| CTRI Number |
CTRI/2026/04/107423 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
02/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Impact of conventional versus functional palatal contours of maxillary complete denture on speech in completely edentulous patients |
|
Scientific Title of Study
|
Impact of conventional versus functional palatal contours of maxillary complete denture on speech in completely edentulous patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
H HARSHITHA |
| Designation |
JR resident |
| Affiliation |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH |
| Address |
No205, sector 15 A, Chandigarh, 160015.
No 107,Unit of Prosthodontics,Oral Health Sciences Centre,POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH,160012.
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9944511180 |
| Fax |
|
| Email |
harshithakoumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BHAVITA WADHWA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH,160012. |
| Address |
No 107,Unit of prosthodontics, Oral Health Sciences Centre,POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH,160012.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8283827291 |
| Fax |
|
| Email |
drbhavitamds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
H HARSHITHA |
| Designation |
JR resident |
| Affiliation |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH,160012. |
| Address |
No205, sector 15 A, Chandigarh, 160015.
no 107, Unit Of Prosthodontics,Oral Health Sciences Centre,POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH,160012.
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9944511180 |
| Fax |
|
| Email |
harshithakoumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH,160012. |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
OHSC,Post Graduate Institute of Medical Education and Research, Chandigarh-160012 |
| 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 |
| Harshitha H |
Post Graduate Institute of Medical Education and Research. |
no 107,Unit of Prosthdontics Oral Health Sciences Centre, Post Graduate Institute of Medical Education and Research Chandigarh 160012
Chandigarh
CHANDIGARH |
994 451 1180
harshithakoumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Reseach,Chandigarg ,Institutional Ethics Committee( Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
completely missing teeth people |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
complete dentures with functional palatal contours. |
one complete dentures with functional palatal contours in the palatal area, the denture will be given for 1 month |
| Comparator Agent |
conventional complete dentures |
one normal complete dentures with normal flat palate will be given for 1 month |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients seeking new complete dentures for the first time.
2. Patients who had been completely edentulous for at least 3 months.
3. Age: 45-65 years.
4. Patients who comes under class I and class II of ACP classification of completely edentulous patients.
5. Patients who can read Hindi or Punjabi.
6. Patients who will sign consent form. |
|
| ExclusionCriteria |
| Details |
1. Patients with any congenital or acquired maxillofacial defects.
2. Head and neck cancer patients with history of surgical resection or radiotherapy or planned for the same.
3. Patients with severe underlying medical conditions, neuromuscular dysfunction, auditory problems, mental conditions, oral pathology or xerosthomia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acoustic analysis |
pretreatment and 1 month follow up and crossover again after 1 month later |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| speech intelligibility |
pretreatment and 1 month follow up and crossover again after 1 month later |
| articulation proficiency |
pretreatment and 1 month follow up and crossover again after 1 month later |
| nasalance |
pretreatment and 1 month follow up and crossover again after 1 month later |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
14/04/2026 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [harshithakoumar@gmail.com].
- For how long will this data be available start date provided 20-02-2026 and end date provided 20-02-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized crossover clinical trail, comparing complete dentures with functional palatal contours and conventional complete dentures with flat palate for completely edentulous patients with sample size of total 28 people with no teeth who needs new dentures for the first time, the study will be conducted in OHSC, PGIMER, Chandigarh, the primary outcome measures the acoustic analysis before the treatment and the after 1 month of delivering interventional denture and then crossover with wash out period of 1 week and then after 1 month of comparator denture so totally primary outcome is checked at 3 period of time, secondary outcomes are intelligibilty test, articulation proficiency and nasalance at the same 3 period of time. |