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CompletedNCT07824219Updated Sep 17, 2026

Tri-Lobe vs. Hexagonal Connections in Immediately Loaded Mandibular Overdentures

An interventional study of ReActive Implant System (Internal Tri-Lobe Platform) and Legacy II Implant System (Internal Hexagonal Platform) in Jaw, Edentulous, Edentulism, Complete and Peri-implant Bone Loss, sponsored by Gulf Medical University. Completed at 1 site in United Arab Emirates. Open to male participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Gulf Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Dec 2024, registered Sep 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
45 Years to 60 Years
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Jaw, Edentulous
  • Edentulism, Complete
  • Peri-implant Bone Loss

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03

In context

Jaw, Edentulous

122 studies on the registry are indexed under Jaw, Edentulous; 20 are open to participants now.

This study's enrollment of 14 is below the median of 24 across 99 interventional studies indexed under Jaw, Edentulous.

Browse Jaw, Edentulous studies →

Lead sponsor

Gulf Medical University is the lead sponsor of 43 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • Systemic conditions affecting bone metabolism; heavy smoking; poorly controlled diabetes; history of radiotherapy or chemotherapy.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Internal Tri-Lobe Connection

    Patients fitted with the ReActive Implant System (internal tri-lobe platform).

    Device: ReActive Implant System (Internal Tri-Lobe Platform)

  • Active comparator
    Internal Hexagonal Connection

    Patients fitted with the Legacy II Implant System (internal hexagonal platform).

    Device: Legacy II Implant System (Internal Hexagonal Platform)

Interventions

  • DeviceReActive 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.

  • DeviceLegacy 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.

06

What researchers measure

Primary outcomes

  1. Change in Peri-Implant Crestal Bone Height

    Time frame: Baseline (implant placement), 6 months, and 12 months

Secondary outcomes

  1. Change in Peri-Implant Bone Density

    Time frame: Baseline (implant placement), 6 months, and 12 months

07

Study locations

1 site
  • Gulf Medical University
    Ajman, United Arab Emirates
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2024 to primary completion in May 2026, 17 months.

Of 58 non-industry interventional studies with no phase under Jaw, Edentulous, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's 17 months is close to that.

Counting every sponsor, half of 66 studies reached it within 20 months; a quarter within 12 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2026
First posted
Sep 17, 2026
StartActual
Dec 1, 2024
Primary completionActual
May 1, 2026
CompletionActual
May 1, 2026
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07824219
Lead sponsor
Gulf Medical University
Responsible party
Rania Zaarour (Dr, Gulf Medical University) — Principal investigator
First posted
Sep 17, 2026
Start date
Dec 1, 2024
Primary completion
May 1, 2026
Completion
May 1, 2026
Last update
Sep 17, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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