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COMPLETED
NCT07824219
NA

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

Sponsor: Gulf Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

45 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2024-12-01

Completion Date

2026-05-01

Last Updated

2026-09-17

Healthy Volunteers

Yes

Interventions

DEVICE

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

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.

Locations (1)

Gulf Medical University

Ajman, United Arab Emirates