Influence of Roxolid Implant Material on the Implant Stability Implant Stability

NCT06334770 | Completed

• 1 other identifier: FDASuRecD032136
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Completely Edentulous Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• secondary implant stability after 6 weeks

  6 weeks

Study Arms (2)

Group( A) ROXOLID IMPLANT

EXPERIMENTAL

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

Group (B) CONVENTIONAL TITANIUM IMPLANT

ACTIVE COMPARATOR

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

Device: Titanium implants

Interventions

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.

Also known as: Straumann BLX® SLA implants

Group( A) ROXOLID IMPLANT

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.

Also known as: JD EVOLUTION PLUS implants

Group (B) CONVENTIONAL TITANIUM IMPLANT

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry of Dentistry Ainshams Univeristy

Cairo, Egypt

Location

Related Publications (3)

• 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.

  PMID: 35747499 BACKGROUND

• 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.

  PMID: 35686699 BACKGROUND

• El-Hady AIA, Eid HI, Mohamed SL, Fadl SM. Influence of titanium and titanium-zirconium alloy as implant materials on implant stability of maxillary implant retained overdenture: a randomized clinical trial. BMC Oral Health. 2024 Aug 6;24(1):902. doi: 10.1186/s12903-024-04692-x.

  PMID: 39107737 DERIVED

Study Officials

• shaimaa L mohamed, PROFESSOR

  Ains hams univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 28, 2024
• Study Start: June 15, 2021
• Primary Completion: January 22, 2022
• Study Completion: December 12, 2023
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data is already available
• Access Criteria: A link contains the pdf of the study protocol

Locations

EG (1)