Implant Site ReactionNCT05999760
Retention, Chewing Efficiency and Masticatory Performance of Partial Dentures Opposing Implant Retained Prosthesis.
A study testing evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge, chewing efficiency by electromyograph(E.M.G) and masticatory performance(questionnaire) in people with Implant Site Reaction and Implant Complication, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
This study aims to evaluate retention ,chewing efficiency and masticatory performance of flexible versus CAD/CAM partial dentures opposing to fixed implant retained restorations. Read more about this study
- Who is it for?
- Ages 40 to 50 years, men only
- Conditions the study is for
- Implant Site Reaction, Implant Complication
- What is being tested?
- evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge, chewing efficiency by electromyograph(E.M.G) and masticatory performance(questionnaire)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2022to 20 Jan 2023
- 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 40 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Non-smoker male Patients
- Age ranging from 40-50 years.
- Highly cooperative and motivated patients.
- Patients Systemically free from any immunosuppressive diseases.
- Patients free from Diabetes, Hypertension, Cancer, any mental or physical diseases.
- Patients not receiving any Radiotherapy or chemotherapy treatment.
Who cannot join
- Female patients
- Smoker patients.
- Age exceeding 50 years
- Uncooperative and unmotivated patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retention, Chewing Efficiency and Masticatory Performance of Maxillary Flexible Versus Computer Aided Design/Computer Aided Manufacture(CAD/CAM) Partial Dentures Opposing Fixed Implant Retained Prosthesis.
This study aims to evaluate retention ,chewing efficiency and masticatory performance of flexible versus CAD/CAM partial dentures opposing to fixed implant retained restorations.
Read the detailed description
in this study 22 patients will be selected following inclusion and exclusion criteria. The patients will be divided randomly into two groups.
Group I patients will receive Versacrylic removable partial denture. group II patients will receive CAD/CAM removable partial denture all patients will be given the home care instructions at night and brush cleaning of the dentures.
Measurements of retention using universal testing machine, masticatory performance using T-scan III computerized system and chewing efficiency using chewing function questionnaire
- Conditions
- Implant Site Reaction, Implant Complication
- Being tested
- evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge, chewing efficiency by electromyograph(E.M.G), masticatory performance(questionnaire)
- Keywords
- Retention, Chewing efficiency, Removable Prosthodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of retention of Versacryle and CAD/CAM partial dentures by force gaugeDevice
Evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge on day one, on first month, and on the second month of prosthesis delivery.
chewing efficiency by electromyograph(E.M.G)Device
Evaluation of chewing efficiency of Versacryle and CAD/CAM partial dentures by force gauge on day one, on first month, and on the second month of prosthesis delivery.
masticatory performance(questionnaire)Other
Evaluation of masticatory performance of Versacryle and CAD/CAM partial dentures by questionnaire on day one, on first month, and on the second month of prosthesis delivery.
| Study group | Role | What they receive |
|---|---|---|
| Group I (patients received Versacryle removable partial denture) | Active comparator | patients having Kennedy class I received maxillary Versacryle removable partial denture Receives: Device: evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge; Device: chewing efficiency by electromyograph(E.M.G); Other: masticatory performance(questionnaire) |
| Group II (patients received CAD/CAM fabricated removable partial denture) | Active comparator | patients having Kennedy class I received maxillary CAD/CAM fabricated removable partial denture Receives: Device: evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge; Device: chewing efficiency by electromyograph(E.M.G); Other: masticatory performance(questionnaire) |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of change of retention of versacrylic and CAD/CAM partial denture
measurement of retention of partial dentures made of Versacryle and CAD/CAM technology
Measured: on day 1 ,1 month and 2months of prosthesis delivery
evaluation of change of chewing efficiency of versacrylic and CAD/CAM partial denture
measurement of chewing efficiency of partial dentures made of Versacryle and CAD/CAM technology
Measured: on day 1 ,1 month and 2months of prosthesis delivery
evaluation of change of masticatory performance of versacrylic and CAD/CAM partial denture
measurement of masticatory performance of partial dentures made of Versacryle and CAD/CAM technology
Measured: on day 1,1 month and 2months of prosthesis delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start15 Nov 2022
- Primary completion15 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menatallah Mohamed Elhotieby, National Research Centre, Egypt
- Investigators
- Menatallah Elhotieby, Researcher, Principal investigator, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999760
- Sponsor's protocol ID
- Elhotieby.M
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention, Chewing Efficiency and Masticatory Performance of Maxillary Flexible Versus Computer Aided Design/Computer Aided Manufacture(CAD/CAM) Partial Dentures Opposing Fixed Implant Retained Prosthesis.
- ClinicalTrials.gov ID
- NCT05999760
- Acronym / sponsor ID
- Elhotieby.M
- Conditions
- Implant Site Reaction, Implant Complication
- Keywords
- Retention, Chewing efficiency, Removable Prosthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 21 Aug 2023 (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 aims to evaluate retention ,chewing efficiency and masticatory performance of flexible versus CAD/CAM partial dentures opposing to fixed implant retained restorations.
Detailed description
in this study 22 patients will be selected following inclusion and exclusion criteria. The patients will be divided randomly into two groups.
Group I patients will receive Versacrylic removable partial denture. group II patients will receive CAD/CAM removable partial denture all patients will be given the home care instructions at night and brush cleaning of the dentures.
Measurements of retention using universal testing machine, masticatory performance using T-scan III computerized system and chewing efficiency using chewing function questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (patients received Versacryle removable partial denture) | Active comparator | Device: evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge, Device: chewing efficiency by electromyograph(E.M.G), Other: masticatory performance(questionnaire)patients having Kennedy class I received maxillary Versacryle removable partial denture |
| Group II (patients received CAD/CAM fabricated removable partial denture) | Active comparator | Device: evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge, Device: chewing efficiency by electromyograph(E.M.G), Other: masticatory performance(questionnaire)patients having Kennedy class I received maxillary CAD/CAM fabricated removable partial denture |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-smoker male Patients
- Age ranging from 40-50 years.
- Highly cooperative and motivated patients.
- Patients Systemically free from any immunosuppressive diseases.
- Patients free from Diabetes, Hypertension, Cancer, any mental or physical diseases.
Key exclusion criteria (4 listed)
- Female patients
- Smoker patients.
- Age exceeding 50 years
- Uncooperative and unmotivated patients.
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 |
|---|---|---|
| evaluation of retention of Versacryle and CAD/CAM partial dentures by force gaugeEvaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge on day one, on first month, and on the second month of prosthesis delivery. | Device | Group I (patients received Versacryle removable partial denture), Group II (patients received CAD/CAM fabricated removable partial denture) |
| chewing efficiency by electromyograph(E.M.G)Evaluation of chewing efficiency of Versacryle and CAD/CAM partial dentures by force gauge on day one, on first month, and on the second month of prosthesis delivery. | Device | Group I (patients received Versacryle removable partial denture), Group II (patients received CAD/CAM fabricated removable partial denture) |
| masticatory performance(questionnaire)Evaluation of masticatory performance of Versacryle and CAD/CAM partial dentures by questionnaire on day one, on first month, and on the second month of prosthesis delivery. | Other | Group I (patients received Versacryle removable partial denture), Group II (patients received CAD/CAM fabricated removable partial denture) |
Primary outcome
evaluation of change of retention of versacrylic and CAD/CAM partial denture
Time frame: on day 1 ,1 month and 2months of prosthesis delivery
measurement of retention of partial dentures made of Versacryle and CAD/CAM technology
evaluation of change of chewing efficiency of versacrylic and CAD/CAM partial denture
Time frame: on day 1 ,1 month and 2months of prosthesis delivery
measurement of chewing efficiency of partial dentures made of Versacryle and CAD/CAM technology
evaluation of change of masticatory performance of versacrylic and CAD/CAM partial denture
Time frame: on day 1,1 month and 2months of prosthesis delivery
measurement of masticatory performance of partial dentures made of Versacryle and CAD/CAM technology
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 21 Aug 2023.
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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.
Menatallah Elhotieby, Researcher principal investigator
National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge, chewing efficiency by electromyograph(E.M.G) and masticatory performance(questionnaire) in people with Implant Site Reaction and Implant Complication, run by National Research Centre, Egypt at 1 site in Egypt.
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 6 inclusion and 4 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 21 Aug 2023. 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 Egypt. 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?
evaluation of change of retention of versacrylic and CAD/CAM partial denture (time frame: on day 1 ,1 month and 2months of prosthesis delivery). The study lists 3 primary outcomes in all. 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 21 Aug 2023; AzTrials last refreshed its copy on 1 Nov 2026.