- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04543604
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
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Badajoz, Spanien, 06011
- Centro de Implantologia Cirugia Oral y Maxilofacial
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
|
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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Experimentell: 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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Inget ingripande: • Control group - No leaflet (NL)
Only verbal information was provided to the patient during initial interview.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Understanding
Tidsram: Baseline
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Questionnaire
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Baseline
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Memorisation
Tidsram: 3 month follow-up
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Questionnaire
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3 month follow-up
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Memorisation
Tidsram: 6 month follow-up
|
Questionnaire
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6 month follow-up
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Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 18002909-18/9/19
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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