Edentulism, Complete, Jaw, Edentulous, Peri-implant Bone Loss
Conditions
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.
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.
Sponsors
Gulf Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Peri-Implant Crestal Bone Height | Baseline (implant placement), 6 months, and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in Peri-Implant Bone Density | Baseline (implant placement), 6 months, and 12 months |
Countries
United Arab Emirates
Outcome results
None listed