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Influence of Roxolid Implant Material on the Implant Stability Implant Stability

Influence of Roxolid Implant Material on the Implant Stability of Maxillary Implant Retained Overdenture

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06334770
Acronym
BLX
Enrollment
18
Registered
2024-03-28
Start date
2021-06-15
Completion date
2023-12-12
Last updated
2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Completely Edentulous Patients

Brief summary

Fourteen completely edentulous patients were selected to participate in this study. From the outpatient clinic of Prosthodontic Department, Faculty of Dentistry, Ain Shams University. After fabrication of complete denture for all patients, patients were randomly divided to: Group A: Seven patients were rehabilitated with implant retained maxillary overdenture where four Straumann BLX® implant were inserted opposed by mandibular complete denture. Group B: Seven patients were rehabilitated with implant retained maxillary overdenture where four conventional acid etched implants were inserted opposed by mandibular complete denture. After implant placement using surgical guide, smart peg and ostell device were used to measure the primary stability of the implant then cover screw was placed and after six weeks, secondary stability was measured for both groups. After four months, the second stage started in which exposure of the implant fixtures took place and pick up was carried out. Patients were recalled frequently for post-insertion inspection and adjustment.

Detailed description

Background: long term success of implant restoration depends on many factors one of them is the sufficient implant stability which is lowered in compromised bone density sites such as the maxilla which is categorized as type III & IV bone, so searching for new innovation and updates in implant material and features is very mandatory. So, the aim of this study was asses and compare between two implant materials roxolid versus traditional titanium on the primary and secondary stability. Methods: eighteen completely edentulous patients were selected they all received maxillary implant retained overdentures and lower complete dentures, they were divided equally in to two groups according to the type of the material of the implants. Group A received a total number of 36 (Roxolid) Implants were made of roxolid material and Group B received a total number 36 (Titanium) implants were made of traditional titanium alloys. Implant stability was assed using ostell device, the primary implant stability was measured at the day of implant installation however, secondary implant stability was measured after six weeks of implant placement. Paired t-test was used to compare between primary and secondary stability in the same group and independent t-test was used to compare between the two groups with a significant level \< 0.05.

Interventions

DEVICERoxolid implants

four Straumann BLX® roxolid implant 15% zirconium and 85% titanium), 3.7 mm in diameter, and 10 mm in length.implants were selected with the following criteria: tapered, self-tapping, aggressively threaded,were inserted with novalock attachments.

DEVICETitanium implants

four conventional acid etched pure implants tapered, self-tapping, threaded, two-piece, with the 10 mm length and 3.7 mm diameter were inserted with Sphero flex attachments.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Completely edentulous patients as the last extraction should be at least six months before implant placement. * Patients with good oral hygiene. * Sufficient inter arch space (11 mm) which were diagnosed by mounted diagnostic casts. * Firm and healthy mucosa covering the residual alveolar ridge.

Exclusion criteria

* \- Heavy smokers. * Patients with para functional habits. * Patients had TMJ disorders. * Patients had systemic disease that could interfere with implant placement or affect bone healing such as; thyroid and uncontrolled diabetes. * Patients undergoing chemo and radiotherapy.

Design outcomes

Primary

MeasureTime frameDescription
measuring primary at time of surgerysame day of implant placementusing an Ostell device with a smart peg to measure primary stability at the time of implant placement and measuring secondary stability after six weeks of implant placement.

Secondary

MeasureTime frameDescription
secondary implant stability after 6 weeks6 weeksmeasuring secondary stability using ostell device and smart peg

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026