Influence of Roxolid Implant Material on the Implant Stability Implant Stability (BLX)

Ain Shams University

Status: Completed

Conditions: Completely Edentulous Patients

Treatments: Device: Roxolid implants; Device: Titanium implants

Study type: Interventional

Funder types: Other

Identifiers

NCT06334770

FDASuRecD032136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Group( A) ROXOLID IMPLANT

Experimental group

Description:

NINE patients were rehabilitated with implant retained maxillary overdenture where four Straumann BLX® ROXOLID implant were inserted opposed by mandibular complete denture.

Treatment:

Device: Roxolid implants

Group (B) CONVENTIONAL TITANIUM IMPLANT

Active Comparator group

Description:

NINE patients were rehabilitated with implant retained maxillary overdenture where four conventional titanium implants were inserted opposed by mandibular complete denture.

Treatment:

Device: Titanium implants