Dental TreatmentPEPABIONCT03538132
Patients' Perception on Bone Grafts
An observational study of Dental Treatment, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The goal of this study is to collect the patients' opinion about the different types of bone graft, to assess which are the most rejected by the patients and if the demographic variables (such as the gender or the age) and the level of education influence their decision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Treatment
- What is being tested?
- dental regenerative techniques
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2018to 30 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that had been treated in the "Centre de soins, d'enseignements et de recherches dentaires de l'Université de Montpellier" between December of 2017 and June of 2018.
Who may be able to join
- Adult (18 years old or more)
- Able to read and write
- Not under the influence of alcohol or drugs
- Had not previously undergone any surgery involving bone graft or bone augmentation.
Who cannot join
- Any patient who doesn't fullfill the inclusion criterias.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients' Perception on Bone Biomaterials Used in Dentistry : a Multicentric Study
The goal of this study is to collect the patients' opinion about the different types of bone graft, to assess which are the most rejected by the patients and if the demographic variables (such as the gender or the age) and the level of education influence their decision.
Read the detailed description
Nowadays, many procedures may need regenerative techniques. Some studies have already assessed the patients' opinion regarding soft tissue grafts, some investigators have centered their studies on the techniques' efficiency without assessing the patient's perception.
In addition to grafts harvested from the patient himself (autologous graft), bone graft can also be obtained from animals (xenograft), human cadavers (allograft) and synthetic materials (alloplastic graft). Patients may have ethical, religious or medical concerns about the origin of each bone graft, which could lead them to reject the use of certain types of bone graft in their surgery.
The aim of this multicenter study, which surveys patients from five university clinics in Portugal, Italy, Spain, France and Chile, is to analyze patients' opinions regarding the source of bone grafts.
A survey composed of 10 questions is submitted to the patients. They are asked about the degree of acceptance/rejection of each graft and their reasons for rejecting it.
In France, the survey will be presented to 100 patients having dental treatments in the "Centre de Soins Dentaires" of Montpellier from december of 2017 to june of 2018.
Eligibility criterias : adult (18 years of age or older), able to read and write in the local language, not under the influence of alcohol or drugs, had not previously undergone any surgery involving bone graft or bone augmentation, able to understand and follow the indications for the survey completion, willingness to participate in the study
Data obtained :
The survey is formed by two parts. The first part records the participant's demographic data, such as: gender, age, education level and religion: participants are asked, "Do you profess a religious faith?" (yes/no). In case of a positive answer, they are asked to which religion they adhere.
The second part of the survey consists of 10 questions regarding acceptance/rejection of the bone grafts. Patients are asked to mark only one answer, which best aligned with their opinion.
Questions are classified as follows:
Five closed-ended questions (with lists of possible answers) about the level of acceptance of each type of bone graft (acceptance, conditional acceptance or refusal).
Three open-ended questions (i.e., the patients' spontaneous answers were recorded).
Two mixed questions that aimed to identify the reasons for refusal (if applicable).
- Conditions
- Dental Treatment
- Being tested
- dental regenerative techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental regenerative techniquesOther
dental regenerative techniques
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of patients' opinions on the different types of biomaterials used in regenerative techniques.
Evaluation of patients' opinions on the different types of biomaterials used in regenerative techniques through a questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start15 Jan 2018
- Primary completion30 Sep 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental TreatmentStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona
- Responsible party
- Sponsor
- Investigators
- Marie ORDONNEAU, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538132
- Sponsor's protocol ID
- RECHMPL17_0456
- Acronym
- PEPABIO
- Status last verified
- Apr 2019
- First submitted
- 15 May 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Perception on Bone Biomaterials Used in Dentistry : a Multicentric Study
- ClinicalTrials.gov ID
- NCT03538132
- Acronym / sponsor ID
- PEPABIO / RECHMPL17_0456
- Conditions
- Dental Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University of Barcelona
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 25 May 2018 (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.
The goal of this study is to collect the patients' opinion about the different types of bone graft, to assess which are the most rejected by the patients and if the demographic variables (such as the gender or the age) and the level of education influence their decision.
Detailed description
Nowadays, many procedures may need regenerative techniques. Some studies have already assessed the patients' opinion regarding soft tissue grafts, some investigators have centered their studies on the techniques' efficiency without assessing the patient's perception.
In addition to grafts harvested from the patient himself (autologous graft), bone graft can also be obtained from animals (xenograft), human cadavers (allograft) and synthetic materials (alloplastic graft). Patients may have ethical, religious or medical concerns about the origin of each bone graft, which could lead them to reject the use of certain types of bone graft in their surgery.
The aim of this multicenter study, which surveys patients from five university clinics in Portugal, Italy, Spain, France and Chile, is to analyze patients' opinions regarding the source of bone grafts.
A survey composed of 10 questions is submitted to the patients. They are asked about the degree of acceptance/rejection of each graft and their reasons for rejecting it.
In France, the survey will be presented to 100 patients having dental treatments in the "Centre de Soins Dentaires" of Montpellier from december of 2017 to june of 2018.
Eligibility criterias : adult (18 years of age or older), able to read and write in the local language, not under the influence of alcohol or drugs, had not previously undergone any surgery involving bone graft or bone augmentation, able to understand and follow the indications for the survey completion, willingness to participate in the study
Data obtained :
The survey is formed by two parts. The first part records the participant's demographic data, such as: gender, age, education level and religion: participants are asked, "Do you profess a religious faith?" (yes/no). In case of a positive answer, they are asked to which religion they adhere.
The second part of the survey consists of 10 questions regarding acceptance/rejection of the bone grafts. Patients are asked to mark only one answer, which best aligned with their opinion.
Questions are classified as follows:
Five closed-ended questions (with lists of possible answers) about the level of acceptance of each type of bone graft (acceptance, conditional acceptance or refusal).
Three open-ended questions (i.e., the patients' spontaneous answers were recorded).
Two mixed questions that aimed to identify the reasons for refusal (if applicable).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that had been treated in the "Centre de soins, d'enseignements et de recherches dentaires de l'Université de Montpellier" between December of 2017 and June of 2018.
Key inclusion criteria (4 listed)
- Adult (18 years old or more)
- Able to read and write
- Not under the influence of alcohol or drugs
- Had not previously undergone any surgery involving bone graft or bone augmentation.
Key exclusion criteria (1 listed)
- Any patient who doesn't fullfill the inclusion criterias.
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 regenerative techniquesdental regenerative techniques | Other | – |
Primary outcome
Evaluation of patients' opinions on the different types of biomaterials used in regenerative techniques.
Time frame: 1 day
Evaluation of patients' opinions on the different types of biomaterials used in regenerative techniques through a questionnaire
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 18 Apr 2019.
- Individual participant dataSharing planned: Undecided. NC
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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.
Marie ORDONNEAU principal investigator
University Hospital, Montpellier
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 Treatment, run by University Hospital, Montpellier at 1 site in France.
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 4 inclusion and 1 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 18 Apr 2019. 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 France. 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?
Evaluation of patients' opinions on the different types of biomaterials used in regenerative techniques. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2019.