A trial to evaluate the effect of obturator on oral health related quality of life made using traditional and digital technique.

A cross-over randomized control trial to evaluate the influence of obturator on oral health related quality of life made using conventional and digital method. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063962

Enrollment

100

Registered

2024-03-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: C058- Malignant neoplasm of overlappingsites of palate Health Condition 2: K088- Other specified disorders of teethand supporting structures

Interventions

Intervention1: Digitally Fabricated Obturator: This digitally fabricated obturator is given for 1 months followed by 2 weeks wash out period with the interm obturator. Control Intervention1: Conventio

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Patients both males and females with age range of 18-80 years old. 2. Well healed maxillary defects resulting from the surgical resection of benign and malignant tumours of maxilla, infectious diseases, osteomyelitis, and trauma. 3. Patients with untreated cleft palate. 4. Patients who provide informed consent for the study

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Maxillary defects due to recurrent malignancy 2. Completely edentulous patients 3. Patients with bilateral maxillectomy 4. Syndromic patients 5. Patients who underwent radiotherapy less than 6 months ago. 6. Pregnant patients at the time of recruitment 7. Patients not consenting for the treatment and follow-up schedule

Design outcomes

Primary

Measure	Time frame
Oral health related quality of life using OHIP 14Timepoint: Baseline, 4 weeks, 8 weeks	—

Secondary

Measure	Time frame
Patient satisfactionTimepoint: first in 4 weeks followed by 2 weeks wash out period followed by follow up in 4 weeks	—

Countries

India

Contacts

Public ContactDr Bhavita wadhwa

Post Graduate Institute of Medical Education and Research Chandigarh

drbhavitamds@gmail.com8283827291

Outcome results

None listed

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