| CTRI Number |
CTRI/2024/07/070923 [Registered on: 19/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of various methods to record jaw relation |
|
Scientific Title of Study
|
Comparative evaluation of mandibular retrusion with various tentative and definitive methods of recording centric relation: an 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 Preksha Shah |
| Designation |
Post Graduate student |
| Affiliation |
Narsinhbhai Patel Dental College And Hospital , Visnagar |
| Address |
Department no. 3
Department of Prosthodontics and Crown & Bridge,
Narsinhbhai Patel Dental College and Hospital, Visnagar , Gujarat
Mahesana
GUJARAT
384315
India |
| Phone |
08401223776 |
| Fax |
|
| Email |
preksha1474@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kavan Patel |
| Designation |
Professor |
| Affiliation |
Narsinhbhai Patel Dental College And Hospital , Visnagar |
| Address |
Department no. 3
Department of Prosthodontics and Crown and Bridge
Narsinhbhai Patel Dental College And Hospital, Visnagar
Mahesana
GUJARAT
384315
India |
| Phone |
09099292954 |
| Fax |
|
| Email |
k1dentist4u@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preksha Shah |
| Designation |
Post Graduate student |
| Affiliation |
Narsinhbhai Patel Dental College And Hospital , Visnagar |
| Address |
Department no. 3
Department of Prosthodontics and Crown & Bridge
Narsinbhai Pate; Dental College and Hospital, Visnagar.
Mahesana
GUJARAT
384315
India |
| Phone |
08401223776 |
| Fax |
|
| Email |
preksha1474@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narsinhbhai Patel Dental College And Hospital , Visnagar 384315
District: Mahesana
Gujarat , India
|
|
|
Primary Sponsor
|
| Name |
Dr Preksha Shah |
| Address |
Narsinhbhai Patel Dental College And Hospital , Visnagar 384315
District: Mahesana
Gujarat , India
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Kavan Patel |
Sakalchand Patel University
near kada chokdi, Visnagar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Preksha Shah |
Narsinbhai Patel Dental College And Hospital |
Department no.3
Department of Prosthodontics and Crown & Bridge
Narsinhbhai Patel Dental College And Hospital , Visnagar 384315
District: Mahesana
Gujarat , India
Mahesana
GUJARAT |
08401223776
preksha1474@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narsinhbhai Patel Dental College And Hospital Institutional Ethics Committee |
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 |
Definitive method for recording jaw relation |
gothic arch tracing will be used
with extraoral tracers |
| Intervention |
Tentative methods of comparing various methods to retrude the jaw |
various methods to retrude the jaw will be intervened to retrude the jaw to record the jaw relation .
1) Swallowing
2) TENS
3) Ask the patient to touch the tongue on the palate
4) Ask the patient to protrude the maxilla
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. less than 3 years of edentulism
2. class 1 or class 2 jaw relation
3. poor neuromuscular control |
|
| ExclusionCriteria |
| Details |
1.Temporomandibular disorders
2.Resorbed ridges
3.Poor general health
4. class 3 jaw relationship
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the best physiologic method for mandible retrusion for centric relation. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the better method for retrusion of mandible in patients with poor neuromuscular coordination. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
30/08/2024 |
| 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
|
15 patients will be selected based on the inclusion and exclusion criteria to perform the tentative and definitive methods of retruding the mandible . each patient’s jaw will be retudred using different methods to record jaw relation . Each of the tentative method will be compared with the definitive method and the best method to retrude the mandible will be suggested
|