A trial to evaluate the effect of obturator on oral health related quality of life made using traditional and digital technique.
Phase 3
- Conditions
- Health Condition 1: C058- Malignant neoplasm of overlappingsites of palateHealth Condition 2: K088- Other specified disorders of teethand supporting structures
- Registration Number
- CTRI/2024/03/063962
- Lead Sponsor
- Dr Bhavita Wadhwa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Oral health related quality of life using OHIP 14Timepoint: Baseline, 4 weeks, 8 weeks
- Secondary Outcome Measures
Name Time Method Patient satisfactionTimepoint: first in 4 weeks followed by 2 weeks wash out period followed by follow up in 4 weeks