| CTRI Number |
CTRI/2024/04/066162 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Importance of Facial and Hand Measurements for recording Vertical height of the face for patients having no teeth. |
|
Scientific Title of Study
|
Assessment of reliability of anthropometric measurements accepted in dentate population to establish vertical dimension of occlusion in completely edentulous patients: A Cross sectional 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 Niraja Jaiswal |
| Designation |
Associate professor |
| Affiliation |
Government Dental College and Hospital,Mumbai |
| Address |
Government Dental College and Hospital, St. George hospital campus, PDMellow road, near GPO, Fort, Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
02222620668 |
| Fax |
|
| Email |
drnirajajaiswal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Pande |
| Designation |
Professor |
| Affiliation |
VSPM Dental College and Research Centre, Nagpur |
| Address |
VSPM Dental College and Research Centre, Nagpur
Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440 019
India |
| Phone |
07104665000 |
| Fax |
07104665011 |
| Email |
neelampande112@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niraja Jaiswal |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital,Mumbai |
| Address |
Government Dental College and Hospital, St. George hospital campus, PDMellow road, near GPO, Fort, Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
02222620668 |
| Fax |
|
| Email |
drnirajajaiswal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Niraja Jaiswal |
| Address |
Government Dental College and Hospital, St. George hospital campus, PDMellow road, near GPO, Fort, Mumbai |
| Type of Sponsor |
Other [self] |
|
|
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 Niraja Jaiswal |
Government Dental College and Hospital , Mumbai |
room no: 227,2nd floor
Department of
Prosthodontics.
Mumbai
MAHARASHTRA |
9769644860
drnirajajaiswal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital,Mumbai |
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 |
dentulous patients |
facial and hand measurements |
| Intervention |
edentulous patient |
facial and hand measurements |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criterion for dentulous patient
1. 30- 50 years
2.full complement of permanent dentition few or few teeth missing
3.class I jaw relation
Inclusion Criterion for edentulous patient
1.40- 65 years |
|
| ExclusionCriteria |
| Details |
Exclusion Criterion for dentulous patient
1. severe attrition
2. multiple missing teeth
3. supra eruption and physiologic migration of
teeth
4. deep bite or open bite
5. temporomandibular joint disorder
6. Extensive restorations
7. patient with hand and facial deformity
8. history of oral and maxillofacial trauma
9. history of orthodontic treatment
Exclusion Criterion for Edentulous Patient
1.temporomandibular joint disorder
2.facial and hand deformity
3.history of oral and maxillofacial trauma
4.poor neuromuscular coordination
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anthropometric measurements are reliable for measuring vertical dimension of occlusion. |
Anthropometric measurements are reliable for measuring vertical dimension of occlusion at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
10/05/2024 |
| 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="4"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drnirajajaiswal@gmail.com].
- For how long will this data be available start date provided 18-04-2024 and end date provided 05-06-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Establishing the correct vertical dimension of occlusion is of paramount
importance in rehabilitation of completely edentulous patients both for optimum
function and aesthetics. The loss of vertical dimension plays a havoc on the stomatognathic
system in the form of degenerative changes in the tissues, bone as well as the
temporomandibular joint due to the disharmony in the masticatory system. Diverse techniques have been suggested to determine the correct vertical
dimension of occlusion, like the use of physiologic rest position, phonetics method, tactile sense, aesthetic
appearance, swallowing threshold, cephalometric
radiograph, pre-extraction record, Boos bimetre method, electromyographic methods, anthropological
measurement and many more. Despite the popularity of using rest position as a starting point of
determining VDO, it has been debated by few other authors. The
determination of VDO in edentulous patients has always been relied on the
measurement of VDR which shows subjective variability. Hence some fixed
anthropological measurements can be utilized to determine the VDO to minimize
subjective variability. There can be some variation between craniofacial distances and the VDO
due to gender and racial differences. To some extent the variations in all the
measurements found may be due to the differences in measuring techniques,
ethnicities of the population and sample size studied. However, if an
anthropometric correlation is found between the VDO of dentulous patients in
local population which is static and easily accessible to the clinician, the
time taken for establishing VDO in edentulous patients could be significantly
reduced. As these are objective measurements rather than subjective criteria,
the guesswork in VDO will be eliminated. Considering the paucity of data on this topic, our study aims to check
the reliability of such correlation of anthropological measurements in
establishing vertical dimension of occlusion in edentulous local population. Such
correlation between anthropometric measurements and VDO would give clinicians
an evidence-based approach to establish VDO during rehabilitation of edentulous
patients. This
cross-sectional study will be conducted in Department of Prosthodontics and
Crown & Bridge. The study population will be selected from the pool of dentulous
and edentulous patients reporting to the department of Oral Medicine, Diagnosis
and Radiology and department of Prosthodontics and Crown and Bridge fulfilling
inclusion and exclusion criteria. Total
of 500 patient selected for this study, 250 dentate and 250 edentulous patients
depending on inclusion and exclusion criterion. Further this study population
is divided into four groups. Group 1 (G1) –125 dentate male, Group 2 (G2) -
dentate female, Group 3 (G3) edentulous male and Group 4 (G4) edentulous
female. All the facial and finger measurements will be recorded clinically using
a digital vernier calliper with an accuracy of 0.01 mm.
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