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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

Studieöversikt

Studietyp

Interventionell

Inskrivning (Faktisk)

99

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Badajoz, Spanien, 06011
        • Centro de Implantologia Cirugia Oral y Maxilofacial

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
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.
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.
Inget ingripande: • Control group - No leaflet (NL)
Only verbal information was provided to the patient during initial interview.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Understanding
Tidsram: Baseline
Questionnaire
Baseline
Memorisation
Tidsram: 3 month follow-up
Questionnaire
3 month follow-up
Memorisation
Tidsram: 6 month follow-up
Questionnaire
6 month follow-up

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

10 februari 2018

Primärt slutförande (Faktisk)

9 juni 2021

Avslutad studie (Faktisk)

9 juni 2021

Studieregistreringsdatum

Först inskickad

29 augusti 2020

Först inskickad som uppfyllde QC-kriterierna

2 september 2020

Första postat (Faktisk)

10 september 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 september 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 september 2021

Senast verifierad

1 september 2021

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 18002909-18/9/19

Plan för individuella deltagardata (IPD)

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Obeslutsam

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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