A multicenter randomized controlled trial for evaluating timing and clinical outcomes of the technique in making complete dentures

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10987118

Enrollment

Registered

2015-10-22

Start date

2011-02-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulism Oral Health

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026