Patient SatisfactionNCT06148727
Evaluation of Masticatory Performance and Patient Satisfaction for Conventional and 3D Printed Implant Overdentures
A study testing Dental implant placement and Bar attachment in people with Patient Satisfaction, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this crossover clinical study was the evaluation and comparison of masticatory performance and patient satisfaction for patients rehabilitated with conventional heat cured acrylic resin and 3D printed mandibular implant overdentures retained with bar attachment. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Dental implant placement and Bar attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2023to 10 Aug 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adequate bone quantity [classes 1-3 according to [Lekholm and Zarb] of the mandible in the lateral incisor and first premolar regions to receive 4 implants
- adequate restorative space [12-15 mm from the mucosa of the mandibular ridge to the occlusal plane- Class I according to Ahuja and Cagna 23 for bar supported implant overdenture. This was verified by direct measurement of old denture
- Angel's class I maxillo-mandibular relationship.
Who cannot join
- include systemic diseases that contraindicate implant placement
- irradiation of the head and neck region
- chemotherapy within the past 3 years
- bone metabolic diseases as uncontrolled diabetes mellitus
- smoking habit
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this crossover clinical study was the evaluation and comparison of masticatory performance and patient satisfaction for patients rehabilitated with conventional heat cured acrylic resin and 3D printed mandibular implant overdentures retained with bar attachment.
it was concluded that 3D printed implant overdenture showed promising results regarding chewing efficiency and patient satisfaction compared to conventionally fabricated implant overdenture.
Read the detailed description
The aim of this crossover clinical study was the evaluation and comparison of masticatory performance and patient satisfaction for patients rehabilitated with conventional heat cured acrylic resin and 3D printed mandibular implant overdentures retained with bar attachment.
Materials and Methods: Twelve completely edentulous healthy participants received new conventional dentures. Four interforaminal implants were inserted in the mandible. After osseointegration, bar was constructed with trapezoidal configuration. Each patient received randomly the following overdentures using a crossover design: conventional heat cured acrylic resin overdenture, 3d printed overdenture ( developed by scanning of mandibular conventional overdenture). Masticatory performance was evaluated with the two-colour mixing ability test after 5, 10, 20, 30, and 50 masticatory cycles. Patient satisfaction was also measured using McGill Denture Satisfaction Questionnaire. Evaluation was done after 3 months of using each overdenture.
Conclusion: Within this clinical study limitations, 3D printed implant overdenture showed promising results regarding chewing efficiency and patient satisfaction compared to conventionally fabricated implant overdenture.
- Conditions
- Patient Satisfaction
- Being tested
- Dental implant placement, Bar attachment
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant placementDevice
Procedure/ surgery: Surgical placement of dental implants, four interforaminal dental implants were placed
Bar attachmentDevice
Device: attachment, implants were connected to each others by 3 implant assembly in a trapezoidal design implants were loaded after 3 months of osseo-integration Control Group: patients received coventionally constructed heat cured overdenture Study Group: patients received 3d printed overdenture
| Study group | Role | What they receive |
|---|---|---|
| Conventional heat cured overdenture group | Active comparator | patients received 4 interforamenal implants connected by 3 bar assembly and conventional heat cured overdenture (Control Group) Receives: Device: Dental implant placement; Device: Bar attachment |
| 3d- printed overdenture group | Active comparator | patients received 4 interforamenal implants connected by 3 bar assembly and 3d printed overdenture (Study Group) Receives: Device: Dental implant placement; Device: Bar attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chewing efficiency
Chewing efficiency was assessed using the previously documented two-color mixing ability test (colorimetric method) as follow: Two samples were prepared from two colored chewing gums. Patients were asked to keep the gum sample intraorally for one minute then start to chew it for 5, 10, 20, 30 and 50 strokes respectively. Five samples were used for the tests, the samples were spat into clear plastic bags. All samples were evaluated after flattening to wafers of 1 mm thickness. scanned by Digital scanner from both sides stored in Adobe Photoshop® format (psd). Then the color range tool and histogram function were used to pick out the unmixed white parts of the image. Then the ratio of Unmixed Fraction (UF) was computed using the following formula: (Pixels white side a + Pixels white side b) - 2× Pixels of scale / 2 × Pixels all. As a reference scale, a scanned piece of unmixed gum was copied in each image
Measured: at time of insertion of prosthesis T(0), 3 months after insertion T(3).
Patient satisfaction
The eight core of McGill Denture Satisfaction Questionnaire (MDSQ) items were used to record patient satisfaction with their mandibular complete removable denture. One question concerns overall satisfaction with existing prostheses, whereas the other seven questions refer to specific aspects that may influence overall satisfaction: ease of cleaning; ability to speak; comfort; aesthetics/appearance; and denture stability; chewing ability; chewing function. Respondents provided answers on a 100-mm visual analogue scale. Patients were encouraged to respond to the survey questionnaire after functioning with each type of denture for 3-months.
Measured: at time of insertion of prosthesis T(0), 3 months after insertion T(3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start14 Jan 2023
- Primary completion30 Jul 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Each patient received two prostheses; conventional and 3D-printed implant overdentures. The succession of complete denture insertion was randomized to diminish the effect of the order of complete denture use on the results. First, each denture was used for three months, followed by two weeks of rest; then, the other denture type was delivered to the patient and used for another three months.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed shady, Mansoura University
- Investigators
- Mohamed Shady, MD, Principal investigator, Mansoura University Faculty of Dentistry, Prosthodontics department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148727
- Sponsor's protocol ID
- A20011122
- Status last verified
- Nov 2023
- First submitted
- 16 Aug 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nabil MS, Mahanna FF, Said MM. Evaluation of masticatory performance and patient satisfaction for conventional and 3D-printed implant overdentures: a randomized crossover study. BMC Oral Health. 2024 Jun 8;24(1):672. doi: 10.1186/s12903-024-04389-1.
PubMed 38851676
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Masticatory Performance and Patient Satisfaction for Conventional and 3D Printed Implant Overdentures
- ClinicalTrials.gov ID
- NCT06148727
- Acronym / sponsor ID
- A20011122
- Conditions
- Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 14 Jan 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 28 Nov 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.
The aim of this crossover clinical study was the evaluation and comparison of masticatory performance and patient satisfaction for patients rehabilitated with conventional heat cured acrylic resin and 3D printed mandibular implant overdentures retained with bar attachment.
it was concluded that 3D printed implant overdenture showed promising results regarding chewing efficiency and patient satisfaction compared to conventionally fabricated implant overdenture.
Detailed description
The aim of this crossover clinical study was the evaluation and comparison of masticatory performance and patient satisfaction for patients rehabilitated with conventional heat cured acrylic resin and 3D printed mandibular implant overdentures retained with bar attachment.
Materials and Methods: Twelve completely edentulous healthy participants received new conventional dentures. Four interforaminal implants were inserted in the mandible. After osseointegration, bar was constructed with trapezoidal configuration. Each patient received randomly the following overdentures using a crossover design: conventional heat cured acrylic resin overdenture, 3d printed overdenture ( developed by scanning of mandibular conventional overdenture). Masticatory performance was evaluated with the two-colour mixing ability test after 5, 10, 20, 30, and 50 masticatory cycles. Patient satisfaction was also measured using McGill Denture Satisfaction Questionnaire. Evaluation was done after 3 months of using each overdenture.
Conclusion: Within this clinical study limitations, 3D printed implant overdenture showed promising results regarding chewing efficiency and patient satisfaction compared to conventionally fabricated implant overdenture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Each patient received two prostheses; conventional and 3D-printed implant overdentures. The succession of complete denture insertion was randomized to diminish the effect of the order of complete denture use on the results. First, each denture was used for three months, followed by two weeks of rest; then, the other denture type was delivered to the patient and used for another three months.
| Arm | Type | Receives |
|---|---|---|
| Conventional heat cured overdenture group | Active comparator | Device: Dental implant placement, Device: Bar attachmentpatients received 4 interforamenal implants connected by 3 bar assembly and conventional heat cured overdenture (Control Group) |
| 3d- printed overdenture group | Active comparator | Device: Dental implant placement, Device: Bar attachmentpatients received 4 interforamenal implants connected by 3 bar assembly and 3d printed overdenture (Study Group) |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adequate bone quantity [classes 1-3 according to [Lekholm and Zarb] of the mandible in the lateral incisor and first premolar regions to receive 4 implants
- adequate restorative space [12-15 mm from the mucosa of the mandibular ridge to the occlusal plane- Class I according to Ahuja and Cagna 23 for bar supported implant overdenture. This was verified by direct measurement of old denture
- Angel's class I maxillo-mandibular relationship.
Key exclusion criteria (5 listed)
- include systemic diseases that contraindicate implant placement
- irradiation of the head and neck region
- chemotherapy within the past 3 years
- bone metabolic diseases as uncontrolled diabetes mellitus
- smoking habit
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 |
|---|---|---|
| Dental implant placementProcedure/ surgery: Surgical placement of dental implants, four interforaminal dental implants were placed | Device | 3d- printed overdenture group, Conventional heat cured overdenture group |
| Bar attachmentDevice: attachment, implants were connected to each others by 3 implant assembly in a trapezoidal design implants were loaded after 3 months of osseo-integration Control Group: patients received coventionally constructed heat cured overdenture Study Group: patients received 3d printed overdenture | Device | 3d- printed overdenture group, Conventional heat cured overdenture group |
Primary outcome
Chewing efficiency
Time frame: at time of insertion of prosthesis T(0), 3 months after insertion T(3).
Chewing efficiency was assessed using the previously documented two-color mixing ability test (colorimetric method) as follow: Two samples were prepared from two colored chewing gums. Patients were asked to keep the gum sample intraorally for one minute then start to chew it for 5, 10, 20, 30 and 50 strokes respectively. Five samples were used for the tests, the samples were spat into clear plastic bags. All samples were evaluated after flattening to wafers of 1 mm thickness. scanned by Digital scanner from both sides stored in Adobe Photoshop® format (psd). Then the color range tool and histogram function were used to pick out the unmixed white parts of the image. Then the ratio of Unmixed Fraction (UF) was computed using the following formula: (Pixels white side a + Pixels white side b) - 2× Pixels of scale / 2 × Pixels all. As a reference scale, a scanned piece of unmixed gum was copied in each image
Patient satisfaction
Time frame: at time of insertion of prosthesis T(0), 3 months after insertion T(3).
The eight core of McGill Denture Satisfaction Questionnaire (MDSQ) items were used to record patient satisfaction with their mandibular complete removable denture. One question concerns overall satisfaction with existing prostheses, whereas the other seven questions refer to specific aspects that may influence overall satisfaction: ease of cleaning; ability to speak; comfort; aesthetics/appearance; and denture stability; chewing ability; chewing function. Respondents provided answers on a 100-mm visual analogue scale. Patients were encouraged to respond to the survey questionnaire after functioning with each type of denture for 3-months.
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 28 Nov 2023.
- Derived from this study: PubMed 38851676Nabil MS, Mahanna FF, Said MM. Evaluation of masticatory performance and patient satisfaction for conventional and 3D-printed implant overdentures: a randomized crossover study. BMC Oral Health. 2024 Jun 8;24(1):672. doi: 10.1186/s12903-024-04389-1.
- 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.
Mohamed Shady, MD principal investigator
Mansoura University Faculty of Dentistry, Prosthodontics department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant placement and Bar attachment in people with Patient Satisfaction, run by Mansoura University 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 3 inclusion and 5 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 28 Nov 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?
Chewing efficiency (time frame: at time of insertion of prosthesis T(0), 3 months after insertion T(3).). The study lists 2 primary outcomes in all. 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 NCT06148727, which also lists 1 linked publication.
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 28 Nov 2023.