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OpenTrials
Completed

NCT Number: NCT04870658

Patient's Perception of Complications in Implantology.

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

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Key information

Conditions

Dental Implant Failed Dental Prosthesis Failure

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica Dental Esteve

Alicante, 03001, Spain

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dental implant treatment

Procedure

Patients who receive one o more dental implant treatment to restore oral function.

Other names: Dental implant prosthesis

Primary outcomes

  1. 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".

  2. 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".

  3. 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".

  4. 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".

  5. 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".

Sponsors and collaborators

Lead sponsor

Aula Dental Avanzada

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 3, 2021
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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