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

NCT07824219 | Completed

• 1 other identifier: 24-08/2
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Peri-Implant Crestal Bone Height

  Baseline (implant placement), 6 months, and 12 months

Secondary Outcomes (1)

• Change in Peri-Implant Bone Density

  Baseline (implant placement), 6 months, and 12 months

Study Arms (2)

Internal Tri-Lobe Connection

EXPERIMENTAL

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

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

Internal Hexagonal Connection

ACTIVE COMPARATOR

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

Device: Legacy II Implant System (Internal Hexagonal Platform)

Interventions

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.

Internal Tri-Lobe Connection

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.

Internal Hexagonal Connection

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Systemic conditions affecting bone metabolism; heavy smoking; poorly controlled diabetes; history of radiotherapy or chemotherapy.

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (1)

Gulf Medical University

Ajman, United Arab Emirates

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: December 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

AE (1)