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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05153213
Other study ID # SAKhanDowUHS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date March 1, 2020

Study information

Verified date December 2021
Source Dow University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date March 1, 2020
Est. primary completion date July 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 80 Years
Eligibility 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)

Study Design


Intervention

Procedure:
Finger lengths
Vernier caliper was used to measure finger length
Conventional method
Gillis gauge was used to measure occlusal vertical dimension

Locations

Country Name City State
Pakistan Dow University of Health Sciences Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Satisfaction with Complete Dentures Satisfaction with Complete Dentures after assessment of occlusal vertical dimension with Length of Index Finger 6 Months
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