NCT05153213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2021

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

March 23, 2021

Last Update Submit

December 9, 2021

Conditions

Keywords

Occlusal vertical dimension, edentulous patients,

Outcome Measures

Primary Outcomes (1)

  • Satisfaction with Complete Dentures

    Satisfaction with Complete Dentures after assessment of occlusal vertical dimension with Length of Index Finger

    6 Months

Study Arms (2)

Finger Lengths

EXPERIMENTAL

Vernier caliper was used to determine the length of Index Finger to record Vertical Dimensions of Occlusion

Procedure: Finger lengths

Conventional method

ACTIVE COMPARATOR

Willis gauge was used to determine the Length from Base of the nose to Base of the chin to record Vertical Dimensions of Occlusion

Procedure: Conventional method

Interventions

Vernier caliper was used to measure finger length

Finger Lengths

Gillis gauge was used to measure occlusal vertical dimension

Conventional method

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completely edentulous patients
  • Patients willing to participate in the study
  • Male patients without a beard

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 28600914BACKGROUND
  • Khan SA, Raza Kazmi SM, Ahmed S, Hani U, Choudhry Z, Sukkurwala A. Correlation of index finger length to vertical dimensions of occlusion for edentulous patients and their satisfaction: a randomized controlled trial. Sci Rep. 2023 May 7;13(1):7414. doi: 10.1038/s41598-023-33722-x.

MeSH Terms

Conditions

Patient SatisfactionJaw, Edentulous

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

  • Shujah A Khan, BDS

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2021

First Posted

December 10, 2021

Study Start

March 1, 2019

Primary Completion

July 1, 2019

Study Completion

March 1, 2020

Last Updated

December 10, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations