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

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

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.

Study Overview

• Status: Completed
• Conditions: Completely Edentulous Patients
• Intervention / Treatment: Device: Roxolid implants; Device: Titanium implants

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry of Dentistry Ainshams Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: Straumann BLX® SLA implants
Active Comparator: 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.	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.; Other Names: JD EVOLUTION PLUS implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measuring primary at time of surgery	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.	same day of implant placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
secondary implant stability after 6 weeks	measuring secondary stability using ostell device and smart peg	6 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: shaimaa L mohamed, PROFESSOR, Ains hams univeristy

Publications and helpful links

General Publications

• Pandey C, Rokaya D, Bhattarai BP. Contemporary Concepts in Osseointegration of Dental Implants: A Review. Biomed Res Int. 2022 Jun 14;2022:6170452. doi: 10.1155/2022/6170452. eCollection 2022.
• Thanasrisuebwong P, Pimkhaokham A, Jirajariyavej B, Bencharit S. Influence of the Residual Ridge Widths and Implant Thread Designs on Implant Positioning Using Static Implant Guided Surgery. J Prosthodont. 2023 Apr;32(4):340-346. doi: 10.1111/jopr.13557. Epub 2022 Jun 22.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): January 22, 2022
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: FDASuRecD032136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: THE PROTOCOL OF OUR STUDY THAT WILL BE SHARED
• IPD Sharing Time Frame: The data is already available
• IPD Sharing Access Criteria: A link contains the pdf of the study protocol
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No