Trial record 3 of 274049 for:    ALL

Patients' Perception on Bone Grafts (PEPABIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03538132
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
University of Barcelona
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.

Condition or disease Intervention/treatment
Dental Treatment Other: dental regenerative techniques

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 Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Intervention Details:
    Other: dental regenerative techniques
    dental regenerative techniques

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Inclusion criteria:

  • 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.

Exclusion criteria:

- Any patient who doesn't fullfill the inclusion criterias.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03538132

Contact: Marie ORDONNEAU, Pregrade 4th year 678300007 ext 33

Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: Marie ORDENNEAU    678300007 ext 33   
Sponsors and Collaborators
University Hospital, Montpellier
University of Barcelona
Principal Investigator: Marie ORDONNEAU University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier Identifier: NCT03538132     History of Changes
Other Study ID Numbers: RECHMPL17_0456
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No