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OpenTrials
Completed

NCT Number: NCT07824219

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

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.

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Key information

Conditions

Jaw, Edentulous Edentulism, Complete Jaw Diseases Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Peri-implant Bone Loss Stomatognathic Diseases Tooth Diseases

Age range

45 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Gulf Medical University

Ajman, United Arab Emirates

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 informed consent.

Exclusion criteria

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

Treatment and study plan

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.

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

Sponsors and collaborators

Lead sponsor

Gulf Medical University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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