Patients' Perception on Bone Grafts (PEPABIO)

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.

Study Overview

• Status: Completed
• Conditions: Dental Treatment
• Intervention / 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
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: University of Barcelona
• Investigators: Principal Investigator: Marie ORDONNEAU, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 24, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: RECHMPL17_0456

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No