Patient’s Perception of Complications in Implantology.

Overview

To assess the influence that the complications of implant treatment have on the patient's perception and satisfaction on treatment.

Full Title of Study: “Patient’s Perception of Complications in Implantology. Prospective Multicenter Study.”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: September 1, 2022

Detailed Description

The study is carried out in 5 dental centers with similar socio-professional characteristics. The perception of patients with complications in implantology will be evaluated using a questionnaire. All patients who present some type of complication in a dental treatment with implants will be included. Patients will be included both if they are aware of the complication, that is, they come to the consultation for it, and patients who are diagnosed with a complication in a routine check-up. Patients will be informed of the complication and before explaining the treatment possibilities, their inclusion in the study will be formalized by signing the Informed Consent document. Subsequently, they must fill out a questionnaire consisting of 5 questions about their perception of the complication and its influence on their quality of life. The researcher will record the technical data of the implant treatment as well as the patient's responses in the Data Table. After collecting a sufficient number of data, around 400 patients, the collaborating researchers will send their corresponding data tables to the main researcher who will be in charge of the statistical analysis together with obtaining the results.

Interventions

  • Procedure: Dental implant treatment
    • Patients who receive one o more dental implant treatment to restore oral function.

Arms, Groups and Cohorts

  • Complication
    • Any patients with biological or mechanical complication in dental implant treatment.

Clinical Trial Outcome Measures

Primary Measures

  • Patient´s pain perception
    • Time Frame: Day 0
    • The degree of pain perceived by the patient after the onset of the complication by Numeric Rating Scale (NRS) form 0 to 10, being 0 “No pain” and 10 “Very painful”.
  • Functional impairment
    • Time Frame: Day 0
    • The impact of complication on functional impairment by Numeric Rating Scale (NRS) form 0 to 10, being 0 “Not affected” and 10 “Very affected”.
  • Degree of Concern
    • Time Frame: Day 0
    • The degree of concern that the complication generates in the patient by Numeric Rating Scale (NRS) form 0 to 10, being 0 “Not concerned” and 10 “Very concerned”.
  • Quality of life (QoL)
    • Time Frame: Day 0
    • Patient perception of the impact of the complication on their quality of life by Numeric Rating Scale (NRS) form 0 to 10, being 0 “Not affected” and 10 “Very affected”.
  • Degree of Confidence
    • Time Frame: Day 0
    • The impact that the complication has had on the patient’s confidence in dental implant treatment using a numerical rating scale (NRS) from 0 to 10, with 0 being “Confident that they will not receive any further dental implant treatment” and 10 being “Confident that they will”.

Participating in This Clinical Trial

Inclusion Criteria

Patients form 18 to 95 years old. Patients with dental implants supporting one o more implant prosthesis. Patients presenting one treatment complication affecting either dental implant or implant prothesis. Exclusion Criteria:

Patients who does not accept informed consent and do not want to fill the questionnaire. Patients with cognitive impairment. Patients under psychiatric treatment.

Gender Eligibility: All

Male or female.

Minimum Age: 18 Years

Maximum Age: 95 Years

Investigator Details

  • Lead Sponsor
    • Aula Dental Avanzada
  • Provider of Information About this Clinical Study
    • Principal Investigator: Guillem Esteve-Pardo, Principal Investigator – Aula Dental Avanzada
  • Overall Official(s)
    • Guillem Esteve-Pardo, DDS, Principal Investigator, Aula Dental Avanzada

References

Brunello G, Gervasi M, Ricci S, Tomasi C, Bressan E. Patients' perceptions of implant therapy and maintenance: A questionnaire-based survey. Clin Oral Implants Res. 2020 Oct;31(10):917-927. doi: 10.1111/clr.13634. Epub 2020 Jul 26.

Derks J, Hakansson J, Wennstrom JL, Klinge B, Berglundh T. Patient-reported outcomes of dental implant therapy in a large randomly selected sample. Clin Oral Implants Res. 2015 May;26(5):586-91. doi: 10.1111/clr.12464. Epub 2014 Aug 14.

Insua A, Monje A, Wang HL, Inglehart M. Patient-Centered Perspectives and Understanding of Peri-Implantitis. J Periodontol. 2017 Nov;88(11):1153-1162. doi: 10.1902/jop.2017.160796. Epub 2017 May 26.

Karlsson K, Derks J, Wennstrom JL, Petzold M, Berglundh T. Occurrence and clustering of complications in implant dentistry. Clin Oral Implants Res. 2020 Oct;31(10):1002-1009. doi: 10.1111/clr.13647. Epub 2020 Sep 4.

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