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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
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patient Satisfaction focused on measuring Occlusal vertical dimension, edentulous patients,

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
March 23, 2021
Last Updated
December 9, 2021
Sponsor
Dow University of Health Sciences
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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.
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Correlation of Length of Index Finger to Vertical Dimensions of Occlusion for Edentulous Patients

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