Patients' Perception on Bone Grafts (PEPABIO)
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|ClinicalTrials.gov Identifier: NCT03538132|
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
|Condition or disease||Intervention/treatment|
|Dental Treatment||Other: dental regenerative techniques|
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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Patients' Perception on Bone Biomaterials Used in Dentistry : a Multicentric Study|
|Actual Study Start Date :||January 15, 2018|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||December 30, 2018|
Other: dental regenerative techniques
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538132
|Contact: Marie ORDONNEAU, Pregrade 4th year||678300007 ext email@example.com|
|Montpellier, France, 34295|
|Contact: Marie ORDENNEAU 678300007 ext 33 firstname.lastname@example.org|
|Principal Investigator:||Marie ORDONNEAU||University Hospital, Montpellier|