Dental Implant FailedNCT04870658
Patient's Perception of Complications in Implantology.
An observational study of Dental Implant Failed and Dental Prosthesis Failure, run by Aula Dental Avanzada at 1 site in Spain.
Trial summary
To assess the influence that the complications of implant treatment have on the patient's perception and satisfaction on treatment. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Dental Implant Failed, Dental Prosthesis Failure
- What is being tested?
- Dental implant treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 408 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jan 2021to 1 Sep 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Adult, Older adult
Study population: All the patients who present dental implant complication in any of the center in the study.
Who may be able to join
- 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.
Who cannot join
- Patients who does not accept informed consent and do not want to fill the questionnaire.
- Patients with cognitive impairment. Patients under psychiatric treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Implant Failed, Dental Prosthesis Failure
- Being tested
- Dental implant treatment
- Keywords
- Complication, Implant dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant treatmentProcedure or surgery
Also called Dental implant prosthesis
Patients who receive one o more dental implant treatment to restore oral function.
| Study group | Role | What they receive |
|---|---|---|
| Complication | Any patients with biological or mechanical complication in dental implant treatment. Receives: Procedure: Dental implant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start21 Jan 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 408 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Aula Dental Avanzada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillem Esteve-Pardo, Aula Dental Avanzada
- Investigators
- Guillem Esteve-Pardo, DDS, Principal investigator, Aula Dental Avanzada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870658
- Sponsor's protocol ID
- COMPLI
- Status last verified
- Apr 2023
- First submitted
- 25 Apr 2021
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32645229Derks 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.
PubMed 25123298Insua 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.
PubMed 28548884Karlsson 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.
PubMed 32794289
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient's Perception of Complications in Implantology. Prospective Multicenter Study.
- ClinicalTrials.gov ID
- NCT04870658
- Acronym / sponsor ID
- COMPLI
- Conditions
- Dental Implant Failed, Dental Prosthesis Failure
- Keywords
- Complication, Implant dentistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Aula Dental AvanzadaUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complication | – | Procedure: Dental implant treatmentAny patients with biological or mechanical complication in dental implant treatment. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All the patients who present dental implant complication in any of the center in the study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who does not accept informed consent and do not want to fill the questionnaire.
- Patients with cognitive impairment. Patients under psychiatric treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental implant treatmentAlso: Dental implant prosthesisPatients who receive one o more dental implant treatment to restore oral function. | Procedure or surgery | Complication |
Primary outcome
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".
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".
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".
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".
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Background: PubMed 32645229Brunello 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.
- Background: PubMed 25123298Derks 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.
- Background: PubMed 28548884Insua 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.
- Background: PubMed 32794289Karlsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillem Esteve-Pardo, DDS principal investigator
Aula Dental Avanzada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implant Failed and Dental Prosthesis Failure, run by Aula Dental Avanzada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient´s pain perception (time frame: Day 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04870658, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.