Prosthesis DurabilityNCT05290766
Two Versus Four Implant-supported Fixed Full-arch Prosthesis
A study testing placement of four dental implants, placement of two dental implants and mandibular full arch prosthesis in people with Prosthesis Durability, run by Mansoura University at 2 sites in Egypt.
Trial summary
The aim of this study will be the evaluation of patient satisfaction and oral health-related-quality of life (OHRQoL) of two versus four implants supporting fixed full-arch screw-retained metal acrylic hybrid mandibular prosthesis. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Durability
- What is being tested?
- placement of four dental implants, placement of two dental implants and mandibular full arch prosthesis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 4 Jan 2022to 16 Apr 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Eligible patients needed must have Sufficient interarch space (at least 15 mm from the occlusal plane to the mandibular ridge) to provide space for fixed prosthesis construction all patients should be completely edentulous patients with resorbed mandibular ridge all patients must be angle class I
Who cannot join
- systemic diseases that contraindicate implant placement bone metabolic diseases such as diabetes mellitus irradiation of the head and neck region chemotherapy within the past 3 years smoking habits.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Dentistry, Mansoura University
Al Mansurah, Eldakahlia, 35516
Christine Ibrahim
Al Mansurah, P.O.Box:35516
About this study
Official title: Two Versus Four Implant Supporting Fixed Full-arch Screw-retained Metal Acrylic Hybrid Mandibular Prosthesis.(A Study of Patient Satisfaction)
The aim of this study will be the evaluation of patient satisfaction and oral health-related-quality of life (OHRQoL) of two versus four implants supporting fixed full-arch screw-retained metal acrylic hybrid mandibular prosthesis.
Read the detailed description
- Six completely edentulous patients will be selected for this study from the outpatient clinic of the prosthodontic department
- All patients will be informed about all surgical and prosthodontics procedures that will be done for them. All patients will sign the consent form of the ethical committee in faculty dentistry Mansoura University.
The patients will be divided into 2 groups
- Control group: will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".
- Study group: will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".
- Conditions
- Prosthesis Durability
- Being tested
- placement of four dental implants, placement of two dental implants, mandibular full arch prosthesis
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placement of four dental implantsProcedure or surgery
placement of four dental implants according to the " All on four concept"
placement of two dental implantsProcedure or surgery
placement of two dental implants according to " All on two concepts"
mandibular full arch prosthesisDevice
loading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept". Receives: Procedure: placement of four dental implants; Device: mandibular full arch prosthesis |
| Study group | Active comparator | will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept". Receives: Procedure: placement of two dental implants; Device: mandibular full arch prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) questionnaire
Regarding VAS, participants were asked to score their answer according to the amount of satisfaction on a 100mm line (Score zero = no satisfaction at all and score 100 = complete satisfaction). The questions cover several items related to prosthesis such as: retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus and appearance
Measured: one year
Secondary outcomes (1)
Quality of Life (Secondary Outcome).
The oral Health impact profile (OHIP-14) questions were utilized to assess OHRQoL. The questions were composed of seven domains
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start4 Jan 2022
- Primary completion7 Nov 2022
- Study completion16 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis DurabilityStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290766
- Sponsor's protocol ID
- A03040122
- Status last verified
- Apr 2023
- First submitted
- 2 Mar 2022
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Versus Four Implant Supporting Fixed Full-arch Screw-retained Metal Acrylic Hybrid Mandibular Prosthesis.(A Study of Patient Satisfaction)
- ClinicalTrials.gov ID
- NCT05290766
- Acronym / sponsor ID
- A03040122
- Conditions
- Prosthesis Durability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 16 Apr 2023 (actual)
- First posted
- 22 Mar 2022 (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 study will be the evaluation of patient satisfaction and oral health-related-quality of life (OHRQoL) of two versus four implants supporting fixed full-arch screw-retained metal acrylic hybrid mandibular prosthesis.
Detailed description
- Six completely edentulous patients will be selected for this study from the outpatient clinic of the prosthodontic department
- All patients will be informed about all surgical and prosthodontics procedures that will be done for them. All patients will sign the consent form of the ethical committee in faculty dentistry Mansoura University.
The patients will be divided into 2 groups
- Control group: will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".
- Study group: will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: placement of four dental implants, Device: mandibular full arch prosthesiswill receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept". |
| Study group | Active comparator | Procedure: placement of two dental implants, Device: mandibular full arch prosthesiswill receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept". |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Eligible patients needed must have Sufficient interarch space (at least 15 mm from the occlusal plane to the mandibular ridge) to provide space for fixed prosthesis construction all patients should be completely edentulous patients with resorbed mandibular ridge all patients must be angle class I
Key exclusion criteria (1 listed)
- systemic diseases that contraindicate implant placement bone metabolic diseases such as diabetes mellitus irradiation of the head and neck region chemotherapy within the past 3 years smoking habits.
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 |
|---|---|---|
| placement of four dental implantsplacement of four dental implants according to the " All on four concept" | Procedure or surgery | Control group |
| placement of two dental implantsplacement of two dental implants according to " All on two concepts" | Procedure or surgery | Study group |
| mandibular full arch prosthesisloading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis | Device | Control group, Study group |
Primary outcome
Visual analog scale (VAS) questionnaire
Time frame: one year
Regarding VAS, participants were asked to score their answer according to the amount of satisfaction on a 100mm line (Score zero = no satisfaction at all and score 100 = complete satisfaction). The questions cover several items related to prosthesis such as: retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus and appearance
1 secondary outcome
Quality of Life (Secondary Outcome).
Time frame: one year
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 17 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing placement of four dental implants, placement of two dental implants and mandibular full arch prosthesis in people with Prosthesis Durability, run by Mansoura University at 2 sites 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 1 inclusion and 1 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 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Visual analog scale (VAS) questionnaire (time frame: one year). 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 17 Jan 2025.