Understanding, Modulation and Memorization of Indicators Associated to Peri-implantitis
Condition: Peri-Implantitis
MeSH terms: Peri-Implantitis
Study type: Interventional

Summary: 
      Communication strategies are encouraged to enhance patients´ understanding of potential
      events related to implant therapy such as peri-implantitis. Moreover, it is key to provide
      accurate information to patients receiving dental implants to reduce false expectations and
      to minimize the alterations concerning satisfaction. Information leaflets based in the
      "health-belief model" proved efficiency in improving health judgments, decisions and
      behaviors, in particular when supplemented with visual aids. Hence, it was the purpose of the
      present study to test the effectiveness of different communication strategies to enhance and
      modulate the understanding and memorization of risk indicators associated to
      peri-implantitis.

      A prospective randomized controlled three-arm study is being conducted in accordance with the
      Declaration of Helsinki on human studies. Three groups are defined to test the hypothesis
      that visual aids improve the understanding, modulation and memorization of peri-implantitis
      and related indicators as follows:

        -  Test group1 - Leaflet with visual aid (L-VA): Information concerning etiology,
           prevalence, risk indicators and preventive measures of peri-implantitis were included
           (supplementary figure 1). Relevant scientific bibliography supported the statements.
           Along, pictograms were supplemented to display the prevalence of disease with and
           without the known indicator.

        -  Test group2 - Leaflet with visual aid (L-NVA): Information concerning etiology,
           prevalence, risk indicators and preventive measures of peri-implantitis were included
           (supplementary figure 2). Relevant scientific bibliography supported the statements. No
           pictograms were supplemented.

        -  Control group - No leaflet (NL): Only verbal information was provided to the patient
           during initial interview.

      Patients will be randomly assigned to the tests or control groups according to the last digit
      of their chart number. As such, patients with records ending 1-4, 4-7 and 8-0 were included
      in test group1, test group2 and control group, respectively. When reached the total sample
      size of any of the groups, patients were only recruited for the remaining groups to complete
      the total sample size. A questionnaire based on the "health-belief model" will be collected
      from every eligible patient at baseline, 3- and 6-month follow-up
    


Intervention name(s): Leatlet + visual aid (pictogram); Leaflet + no visual aid (no pictogram)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The questionnaires were collected at baseline (at the end of the initial interview and once the patients assigned within the test groups declared to have read the leaflet) at 3- and 6-month follow-up. The questionnaire included demographic data such as age, gender, civil status, occupation (coded according to the CNO-11(2010), presence of systemic disorder, smoking and number of implants. Moreover, data concerning history of periodontal disease and type of prosthesis were further documented and added to demographics.; The questionnaires were collected at baseline (at the end of the initial interview and once the patients assigned within the test groups declared to have read the leaflet) at 3- and 6-month follow-up. The questionnaire included demographic data such as age, gender, civil status, occupation (coded according to the CNO-11(2010), presence of systemic disorder, smoking and number of implants. Moreover, data concerning history of periodontal disease and type of prosthesis were further documented and added to demographics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention