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

Peri-Implantitis Clinical Trial

Official title:

Understanding, Modulation and Memorization of Indicators Associated to Peri-implantitis: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04543604
• Other study ID #: 18002909-18/9/19
• Status: Completed
• Phase: N/A
• Start date: February 10, 2018
• Est. completion date: June 9, 2021

Study information

• Verified date: September 2021
• Source: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 9, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

The following inclusion criteria were applied: partially or completely edentulous patients aged 18-80 years and rehabilitated with implant-supported, single-crown fixed prostheses or implant-supported overdentures; smokers or non-smokers; absence of infectious disease at the time of implant placement; and absence of systemic disorders or medications known to alter bone metabolism. Subjects were excluded if they were pregnant; presented uncontrolled medical conditions or diseases (i.e., diabetes mellitus with HbA1c level >8); or presented zygomatic or pterygoid implants. Patients with treated peri-implantitis/mucositis were likewise excluded.

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Behavioral:
• Leatlet + visual aid (pictogram)
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.
• Leaflet + no visual aid (no pictogram)
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.

Locations

Country	Name	City	State
Spain	Centro de Implantologia Cirugia Oral y Maxilofacial	Badajoz

Sponsors (1)

Lead Sponsor	Collaborator
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Understanding	Questionnaire	Baseline
Primary	Memorisation	Questionnaire	3 month follow-up
Primary	Memorisation	Questionnaire	6 month follow-up