Patient's Perception of Complications in Implantology.

Completed

• Conditions: Dental Implant Failed; Dental Prosthesis Failure
• Interventions: Procedure: Dental implant treatment

• Registration Number: NCT04870658
• Lead Sponsor: Aula Dental Avanzada

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.

Study Timeline

• Study Start: 2021-01-21
• Study First Submitted: 2021-04-25
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-05-03
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Complication	Dental implant treatment	Any patients with biological or mechanical complication in dental implant treatment.

Primary Outcome Measures

Name	Time	Method
Patient´s pain perception	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	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	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	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)	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".

Trial Locations

Locations (1)

Clínica Dental Esteve; 🇪🇸 Alicante, Spain