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Understanding, Modulation and Memorization of Indicators Associated to Peri-implantitis
Understanding, Modulation and Memorization of Indicators Associated to Peri-implantitis: A Randomized Controlled Trial
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Badajoz, Spanje, 06011
- Centro de Implantologia Cirugia Oral y Maxilofacial
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Test group1 - Leaflet with visual aid
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.
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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.
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Experimenteel: Test group2 - Leaflet with visual aid (L-NVA)
Information concerning etiology, prevalence, risk indicators and preventive measures of peri-implantitis were included.
Relevant scientific bibliography supported the statements.
No pictograms were supplemented.
|
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.
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Geen tussenkomst: • Control group - No leaflet (NL)
Only verbal information was provided to the patient during initial interview.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Understanding
Tijdsspanne: Baseline
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Questionnaire
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Baseline
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Memorisation
Tijdsspanne: 3 month follow-up
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Questionnaire
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3 month follow-up
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Memorisation
Tijdsspanne: 6 month follow-up
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Questionnaire
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6 month follow-up
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Medewerkers en onderzoekers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 18002909-18/9/19
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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Klinische onderzoeken op Peri-implantitis
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Center of Implantology, Oral and Maxillofacial...WervingPeri-implantitis en peri-implantaire mucositisSpanje
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King Abdullah University HospitalJordan University of Science and TechnologyVoltooidPeri-implantitis en peri-implantaire mucositisJordanië
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Rambam Health Care CampusVoltooidTandimplantaten, peri-implantitis, rokenIsraël
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University of ValenciaVoltooidVroege apicale peri-implantitis
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University of GuarulhosActief, niet wervendPeri-implantitis en peri-implantaire mucositis | Peri-implantitis en systemische ontstekingBrazilië
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Istanbul Medipol University HospitalAnkara University; Ankara Medipol University; Lokman Hekim UniversityVoltooidPeri-implantitis | Peri-implantaat gezondheid | Peri-implantaatmucositisTurkije (Türkiye)
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Recep Tayyip Erdogan UniversityNog niet aan het wervenPeri-implantitis | Peri-implantaatmucositis
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University of Campinas, BrazilActief, niet wervendPeri-implantitis en peri-implantaire mucositisBrazilië
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University of ZagrebNog niet aan het wervenPeri-implantaire mucositis | Peri-implantitis en peri-implantaire mucositis | Peri-implantaat Gezondheid | Peri-implantaire ziekten | Peri-implantaat botverlies
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Abant Izzet Baysal UniversityVoltooidPeri-implantitis | Peri-implantaire mucositis | Peri-implantaat GezondheidTurkije (Türkiye)