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Completed

NCT Number: NCT06334770

Influence of Roxolid Implant Material on the Implant Stability Implant Stability

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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Key information

Conditions

Completely Edentulous Patients

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry of Dentistry Ainshams Univeristy

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Roxolid implants

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.

Other names: Straumann BLX® SLA implants

Titanium implants

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.

Other names: JD EVOLUTION PLUS implants

Primary outcomes

  1. measuring primary at time of surgery

    Time frame: same day of implant placement

    using 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 outcomes

  1. secondary implant stability after 6 weeks

    Time frame: 6 weeks

    measuring secondary stability using ostell device and smart peg

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: BLX

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 28, 2024
Registry last updated
Mar 28, 2024

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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