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

Primary Purpose

Peri-Implantitis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Leatlet + visual aid (pictogram)
Leaflet + no visual aid (no pictogram)
Sponsored by
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peri-Implantitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers
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.

Sites / Locations

  • Centro de Implantologia Cirugia Oral y Maxilofacial

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Test group1 - Leaflet with visual aid

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

• Control group - No leaflet (NL)

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Understanding
Questionnaire
Memorisation
Questionnaire
Memorisation
Questionnaire

Secondary Outcome Measures

Full Information

First Posted
August 29, 2020
Last Updated
September 9, 2021
Sponsor
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT04543604
Brief Title
Understanding, Modulation and Memorization of Indicators Associated to Peri-implantitis
Official Title
Understanding, Modulation and Memorization of Indicators Associated to Peri-implantitis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2018 (Actual)
Primary Completion Date
June 9, 2021 (Actual)
Study Completion Date
June 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group1 - Leaflet with visual aid
Arm Type
Experimental
Arm Description
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.
Arm Title
Test group2 - Leaflet with visual aid (L-NVA)
Arm Type
Experimental
Arm Description
Information concerning etiology, prevalence, risk indicators and preventive measures of peri-implantitis were included. Relevant scientific bibliography supported the statements. No pictograms were supplemented.
Arm Title
• Control group - No leaflet (NL)
Arm Type
No Intervention
Arm Description
Only verbal information was provided to the patient during initial interview.
Intervention Type
Behavioral
Intervention Name(s)
Leatlet + visual aid (pictogram)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Leaflet + no visual aid (no pictogram)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Understanding
Description
Questionnaire
Time Frame
Baseline
Title
Memorisation
Description
Questionnaire
Time Frame
3 month follow-up
Title
Memorisation
Description
Questionnaire
Time Frame
6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Centro de Implantologia Cirugia Oral y Maxilofacial
City
Badajoz
ZIP/Postal Code
06011
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33949680
Citation
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.
Results Reference
derived

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

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