99 kg/m2 normal weight group: body mass index: 20 to 24.99 kg/m2; Exclusion Criteria: gingival overgrowth orthodontic devices extended prosthetic fixed devices removable partial dentures or overhanging restorations systemic diseases or other conditions that could influence the periodontal status (other than diabetes within the diabetic group) overweight - BMI 25 to 29.99 kg/m2 and obesity level III or morbid obesity - ≥ 40 kg/m2 (obesity group) - alcohol abuse pregnancy or breast-feeding history of sensitivity or suspected allergies following the use of oral hygiene products the need for antibiotic prophylaxis; antibiotics and/or anti-inflammatory drug use in the six months prior to the beginning of the study regular use of chemotherapeutic antiplaque/antigingivitis products periodontal treatment performed within six months prior to study initiation unwillingness to return for follow-up
Facility Information:
Facility Name
University of Taubate - Nucleus of periodontal research
City
Taubate
State/Province
SP
ZIP/Postal Code
12020330
Country
Brazil

12. IPD Sharing Statement

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Mechanical-chemical Gingival Therapy in Diabetics and/or Obese

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