Jaw, EdentulousNCT07824219
Tri-Lobe vs. Hexagonal Connections in Immediately Loaded Mandibular Overdentures
A study testing ReActive Implant System (Internal Tri-Lobe Platform) and Legacy II Implant System (Internal Hexagonal Platform) in people with Jaw, Edentulous and Edentulism, Complete, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial summary
Objective: Compare changes in crestal bone height and peri-implant bone density using cone-beam computed tomography (CBCT) at baseline, 6 months, and 12 months post-placement. Participants \& Setup: 14 fully edentulous male patients (aged 45-60) received two mandibular canine implants. Read more about this study
- Who is it for?
- Ages 45 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Edentulism, Complete, Peri-implant Bone Loss
- What is being tested?
- ReActive Implant System (Internal Tri-Lobe Platform) and Legacy II Implant System (Internal Hexagonal Platform)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Dec 2024to 1 May 2026
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participants aged 45-60 years who are completely edentulous in both arches; presentation of a normal ridge relationship with D2 bone quality and Type A or B bone quantity; provision of written informed consent.
Who cannot join
- Systemic conditions affecting bone metabolism; heavy smoking; poorly controlled diabetes; history of radiotherapy or chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peri-Implant Bone Changes Associated With Internal Tri-Lobe Versus Internal Hexagonal Implant-Abutment Connections in Immediately Loaded Mandibular Overdentures: A One-Year CBCT Clinical Study
Objective: Compare changes in crestal bone height and peri-implant bone density using cone-beam computed tomography (CBCT) at baseline, 6 months, and 12 months post-placement.
Participants \& Setup: 14 fully edentulous male patients (aged 45-60) received two mandibular canine implants. Comparison Groups: Group I (n = 7) received internal tri-lobe implants (ReActive System), and Group II (n = 7) received internal hexagonal implants (Legacy II System).
Intervention: Implants were immediately loaded with ball attachments to retain lower overdentures.
- Being tested
- ReActive Implant System (Internal Tri-Lobe Platform), Legacy II Implant System (Internal Hexagonal Platform)
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReActive Implant System (Internal Tri-Lobe Platform)Device
Bilateral surgical placement of two 3.7 × 13 mm tapered, threaded titanium-alloy dental implants featuring a Soluble Blast Media (SBM) textured surface and a color-coded internal tri-lobe platform in the mandibular canine regions. Implants are placed using a one-stage, non-submerged surgical technique and fitted with metallic ball abutments (2 mm cuff). Implants are immediately loaded to retain a mandibular complete overdenture picked up directly with self-curing acrylic resin.
Legacy II Implant System (Internal Hexagonal Platform)Device
Bilateral surgical placement of two 3.7 × 13 mm tapered, threaded titanium-alloy dental implants featuring a Soluble Blast Media (SBM) textured surface and an internal hexagonal platform in the mandibular canine regions. Implants are placed using a one-stage, non-submerged surgical technique and fitted with metallic ball abutments (2 mm cuff). Implants are immediately loaded to retain a mandibular complete overdenture picked up directly with self-curing acrylic resin.
| Study group | Role | What they receive |
|---|---|---|
| Internal Tri-Lobe Connection | Experimental | Patients fitted with the ReActive Implant System (internal tri-lobe platform). Receives: Device: ReActive Implant System (Internal Tri-Lobe Platform) |
| Internal Hexagonal Connection | Active comparator | Patients fitted with the Legacy II Implant System (internal hexagonal platform). Receives: Device: Legacy II Implant System (Internal Hexagonal Platform) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peri-Implant Crestal Bone Height
Measured: Baseline (implant placement), 6 months, and 12 months
Secondary outcomes (1)
Change in Peri-Implant Bone Density
Measured: Baseline (implant placement), 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Dec 2024
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, EdentulousStudies 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
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Zaarour, Gulf Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824219
- Sponsor's protocol ID
- 24-08/2
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Implant Bone Changes Associated With Internal Tri-Lobe Versus Internal Hexagonal Implant-Abutment Connections in Immediately Loaded Mandibular Overdentures: A One-Year CBCT Clinical Study
- ClinicalTrials.gov ID
- NCT07824219
- Acronym / sponsor ID
- 24-08/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 17 Sep 2026 (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.
Objective: Compare changes in crestal bone height and peri-implant bone density using cone-beam computed tomography (CBCT) at baseline, 6 months, and 12 months post-placement.
Participants \& Setup: 14 fully edentulous male patients (aged 45-60) received two mandibular canine implants. Comparison Groups: Group I (n = 7) received internal tri-lobe implants (ReActive System), and Group II (n = 7) received internal hexagonal implants (Legacy II System).
Intervention: Implants were immediately loaded with ball attachments to retain lower overdentures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal Tri-Lobe Connection | Experimental | Device: ReActive Implant System (Internal Tri-Lobe Platform)Patients fitted with the ReActive Implant System (internal tri-lobe platform). |
| Internal Hexagonal Connection | Active comparator | Device: Legacy II Implant System (Internal Hexagonal Platform)Patients fitted with the Legacy II Implant System (internal hexagonal platform). |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male participants aged 45-60 years who are completely edentulous in both arches; presentation of a normal ridge relationship with D2 bone quality and Type A or B bone quantity; provision of written informed consent.
Key exclusion criteria (1 listed)
- Systemic conditions affecting bone metabolism; heavy smoking; poorly controlled diabetes; history of radiotherapy or chemotherapy.
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 |
|---|---|---|
| ReActive Implant System (Internal Tri-Lobe Platform)Bilateral surgical placement of two 3.7 × 13 mm tapered, threaded titanium-alloy dental implants featuring a Soluble Blast Media (SBM) textured surface and a color-coded internal tri-lobe platform in the mandibular canine regions. Implants are placed using a one-stage, non-submerged surgical technique and fitted with metallic ball abutments (2 mm cuff). Implants are immediately loaded to retain a mandibular complete overdenture picked up directly with self-curing acrylic resin. | Device | Internal Tri-Lobe Connection |
| Legacy II Implant System (Internal Hexagonal Platform)Bilateral surgical placement of two 3.7 × 13 mm tapered, threaded titanium-alloy dental implants featuring a Soluble Blast Media (SBM) textured surface and an internal hexagonal platform in the mandibular canine regions. Implants are placed using a one-stage, non-submerged surgical technique and fitted with metallic ball abutments (2 mm cuff). Implants are immediately loaded to retain a mandibular complete overdenture picked up directly with self-curing acrylic resin. | Device | Internal Hexagonal Connection |
Primary outcome
Change in Peri-Implant Crestal Bone Height
Time frame: Baseline (implant placement), 6 months, and 12 months
1 secondary outcome
Change in Peri-Implant Bone Density
Time frame: Baseline (implant placement), 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 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReActive Implant System (Internal Tri-Lobe Platform) and Legacy II Implant System (Internal Hexagonal Platform) in people with Jaw, Edentulous and Edentulism, Complete, run by Gulf Medical University at 1 site in United Arab Emirates.
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 Sep 2026. 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 United Arab Emirates. 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?
Change in Peri-Implant Crestal Bone Height (time frame: Baseline (implant placement), 6 months, and 12 months). 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 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.