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Clinical Trials/NCT04870658
NCT04870658
Completed
Not Applicable

Patient's Perception of Complications in Implantology. Prospective Multicenter Study.

Aula Dental Avanzada1 site in 1 country408 target enrollmentJanuary 21, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implant Failed
Sponsor
Aula Dental Avanzada
Enrollment
408
Locations
1
Primary Endpoint
Patient´s pain perception
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 21, 2021
End Date
September 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Aula Dental Avanzada
Responsible Party
Principal Investigator
Principal Investigator

Guillem Esteve-Pardo

Principal Investigator

Aula Dental Avanzada

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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".

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".

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".

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".

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".

Study Sites (1)

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