Patient SatisfactionNCT05153213
Correlation of Length of Index Finger to Vertical Dimensions of Occlusion for Edentulous Patients
A study testing Finger lengths and Conventional method in people with Patient Satisfaction and Dental Prosthesis, run by Dow University of Health Sciences at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction, Dental Prosthesis, Edentulous Jaw
- What is being tested?
- Finger lengths and Conventional method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completely edentulous patients
- Patients willing to participate in the study
- Male patients without a beard
Who cannot join
- 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
Show all 9Show fewer
- Nose or chin deformity
- TMJ disorders (intracapsular/extracapsular)
- Heavy bulky chin area (double chin)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Patient Satisfaction, Dental Prosthesis, Edentulous Jaw
- Being tested
- Finger lengths, Conventional method
- Keywords
- Occlusal vertical dimension, edentulous patients,
- Medical subject headings
- Patient Satisfaction, Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger lengthsProcedure or surgery
Vernier caliper was used to measure finger length
Conventional methodProcedure or surgery
Gillis gauge was used to measure occlusal vertical dimension
| Study group | Role | What they receive |
|---|---|---|
| Finger Lengths | Experimental | Vernier caliper was used to determine the length of Index Finger to record Vertical Dimensions of Occlusion Receives: 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 Receives: Procedure: Conventional method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with Complete Dentures
Satisfaction with Complete Dentures after assessment of occlusal vertical dimension with Length of Index Finger
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start1 Mar 2019
- Primary completion1 Jul 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shujah Adil Khan, Dow University of Health Sciences
- Investigators
- Shujah A Khan, BDS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153213
- Sponsor's protocol ID
- SAKhanDowUHS
- Status last verified
- Dec 2021
- First submitted
- 23 Mar 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28600914Khan 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.
PubMed 37150797
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05153213
- Acronym / sponsor ID
- SAKhanDowUHS
- Conditions
- Patient Satisfaction, Dental Prosthesis, Edentulous Jaw
- Keywords
- Occlusal vertical dimension, edentulous patients,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finger Lengths | Experimental | Procedure: Finger lengthsVernier caliper was used to determine the length of Index Finger to record Vertical Dimensions of Occlusion |
| Conventional method | Active comparator | Procedure: Conventional methodWillis gauge was used to determine the Length from Base of the nose to Base of the chin to record Vertical Dimensions of Occlusion |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Completely edentulous patients
- Patients willing to participate in the study
- Male patients without a beard
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finger lengthsVernier caliper was used to measure finger length | Procedure or surgery | Finger Lengths |
| Conventional methodGillis gauge was used to measure occlusal vertical dimension | Procedure or surgery | Conventional method |
Primary outcome
Satisfaction with Complete Dentures
Time frame: 6 Months
Satisfaction with Complete Dentures after assessment of occlusal vertical dimension with Length of Index Finger
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Background: PubMed 28600914Alhajj 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.
- Derived from this study: PubMed 37150797Khan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shujah A Khan, BDS principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finger lengths and Conventional method in people with Patient Satisfaction and Dental Prosthesis, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with Complete Dentures (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05153213, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.