| CTRI Number |
CTRI/2025/10/096362 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EVALUATION and COMPARISON OF NUTRITIONAL STATUS, ORAL HEALTH-RELATED QUALITY OF LIFE, AND ORAL HYGIENE CONDITION IN PATIENTS BEFORE AND AFTER OBTURATOR PROSTHESIS REHABILITATION FOLLOWING MAXILLECTOMY: A CLINICAL STUDY |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF NUTRITIONAL STATUS, ORAL HEALTH-RELATED QUALITY OF LIFE, AND ORAL HYGIENE CONDITION IN PATIENTS BEFORE AND AFTER OBTURATOR PROSTHESIS REHABILITATION FOLLOWING MAXILLECTOMY: A CLINICAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Chhetri |
| Designation |
Post Graduate Student |
| Affiliation |
SCB Dental college and Hospital |
| Address |
Department of Prosthodontics and Crown and Bridge, SCB Dental College and Hospital
Cuttack
ORISSA
753007
India |
| Phone |
7005188340 |
| Fax |
|
| Email |
pc30855@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Angurbala Dhal |
| Designation |
Associate Professor |
| Affiliation |
SCB Dental College and Hospital |
| Address |
Department of Prosthodontics and Crown and Bridge, SCB Dental College and Hospital
Scb Dental college and Hospital
Cuttack
ORISSA
753007
India |
| Phone |
9437303876 |
| Fax |
|
| Email |
drangurbaladhal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Angurbala Dhal |
| Designation |
Associate Professor |
| Affiliation |
SCB Dental College and Hospital |
| Address |
Department of Prosthodontics and Crown and Bridge, SCB Dental College and Hospital
Scb Dental college and Hospital
Cuttack
ORISSA
753007
India |
| Phone |
9437303876 |
| Fax |
|
| Email |
drangurbaladhal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SCB Dental college and hospital |
| Address |
S.C.B DENTAL COLLEGE AND HOSPITAL, CUTTACK, ODISHA, 753007, INDIA |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Chhetri |
SCB DENTAL COLLEGE AND HOSPITAL |
Department of Prosthodontics and Crown and Bridge, SCB Dental College and Hospital
Ladies Hostel, SCB Medical college and Hospital
Cuttack
ORISSA |
07005188340
pc30855@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, SCB DENTAL COLLEGE AND HOSPITAL, CUTTACK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D498||Neoplasm of unspecified behavior of other specified sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Obturator Prosthesis Rehabilitation |
The patients who have undergone maxillectomy and present with a maxillary defect will be rehabilitated with an obturator prosthesis, which is a maxillofacial prosthesis used to close a congenital or acquired tissue opening, primarily of the hard palate and/or contiguous alveolar/soft tissue structures.
The prosthesis can be used by patients for lifetime.
followed up until 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with maxillary defect due to maxillectomy for oral cancer, requiring an obturator prosthesis irrespective of gender.
2. Patients aged 18 years and above
3.Patient with maxillary defect classified under Aramany classification class I-VI and/or soft palate defect
|
|
| ExclusionCriteria |
| Details |
1.Patient requiring surgical or delayed surgical obturator not evaluated for the study
2.Completely edentulous patient.
3.Patient with an associated systemic disease like cardiovascular disease, or chronic disease related to liver, kidney, or GIT.
4.Patient with restrictive mouth opening (15 mm or less).
5.Physical & neurological disability that will interfere with the study.
6.Patient showing evidence of local recurrence.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nutritional status, oral health related quality of life and oral hygiene conditions in patients before and after obturator prosthesis rehabilitation following maxillectomy. |
Baseline, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A total of 30 patients (sample size selected according to the central limit theorem), presenting with a maxillary defect following maxillectomy due to surgery for maxillary cancer, will be selected for the study based on the above-mentioned criteria and provided with an obturator prosthesis as required. All participants will fill out written informed consent forms before recruitment. They will be informed about the study procedure and associated discomfort in the written information sheet. A case history shall be recorded & clinical examination of the patient shall be done. Pre-prosthetic treatment evaluation 1. Nutritional status of the patient will be evaluated using three nutritional assessment tool a) patient generated- subjective global assessment(PG-SGA) b) nutritional risk index (NRI) or Buzby index c) Malnutrition Universal Screening Tool (MUST). 2. Oral hygiene-related quality of life will be evaluated using the oral health impact profile (OHIP-14). 3. Oral hygiene condition will be calculated using: O’Leary’s Plaque control record
Procedure for fabrication of an obturator The primary impression of the patient will be made with an irreversible hydrocolloid (alginate). Border moulding using green stick impression compound (DPI, Bombay Burmah Trading Corp Ltd, Mumbai, India) and secondary impression will then be made if necessary. Master cast will be poured with type III gypsum, and maxillomandibular relation recording will be made, if necessary, upon which the obturator will be fabricated using Poly methyl methacrylate (PMMA) resin (DPI, Bombay Burmah Trading Corp Ltd, Mumbai, India) and stainless-steel wire will be used for the fabrication of clasps. The prosthesis will then be delivered to the patient after proper occlusal adjustment if necessary and proper oral hygiene instructions will be given. Follow-up evaluation will be made 1 month and 3 months after the treatment. Post-prosthetic treatment evaluation 1. Oral hygiene-related quality of life will be evaluated using the oral health impact profile (OHIP-14) 1 month after the treatment 2. Oral hygiene condition will be calculated using O’Leary’s Plaque control record of the remaining teeth 1 month after the treatment 3. Nutritional status of the patient will be evaluate 3 months after the treatment |