A multicenter randomized controlled trial for evaluating timing and clinical outcomes of the technique in making complete dentures
| ISRCTN | ISRCTN10987118 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10987118 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/10/2015
- Registration date
- 22/10/2015
- Last edited
- 21/10/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Denture treatment can be a very complex and long-lasting process, involving many steps. Many simplified procedures have been introduced to shorten the process and to improve comfort for patients. The aim of this study was to compare two different techniques: a traditional, long-lasting technique that involves 6 clinical sessions, and a new, simplified and shorter technique that involves 2 to 3 sessions.
Who can participate?
Patients who need complete dentures (i.e., a full set of false teeth).
What does the study involve?
Participants are randomly allocated to receive either traditional treatment or the new simplified shorter treatment. For each patient we record the time spent during clinical procedures, the time spent during laboratory procedures, and the number of clinical sessions. The clinical quality of the dentures and the patients' satisfaction are assessed using questionnaires.
What are the possible benefits and risks of participating?
Patients may benefit from receiving a shorter treatment but will have to spend some more time for the study procedures and questionnaires. There are no risks related to the treatment.
Where is the study run from?
Universities of Torino, Ferrara and Siena (Italy).
When is the study starting and how long is it expected to run for?
September 2011 to July 2013.
Who is funding the study?
Università degli Studi di Torino (Italy).
Who is the main contact?
Dr Paola Ceruti
Contact information
Scientific
v. Nizza, 230
Turin
10126
Italy
 ORCID ID |
0000-0001-7240-8126 |
|---|
Study information
| Study design | Interventional multicentre parallel single-blind controlled randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Simplified Edentulous Treatment: a multicenter randomized controlled trial in edentulous patients for evaluating timing and clinical outcomes of the technique |
| Study acronym | SET |
| Study objectives | The hypothesis was that there are between-group differences in clinical and laboratory timing, number of clinical sessions and number of exchanges, and no between-group differences in patient satisfaction and denture quality, among the two treatment groups. |
| Ethics approval(s) | Ethics Committee of the Province of Ferrara, 25/11/2010, protocol number 9/2010 |
| Health condition(s) or problem(s) studied | Edentulism |
| Intervention | Patients were randomly assigned to two groups: 1. The traditional treatment group (control group) receive traditional rehabilitation 2. The SET group (study group) receive the innovative, simplified rehabilitation |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Time (minutes) spent during clinical procedures 2. Time (minutes) spent during laboratory procedures 3. Number of clinical sessions 4. Number of laboratory returns |
| Secondary outcome measures | 1. At delivery, clinical quality of the dentures was assessed by means of a questionnaire filled by a blinded expert 2. Six months after the delivery, patient satisfaction was assessed by means of a specific questionnaire 3. Patients were also asked to express a judgment on the treatment modalities |
| Overall study start date | 01/09/2011 |
| Completion date | 01/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 64 |
| Key inclusion criteria | Edentulous patients requiring rehabilitation by means of maxillary and mandibular complete dentures |
| Key exclusion criteria | Presence of temporo-mandibular disorders, xerostomia, orofacial motor disorders, systemic diseases with oral manifestations, psychological or psychiatric conditions that could influence their response to treatment |
| Date of first enrolment | 01/02/2011 |
| Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- Italy
Study participating centres
10124
Italy
Italy
53100
Italy
Sponsor information
University/education
v. Nizza, 230
Torino
10126
Italy
"ROR" |
https://ror.org/048tbm396 |
|---|
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Turin in Italy, University of Turin, Italy, Università di Torino, 都灵大学, University of Turin, UNITO
- Location
- Italy
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
