Patient's Perception of Complications in Implantology.

April 6, 2023 updated by: Guillem Esteve-Pardo, Aula Dental Avanzada

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

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

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

408

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03001
        • Clínica Dental esteve

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

All the patients who present dental implant complication in any of the center in the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Complication
Any patients with biological or mechanical complication in dental implant treatment.
Procedure: Dental implant treatment
Patients who receive one o more dental implant treatment to restore oral function.
Other Names:
  • Dental implant prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
Day 0
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".
Day 0
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".
Day 0
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".
Day 0
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".
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of the patient
Time Frame: Day 0
Perception of the patients for the complication event by questionnaire
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aula Dental Avanzada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

April 25, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMPLI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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