Patient's Perception of Complications in Implantology.

Dental Implant Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04870658
• Other study ID #: COMPLI
• Status: Completed
• Start date: January 21, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: April 2023
• Source: Aula Dental Avanzada
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implant Failed
• Dental Prosthesis Failure
• Prosthesis Failure

Intervention

Procedure:
• Dental implant treatment
Patients who receive one o more dental implant treatment to restore oral function.

Locations

Country	Name	City	State
Spain	Clínica Dental Esteve	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Aula Dental Avanzada

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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