Masticatory PerformanceNCT06811818
Masticatory Performance in Bilateral Balanced Occlusion and Lingualized Occlusion in Complete Denture
A study testing complete denture with bilateral balanced occlusion and complete denture with lingualized occlusion in people with Masticatory Performance, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
This is a randomized control trial to compare masticatory performance in complete dentures with bilateral balanced occlusion or lingualized occlusion. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Masticatory Performance
- What is being tested?
- complete denture with bilateral balanced occlusion and complete denture with lingualized occlusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2024to 31 Dec 2024
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants aged 45-65 years.
- Both genders included.
- Edentulous patients requiring complete denture.
- Patients willing to participate in the study .
Who cannot join
- Participants not willing to participate in the study.
- Participants with systemic disease .
- Participants with neuromuscular disorders .
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed Forces Institute Of Dentistry
Rawalpindi, Punjab Province, 46000
About this study
Official title: 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.
Read the 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.
- Conditions
- Masticatory Performance
- Being tested
- complete denture with bilateral balanced occlusion, complete denture with lingualized occlusion
- Keywords
- Masticatory performance , Bilateral balanced occlusion , Lingualized occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete denture with bilateral balanced occlusionOther
Participants in this group will be given complete dentures with bilateral balanced occlusion
complete denture with lingualized occlusionOther
Participants in this group will be given complete dentures with lingualized occlusion
| Study group | Role | What they receive |
|---|---|---|
| complete denture with bilateral balanced occlusion | Active comparator | complete denture with bilateral balanced occlusion Receives: Other: complete denture with bilateral balanced occlusion |
| complete denture with lingualized occlusion | Active comparator | complete denture with lingualized occlusion Receives: Other: complete denture with lingualized occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masticatory Efficiency in Complete Dentures by weighing the dried chewed material through electric balance
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.
Measured: upto 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Jul 2024
- Primary completion30 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Masticatory PerformanceStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seema Khattak, Armed Forces Institute of Dentistry, Pakistan
- Investigators
- Seema Khattak, BDS, Principal investigator, Armed Forces Institute of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811818
- Sponsor's protocol ID
- masticatory performance
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Masticatory Performance of Bilateral Balanced Occlusion and Lingualized Occlusion in Complete Denture Patients
- ClinicalTrials.gov ID
- NCT06811818
- Acronym / sponsor ID
- masticatory performance
- Conditions
- Masticatory Performance
- Keywords
- Masticatory performance , Bilateral balanced occlusion , Lingualized occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Feb 2025 (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 is a randomized control trial to compare masticatory performance in complete dentures with bilateral balanced occlusion or lingualized occlusion.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete denture with bilateral balanced occlusion | Active comparator | Other: complete denture with bilateral balanced occlusioncomplete denture with bilateral balanced occlusion |
| complete denture with lingualized occlusion | Active comparator | Other: complete denture with lingualized occlusioncomplete denture with lingualized occlusion |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged 45-65 years.
- Both genders included.
- Edentulous patients requiring complete denture.
- Patients willing to participate in the study .
Key exclusion criteria (3 listed)
- Participants not willing to participate in the study.
- Participants with systemic disease .
- Participants with neuromuscular disorders .
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 |
|---|---|---|
| complete denture with bilateral balanced occlusionParticipants in this group will be given complete dentures with bilateral balanced occlusion | Other | complete denture with bilateral balanced occlusion |
| complete denture with lingualized occlusionParticipants in this group will be given complete dentures with lingualized occlusion | Other | complete denture with lingualized occlusion |
Primary outcome
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.
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 6 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Masticatory Performance
Not yet recruiting
Evaluation of Occlusal Force and Masticatory Function in Children With Molar-Incisor Hypomineralization
Molar-Incisor Hypomineralization (MIH), Masticatory Performance
RecruitingObservational study
Masticatory Performance Evaluation
Masticatory Performance
Enrolling by invitation
Prosthetic Rehabilitation and Its Influence on Masticatory Performance and QoL in Patients Treated for HNC
Quality of Life, Objective Masticatory Performance
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.
Seema Khattak, BDS principal investigator
Armed Forces Institute of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing complete denture with bilateral balanced occlusion and complete denture with lingualized occlusion in people with Masticatory Performance, run by Armed Forces Institute of Dentistry, Pakistan 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 4 inclusion and 3 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 6 Feb 2025. 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?
Masticatory Efficiency in Complete Dentures by weighing the dried chewed material through electric balance (time frame: upto 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.