Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)

Browse trials for

• Gingivitis 590
• Dental Plaque 314

Keywords

• adolescent health
• dental plaque
• gingivitis
• cognitive change

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 150 is above the median of 64 across 478 interventional studies indexed under Gingivitis.

Lead sponsor

Howard University is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Study arms

• Experimental
  Test Group I

  A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush Cognitive behavioral intervention (CBI)

  Behavioral: Cognitive behavioral intervention · Other: Colgate smart toothbrush

• Active comparator
  Control group I

  A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush

  Other: Colgate smart toothbrush

• No intervention
  Control group II

  A commercially available fluoride toothpaste (1450 ppm F) A commercially available soft bristle toothbrush

Interventions

• BehavioralCognitive behavioral intervention

  A six-session CBI Intervention component will be used with the TEST GROUP I. This will examine a cognitive behavioral intervention designed to improve tooth brushing and oral hygiene. The components include oral health education, values-based activities, motivational interviewing, goal setting, problem solving skills, cognitive restructuring, verbal reinforcement and stress management.

• OtherColgate smart toothbrush

  A Colgate smart toothbrush that provides the user with details on toothbrushing habits and frequency

Primary outcomes

1. Gingival inflammation

   A Löe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scorable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scorable surface and dividing that number by the total number of surfaces scored. Scores Criteria 0 Absence of inflammation 1. Mild inflammation- Slight change in color and mild edema with little change in texture. No bleeding on probing. 2. Moderate inflammation- moderate glazing, redness, edema and hypertrophy. Bleeding on probing. 3. Severe inflammation- Marked redness, hypertrophy, edema and ulceration. Tendency for spontaneous bleeding.

   Time frame: All outcomes will be measured at baseline, at1 month, 3 months and at 6 months

Secondary outcomes

1. Plaque scores

   Mean plaque index scores will be computed for each subject. Each tooth is scored in six areas: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Whole mouth within subject mean scores will be computed as follows: Total plaque score for all scoring sites divided by total number of scoring sites

   Time frame: All outcomes will be measured at baseline, 1 month, 3 months and at 6 months

2. Knowledge assessment

   Knowledge will be assessed using 19 item scale previously used by the researchers Enrolled subjects will complete a questionnaire on oral health knowledge, attitudes, and practices including: frequency of brushing and flossing, knowledge, oral health values scale, self-efficacy and motivation. The outcome will be assessed using a 19-item multiple choice survey previously used in Colgate-sponsored research protocols. A six-item oral health self-efficacy scale will be used to measure participant self-reported confidence in their ability to carry out an oral health care routine. Lastly, motivation to engage in recommended oral hygiene behavior will be assessed with a single item 1analog scale (i.e., "How important is it to follow guidelines for brushing twice per day and flossing once per day, from 0 "not important at all" to 10 "most important.")

   Time frame: All outcomes will be measured at baseline, 1 month, 3 months and at 6 months

3. Efficacy assessment

   Efficacy will be assessed using a validated 6 item oral health self-efficacy scale

   Time frame: All outcomes will be measured at baseline, 1 month, 3months and at 6 months

4. Motivation assessment

   Motivation will be assessed using a single item 10-point visual analog scale

   Time frame: All outcomes will be measured at baseline, 1 month, 3months and at 6 months

Individual participant data

Plan to share: No — There is no plan to make individual data available to other researchers