Condition category
Oral Health
Date applied
06/10/2015
Date assigned
22/10/2015
Last edited
21/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paola Ceruti

ORCID ID

http://orcid.org/0000-0001-7240-8126

Contact details

v. Nizza
230
Turin
10126
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Simplified Edentulous Treatment: a multicenter randomized controlled trial in edentulous patients for evaluating timing and clinical outcomes of the technique

Acronym

SET

Study hypothesis

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

Ethics Committee of the Province of Ferrara, 25/11/2010, protocol number 9/2010

Study design

Interventional multicentre parallel single-blind controlled randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/09/2011

Overall trial end date

01/07/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Edentulous patients requiring rehabilitation by means of maxillary and mandibular complete dentures

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

64

Participant 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

Recruitment start date

01/02/2011

Recruitment end date

31/07/2011

Locations

Countries of recruitment

Italy

Trial participating centre

University of Turin
Turin
10124
Italy

Trial participating centre

University of Ferrara
44121
Italy

Trial participating centre

University of Siena
Siena
53100
Italy

Sponsor information

Organisation

Università degli Studi di Torino (Italy)

Sponsor details

v. Nizza
230
Torino
10126
Italy

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Università degli Studi di Torino

Alternative name(s)

University of Turin, UNITO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Italy

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes