NCT04870658

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

1.6 years

First QC Date

April 25, 2021

Last Update Submit

April 6, 2023

Conditions

Dental Implant FailedDental Prosthesis Failure

Keywords

ComplicationImplant dentistry

Outcome Measures

Primary Outcomes (5)

  • Patient´s pain perception

    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

    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

    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)

    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

    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

Study Arms (1)

Complication

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

Procedure: Dental implant treatment

Interventions

Dental implant treatmentPROCEDURE

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

Also known as: Dental implant prosthesis
Complication

Eligibility Criteria

Age18 Years - 95 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale or female.
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Dental Esteve

Alicante, 03001, Spain

Location

Related Publications (4)

  • 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.

    PMID: 32645229BACKGROUND

  • 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.

    PMID: 25123298BACKGROUND

  • 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.

    PMID: 28548884BACKGROUND

  • 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.

    PMID: 32794289BACKGROUND

Study Officials

  • Guillem Esteve-Pardo, DDS

    Aula Dental Avanzada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2021

First Posted

May 3, 2021

Study Start

January 21, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

April 10, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)