Mechanical-chemical Gingival Therapy in Diabetics and/or Obese
Condition: Gingivitis; Diabetes; Obesity
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): Ultrason Essential oils rinse; Ultrason Placebo rinse
Intervention type(s): Other; Other
Intervention description(s): 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%.; 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.
Other intervention name(s): Listerine total care; Placebo mouth rinse manipulated for the present study.
Intervention MeSH terms: Listerine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment