- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06811818
Masticatory Performance in Bilateral Balanced Occlusion and Lingualized Occlusion in Complete Denture
February 2, 2025 updated by: Seema Khattak, Armed Forces Institute of Dentistry, Pakistan
Comparison of Masticatory Performance of Bilateral Balanced Occlusion and Lingualized Occlusion in Complete Denture Patients
This is a randomized control trial to compare masticatory performance in complete dentures with bilateral balanced occlusion or lingualized occlusion.
Study Overview
Status
Completed
Conditions
Detailed Description
This study is a randomized control trial to compare the masticatory efficiency of complete dentures with bilateral balanced occlusion with that of lingualized occlusion .
Grouping of participants was carried out.
Participants divided into two groups one receiving complete dentures with bilateral balanced occlusion and the other group receiving complete dentures with lingualized occlusion .
Each participant provided with 15g of peanuts and instructed to chew until ready to swallow .
The chew material than spat into the designated container and participants asked to rinse their mouth with water , with the rinse being collected in the same container .
The collected material than sieved through 10-Mesh sieve followed by drying the sieved content on blotting paper for 30 minutes.
The dried material subsequently weight with an electric balance with precision of 0.01 grams .
Masticatory efficiency assessed through mean weight of chewed peanuts.
Study Type
Interventional
Enrollment (Actual)
146
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Armed Forces Institute of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Participants aged 45-65 years.
- Both genders included.
- Edentulous patients requiring complete denture.
- Patients willing to participate in the study .
Exclusion Criteria:
- Participants not willing to participate in the study.
- Participants with systemic disease .
- Participants with neuromuscular disorders .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: complete denture with bilateral balanced occlusion
|
Participants in this group will be given complete dentures with bilateral balanced occlusion
|
|
Active Comparator: complete denture with lingualized occlusion
|
Participants in this group will be given complete dentures with lingualized occlusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Masticatory Efficiency in Complete Dentures by weighing the dried chewed material through electric balance
Time Frame: upto 24 weeks
|
The chewed material that has been sieved through 10-mesh sieve and dried through blotting paper for 30 minutes weighted using an electronic balance with a precision of 0.01 grams .
Statistical analysis performed to evaluate masticatory efficiency based on the mean weight of chewed peanuts.
|
upto 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Seema Khattak, BDS, Armed Forces Institute of Dentistry
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2024
Primary Completion (Actual)
December 30, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
January 19, 2025
First Submitted That Met QC Criteria
February 2, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 2, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- masticatory performance
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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