Correlation of Length of Index Finger to Vertical Dimensions of Occlusion for Edentulous Patients
Primary Purpose
Patient Satisfaction, Dental Prosthesis, Edentulous Jaw
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Finger lengths
Conventional method
Sponsored by
About this trial
This is an interventional treatment trial for Patient Satisfaction focused on measuring Occlusal vertical dimension, edentulous patients,
Eligibility Criteria
Inclusion Criteria:
- Completely edentulous patients
- Patients willing to participate in the study
- Male patients without a beard
Exclusion Criteria:
- Partially dentate patients
- Patients having any maxillofacial or myofascial disorders
- Any history of orthognathic or orthodontic surgery
- Deformities or disfigurement of fingers
- Patients with neurological problems in the head and neck
- Any bony defects or visible sharp spicules
- Nose or chin deformity
- TMJ disorders (intracapsular/extracapsular)
- Heavy bulky chin area (double chin)
Sites / Locations
- Dow University of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Finger Lengths
Conventional method
Arm Description
Vernier caliper was used to determine the length of Index Finger to record Vertical Dimensions of Occlusion
Willis gauge was used to determine the Length from Base of the nose to Base of the chin to record Vertical Dimensions of Occlusion
Outcomes
Primary Outcome Measures
Satisfaction with Complete Dentures
Satisfaction with Complete Dentures after assessment of occlusal vertical dimension with Length of Index Finger
Secondary Outcome Measures
Full Information
NCT ID
NCT05153213
First Posted
March 23, 2021
Last Updated
December 9, 2021
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05153213
Brief Title
Correlation of Length of Index Finger to Vertical Dimensions of Occlusion for Edentulous Patients
Official Title
Correlation of Length of Index Finger to Vertical Dimensions of Occlusion for Edentulous Patients and Assessment of Patient Satisfaction - A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a randomized clinical trial comparing the conventional method of recording occlusal vertical dimension using Willis gauge from the base of the nose to the base of the chin with the other method using vernier caliper for the length of the index finger to access the satisfaction level of edentulous patients acquiring complete dentures.
Detailed Description
This study was to apply the anthropometric methods to correlate the length of fingers to occlusal vertical dimensions and also by using the Willis Method to assess the occlusal vertical dimension for edentulous patients and assess satisfaction by comparing both the methods for patients who are in the process of acquiring complete dentures. Furthermore, conventional methods are applied most commonly for the recording of occlusal vertical dimensions. This study also bridged the knowledge gap among clinicians to adapt to a different methodology for recording the VDO using the anthropometric measurement of fingers which would improve denture satisfaction. Therefore, a total of 71 patients were selected for this study, having lost their OVD due to the complete absence of teeth and having no history of maxillofacial or orthognathic surgery, nor any skeletal deformities or disfigurement of fingers. The measurements were made at the appointment for jaw relations records in which the length of the fingers was measured with a digital Vernier caliper and also the conventional methods were applied for recording the occluding vertical dimensions which included recording the distance from the base of the nose septum (Subnasion - Sn) to the base of the chin (Menton - Me) (Sn-Me). The length of the index finger (2D) was recorded and a correlation was found between Sn-Me and finger length.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Satisfaction, Dental Prosthesis, Edentulous Jaw
Keywords
Occlusal vertical dimension, edentulous patients,
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Finger Lengths
Arm Type
Experimental
Arm Description
Vernier caliper was used to determine the length of Index Finger to record Vertical Dimensions of Occlusion
Arm Title
Conventional method
Arm Type
Active Comparator
Arm Description
Willis gauge was used to determine the Length from Base of the nose to Base of the chin to record Vertical Dimensions of Occlusion
Intervention Type
Procedure
Intervention Name(s)
Finger lengths
Intervention Description
Vernier caliper was used to measure finger length
Intervention Type
Procedure
Intervention Name(s)
Conventional method
Intervention Description
Gillis gauge was used to measure occlusal vertical dimension
Primary Outcome Measure Information:
Title
Satisfaction with Complete Dentures
Description
Satisfaction with Complete Dentures after assessment of occlusal vertical dimension with Length of Index Finger
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Completely edentulous patients
Patients willing to participate in the study
Male patients without a beard
Exclusion Criteria:
Partially dentate patients
Patients having any maxillofacial or myofascial disorders
Any history of orthognathic or orthodontic surgery
Deformities or disfigurement of fingers
Patients with neurological problems in the head and neck
Any bony defects or visible sharp spicules
Nose or chin deformity
TMJ disorders (intracapsular/extracapsular)
Heavy bulky chin area (double chin)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shujah A Khan, BDS
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dow University of Health Sciences
City
Karachi
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28600914
Citation
Alhajj MN, Khalifa N, Abduo J, Amran AG, Ismail IA. Determination of occlusal vertical dimension for complete dentures patients: an updated review. J Oral Rehabil. 2017 Nov;44(11):896-907. doi: 10.1111/joor.12522. Epub 2017 Jun 10.
Results Reference
background
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Correlation of Length of Index Finger to Vertical Dimensions of Occlusion for Edentulous Patients
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