Influence of Roxolid Implant Material on the Implant Stability Implant Stability

Completely Edentulous Patients Clinical Trial

— BLX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06334770
• Other study ID #: FDASuRecD032136
• Status: Completed
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: December 12, 2023

Study information

• Verified date: March 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 12, 2023
• Est. primary completion date: January 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Completely Edentulous Patients
• Mouth, Edentulous

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry of Dentistry Ainshams Univeristy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	secondary implant stability after 6 weeks	measuring secondary stability using ostell device and smart peg	6 weeks