Influence of Roxolid Implant Material on the Implant Stability Implant Stability

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2023-12-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Completely Edentulous Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group( A) ROXOLID IMPLANT

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

Group Type EXPERIMENTAL

Roxolid implants

Intervention Type DEVICE

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.

Group (B) CONVENTIONAL TITANIUM IMPLANT

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

Group Type ACTIVE_COMPARATOR

Titanium implants

Intervention Type DEVICE

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.

Interventions

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Roxolid 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.

Intervention Type DEVICE

Titanium 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.

Intervention Type DEVICE

Other Intervention Names

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Straumann BLX® SLA implants JD EVOLUTION PLUS implants

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes