Understanding, Modulation and Memorization of Indicators Associated to Peri-implantitis

NCT04543604 | Completed DMC

• 1 other identifier: 18002909-18/9/19
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (3)

• Understanding

  Questionnaire

  Baseline

• Memorisation

  Questionnaire

  3 month follow-up

• Memorisation

  Questionnaire

  6 month follow-up

Study Arms (3)

Test group1 - Leaflet with visual aid

EXPERIMENTAL

Information concerning etiology, prevalence, risk indicators and preventive measures of peri-implantitis were included. Relevant scientific bibliography supported the statements. Along, pictograms were supplemented to display the prevalence of disease with and without the known indicator.

Behavioral: Leatlet + visual aid (pictogram)

Test group2 - Leaflet with visual aid (L-NVA)

EXPERIMENTAL

Information concerning etiology, prevalence, risk indicators and preventive measures of peri-implantitis were included. Relevant scientific bibliography supported the statements. No pictograms were supplemented.

Behavioral: Leaflet + no visual aid (no pictogram)

• Control group - No leaflet (NL)

NO INTERVENTION

Only verbal information was provided to the patient during initial interview.

Interventions

Leatlet + visual aid (pictogram) BEHAVIORAL

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.

Test group1 - Leaflet with visual aid

Leaflet + no visual aid (no pictogram) BEHAVIORAL

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.

Test group2 - Leaflet with visual aid (L-NVA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain: lead

Study Sites (1)

Centro de Implantologia Cirugia Oral y Maxilofacial

Badajoz, 06011, Spain

Location

Related Publications (1)

• Monje A, Perez A, Vera-Rodriguez M, Nart J, Catena A, Petrova D. Comprehension and recall of information about factors associated with peri-implantitis: A randomized controlled trial. J Periodontol. 2022 Jan;93(1):89-99. doi: 10.1002/JPER.21-0018. Epub 2021 May 27.

  PMID: 33949680 DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Audiovisual Aids

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Educational Technology; Technology; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 10, 2020
• Study Start: February 10, 2018
• Primary Completion: June 9, 2021
• Study Completion: June 9, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

ES (1)