| CTRI Number |
CTRI/2025/05/087874 [Registered on: 29/05/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study is to evaluate the effect of occlusal adjustment of complete dentures based on virtual and physical occlusal contact points on patient comfort and post insertion visits of complete denture patients |
|
Scientific Title of Study
|
Evaluation of effect of occlusal equilibration of complete dentures based on virtual and physical occlusal contact points on patient comfort and post operative visits: a comparative in vivo 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. Soumya Bhasin |
| Designation |
Student |
| Affiliation |
HSJ Institute of Dental Sciences and Research |
| Address |
Room no 126, Department of Prosthodontics, Dr. Harvansh Singh Judge Institute of Dental Science, Panjab University, Sector 25 Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
8920141765 |
| Fax |
|
| Email |
soumyabhasin7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shefali Singla |
| Designation |
Head of Department |
| Affiliation |
HSJ Institute of Dental Sciences |
| Address |
Room no 126, Department of Prosthodontics, Dr. Harvansh Singh Judge Institute of Dental Sciences, Panjab University, Sector 25 Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9417194185 |
| Fax |
|
| Email |
shefali_singla@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Soumya Bhasin |
| Designation |
Student |
| Affiliation |
Harvansh Singh Judge Institute of Dental Sciences |
| Address |
Room 126, Department of Prosthodontics, Dr. Harvansh Singh Judge Institute of Dental Sciences, Panjab University, Sector 25, Chandigarh.
Chandigarh
CHANDIGARH
160014
India |
| Phone |
8920141765 |
| Fax |
|
| Email |
soumyabhasin7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics, Dr. Harvansh Singh Judge Institute of Dental Science, Panjab University |
| NIL |
|
|
Primary Sponsor
|
| Name |
Panjab University |
| Address |
Panjab University, Sector 25, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Soumya Bhasin |
Dr. Harvansh Singh Judge Institute of Dental Science |
Room no 126, Department of Prosthodontics, Panjab University, Sector 25, Chandigarh 160014
Chandigarh
CHANDIGARH |
8920141765
soumyabhasin7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Panjab University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physical contacts |
Occlusal Equilibration of Complete Dentures using Physical Contact Points obtained using Articulating paper. The duration of intervention is 1 day (day of denture insertion) with a follow up period of 2 months. |
| Intervention |
Virtual contacts |
Occlusal Equilibration of Complete Dentures using Virtual Contact Points obtained using Intraoral Scanner. The duration of intervention is 1 day (day of denture insertion) with a follow up period of 2 months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Completely edentulous subjects requiring upper and lower complete dentures
Subjects free from systemic diseases
Subjects who provided informed consent
|
|
| ExclusionCriteria |
| Details |
Subjects with poor residual ridge anatomy or abnormal jaw relations
Subjects requiring complete denture in a single arch.
Subjects with temporomandibular joint disorder and habit of unilateral mastication.
Subjects with neuromuscular disorders.
Subjects likely to shift out of the area within the 1 year duration of the study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To perform occlusal equilibration of complete dentures based on physical contacts obtained by means of articulating paper and evaluate its effect on patient comfort and post operative visits. (Group 1)
To perform occlusal equilibration of complete dentures based on virtual contacts obtained by an intraoral scanner and evaluating its effect on patient comfort and post operative visits. (Group 2)
|
48 hours, 1 week and then as necessary |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of occlusal equilibration based on virtually & physically determined occlusal contact on patient comfort & post operative visits |
48 hours, 1 week & then as necessary |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
30/06/2025 |
| 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 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 - NO
|
|
Brief Summary
|
Research has indicated that occlusal adjustment of
complete dentures using articulating paper in the patient’s mouth directly to
mark occlusal contact points, creates more false contacts. Low accuracy and reliability of visual inspection of physical contacts and false, unclear markings lead to unnecessary grinding
of the artificial teeth, decreasing the longevity of the dentures. The study has been planned to evaluate the effect of occlusal equilibration of complete dentures based on virtual contacts obtained using intraoral scanner and physical occlusal contact points obtained using articulating paper which is the conventional approach, on patient comfort and post operative visits. |