Clinical trial NCT04870658: Patient's Perception of Complications in Implantology.
Official title: Patient's Perception of Complications in Implantology. Prospective Multicenter Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implant Failed
Dental Prosthesis Failure
Keywords: Complication
Implant dentistry
Lead sponsor: Aula Dental Avanzada
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All the patients who present dental implant complication in any of the center in the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient´s pain perception
timeFrame: Day 0
measure: Functional impairment
timeFrame: Day 0
measure: Degree of Concern
timeFrame: Day 0
measure: Quality of life (QoL)
timeFrame: Day 0
measure: Degree of Confidence
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Clínica Dental Esteve
Study officials:
affiliation: Aula Dental Avanzada
name: Guillem Esteve-Pardo, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.