Dental ProsthesisNCT06929689
Evaluation of the All-on-three Concept in Mandible.
A study testing three dental implants in people with Dental Prosthesis and Dental Implant, run by Alexandria University at 1 site in Egypt.
Trial summary
Evaluation of the clinical and radiographic treatment outcomes of immediately loaded three implants by fixed-detachable prostheses for the management of totally edentulous mandibles. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Prosthesis, Dental Implant
- What is being tested?
- three dental implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Mar 2022to 9 Feb 2025
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completely edentulous patients with skeletal Class I maxilla-mandibular relationship.
- Adequate inter-arch space (22 mm), measured using the "try in" before any intervention.
- Male or female patients aged between 40 and 60 years.
- Maxillary and mandibular ridges with no history of recent extraction.
- Mandibular ridge should be ≥15 mm in height and ≥7 mm in width to accommodate three implants in the intra-foramina area of the mandibular arch, verified by using cone beam computed tomography (CBCT).
Who cannot join
- History of radiotherapy in the head and neck region.
- History of hard tissue augmentation.
- Presence of any intra-oral pathological condition.
- Any medical disorder that could complicate the surgical phase or affect osseointegration, such as osteoporosis, uncontrolled diabetes, and hypertension.
- Smoker and bruxer patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of All-on-three Immediately Loaded Mandibular Fixed Detachable Restorations (a Clinical Trial)
Evaluation of the clinical and radiographic treatment outcomes of immediately loaded three implants by fixed-detachable prostheses for the management of totally edentulous mandibles.
The hypothesis is that mandibular immediately loaded fixed detachable restorations supported only by three implants in the inter-foraminal region will not adversely affect the clinical or radiographical treatment outcome.
Read the detailed description
The ideal amount of implants for edentulous mandible rehabilitation continues to be a subject of scholarly debate. Traditionally, at least four implants are required for fixed detachable prostheses, but increasing implant numbers raises costs and complexity, leading to patient reluctance. Reducing the number to three implants may simplify surgery, minimize trauma, and encourage patient acceptance.
- Conditions
- Dental Prosthesis, Dental Implant
- Being tested
- three dental implants
- Keywords
- Three implants, Fixed detachable restorations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
three dental implantsProcedure or surgery
fixed detachable prosthesis
| Study group | Role | What they receive |
|---|---|---|
| completely edentulous patients | Experimental | fixed detachable restorations on three dental implants in the mandible Receives: Procedure: three dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic evaluation
The level of alveolar bone around each implant was evaluated using CBCT. Radiographic assessment of the vertical bone change around each implant was measured and the mean value was calculated. Bone measurements was evaluated at the insertion time then it was evaluated regularly 6 months and 12 months.
Measured: 12 months
Peri-Implant Probing Depth (PIPD)
Peri-implant probing depth refers to the distance between the gingival margin and the most apically probable portion in millimeters (mm). The peri-implant sulcus depth was measured using a graduated plastic periodontal probe. The probe was held parallel to the long axis of the implant and introduced to the peri-implant sulcus with slight pressure. Measurements was made at four sites around each implant; buccal, lingual, mesial and distal. Probing depth of 1 mm or less was recorded as "1mm", and those exceeding 1 mm but less than 2 mm was recorded as "2mm" and so forth. The mean records for each implant was then calculated.
Measured: 12 months
Clinical Attachment level (CAL)
It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters. Assessment of the clinical attachment level was performed simultaneously while measuring the peri-implant probing depth.
Measured: 12 months
Implant stability
Mobility (implant stability) was measured by using RFA (Osstell device instrument). The Osstell unit record numeric value of 1-100 which is referred to as the implant stability quotient (ISQ). The larger the ISQ value recorded indicates the more stable the implant-bone interface. Initial stability was checked at the insertion time then it was evaluated regularly, 6 months and 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start19 Mar 2022
- Primary completion8 Jun 2023
- Study completion9 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ProsthesisStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naema Ammar, Alexandria University
- Investigators
- Ahmed M Abdelhamid, PhD, Study chair, Alexandria UniversityEnaya Sharara, PhD, Study chair, Alexandria UniversityRania A Fahmy, PhD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929689
- Sponsor's protocol ID
- all-on-three
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of All-on-three Immediately Loaded Mandibular Fixed Detachable Restorations (a Clinical Trial)
- ClinicalTrials.gov ID
- NCT06929689
- Acronym / sponsor ID
- all-on-three
- Conditions
- Dental Prosthesis, Dental Implant
- Keywords
- Three implants, Fixed detachable restorations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 19 Mar 2022 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 9 Feb 2025 (actual)
- First posted
- 16 Apr 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.
Evaluation of the clinical and radiographic treatment outcomes of immediately loaded three implants by fixed-detachable prostheses for the management of totally edentulous mandibles.
The hypothesis is that mandibular immediately loaded fixed detachable restorations supported only by three implants in the inter-foraminal region will not adversely affect the clinical or radiographical treatment outcome.
Detailed description
The ideal amount of implants for edentulous mandible rehabilitation continues to be a subject of scholarly debate. Traditionally, at least four implants are required for fixed detachable prostheses, but increasing implant numbers raises costs and complexity, leading to patient reluctance. Reducing the number to three implants may simplify surgery, minimize trauma, and encourage patient acceptance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| completely edentulous patients | Experimental | Procedure: three dental implantsfixed detachable restorations on three dental implants in the mandible |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Completely edentulous patients with skeletal Class I maxilla-mandibular relationship.
- Adequate inter-arch space (22 mm), measured using the "try in" before any intervention.
- Male or female patients aged between 40 and 60 years.
- Maxillary and mandibular ridges with no history of recent extraction.
- Mandibular ridge should be ≥15 mm in height and ≥7 mm in width to accommodate three implants in the intra-foramina area of the mandibular arch, verified by using cone beam computed tomography (CBCT).
Key exclusion criteria (5 listed)
- History of radiotherapy in the head and neck region.
- History of hard tissue augmentation.
- Presence of any intra-oral pathological condition.
- Any medical disorder that could complicate the surgical phase or affect osseointegration, such as osteoporosis, uncontrolled diabetes, and hypertension.
- Smoker and bruxer 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 |
|---|---|---|
| three dental implantsfixed detachable prosthesis | Procedure or surgery | completely edentulous patients |
Primary outcome
Radiographic evaluation
Time frame: 12 months
The level of alveolar bone around each implant was evaluated using CBCT. Radiographic assessment of the vertical bone change around each implant was measured and the mean value was calculated. Bone measurements was evaluated at the insertion time then it was evaluated regularly 6 months and 12 months.
Peri-Implant Probing Depth (PIPD)
Time frame: 12 months
Peri-implant probing depth refers to the distance between the gingival margin and the most apically probable portion in millimeters (mm). The peri-implant sulcus depth was measured using a graduated plastic periodontal probe. The probe was held parallel to the long axis of the implant and introduced to the peri-implant sulcus with slight pressure. Measurements was made at four sites around each implant; buccal, lingual, mesial and distal. Probing depth of 1 mm or less was recorded as "1mm", and those exceeding 1 mm but less than 2 mm was recorded as "2mm" and so forth. The mean records for each implant was then calculated.
Clinical Attachment level (CAL)
Time frame: 12 months
It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters. Assessment of the clinical attachment level was performed simultaneously while measuring the peri-implant probing depth.
Implant stability
Time frame: 12 months
Mobility (implant stability) was measured by using RFA (Osstell device instrument). The Osstell unit record numeric value of 1-100 which is referred to as the implant stability quotient (ISQ). The larger the ISQ value recorded indicates the more stable the implant-bone interface. Initial stability was checked at the insertion time then it was evaluated regularly, 6 months and 12 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 16 Apr 2025.
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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.
Ahmed M Abdelhamid, PhD study chair
Alexandria University
Enaya Sharara, PhD study chair
Alexandria University
Rania A Fahmy, PhD study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing three dental implants in people with Dental Prosthesis and Dental Implant, run by Alexandria 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 5 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 16 Apr 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 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?
Radiographic evaluation (time frame: 12 months). The study lists 4 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 16 Apr 2025.