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Comparing patient comfort and satisfaction with two types of complete dentures in people without teeth: A randomized crossover clinical trial

Assessment of long-term patient satisfaction of complete dentures fabricated using simplified and conventional complete dentures on oral health impact profile for edentulous patients (OHIP-EDENT): A randomized double-blinded crossover clinical trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100408
Enrollment
50
Registered
2026-01-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: K081- Complete loss of teeth

Interventions

Intervention1: Simplified complete denture: Fabrication of complete denture using simplified technique and inserted to patient for 3 months Control Intervention1: Conventional complete denture: Fabric

Sponsors

Department of Prosthodontics ESIC Dental College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Completely edentulous maxillary and mandibular arches Previous complete denture wearers Severly resorbed mandibular ridge Possessing an adequate understanding of written and spoken Hindi/Kannada/English. Able to understand and respond to the questionnaire used in the study

Exclusion criteria

Exclusion criteria: Acute/chronic symptoms of temporomandibular disorders Uncontrolled systemic diseases Any oral pathology requiring intervention Psychological conditions that could influence the patient s reaction to the treatment Flabby residual ridges Smokers and tobacco users Patients wanting dental implants

Design outcomes

Secondary

MeasureTime frame
Patient satisfaction assessed using a 100-mm horizontal Visual Analogue Scale (VAS) at the end of each study period. Subjective assessment of denture performance, including: Comfort Stability Chewing efficiency Overall satisfactionTimepoint: 3 months: End of Period 1 6 months: End of Period 2 (after crossover)

Primary

MeasureTime frame
Oral health related quality of life (OHRQoL) assessed using the Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT) questionnaire at the end of each study period (3 months after denture insertion).Timepoint: 3 months: End of Period 1 6 months: End of Period 2 (after crossover)

Countries

India

Contacts

Public ContactDivakar S

ESIC Dental College and Hospital

divakarsanthanam17@gmail.com7418296274

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026