NCT04543604

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

Completed NA Last updated 10 September 2021

What this trial tests

NA trial testing Leatlet + visual aid (pictogram) in Peri-Implantitis in 99 participants. Completed in 9 June 2021.

Timeline

10 February 2018

Primary endpoint
9 June 2021

9 June 2021

Quick facts

Lead sponsor	Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	99
Start date	10 February 2018
Primary completion	9 June 2021
Estimated completion	9 June 2021
Sites	1 location across Spain

Drugs / interventions tested

• Leatlet + visual aid (pictogram)
• Leaflet + no visual aid (no pictogram)

Conditions studied

• Peri-Implantitis — all drugs for Peri-Implantitis →

Sponsor

Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain — full company profile →

Who can join

Adults 18 to 80, any sex, with Peri-Implantitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comprehension and recall of information about factors associated with peri-implantitis: A randomized controlled trial.
   Monje A, Pérez A, Vera-Rodriguez M, Nart J, et al · · 2022 · cited 1× · PMID 33949680 · DOI 10.1002/jper.21-0018