Comparison of Dental Implants with Different Surface Properties

NCT06508723 | Enrolling By Invitation

• 1 other identifier: 2023-03/04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This controlled, parallel clinical study aims to compare the effect of fixed prosthetic restorations placed in the posterior region with different implant surfaces on clinical and peri-implant marginal bone loss. The main question(s) it aims to answer are: Is there a difference between peri-implant marginal bone loss levels in dental implants with two different surfaces placed in the posterior region? Is there a difference in peri-implant clinical parameters in dental implants with two different surfaces placed in the posterior region? The study includes a test group (implant with Ti-Ulta surface) and a control group (implant with Ti-Unite surface). Two implants with different surfaces will be placed in the bone following the same routine implant placement protocol.

Conditions

Dental Implant Failed; Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• Peri-implant marginal bone loss

  The primary outcome was the assessment of marginal bone loss on radiographs at 1-year follow-up.

  1-year follow-up of all implants after prosthetic loading

Study Arms (2)

Test Group

OTHER

The group in which implants with a Ti-Ultra surface are placed.

Procedure: Dental implant placement

Control Group

OTHER

The group in which implants with a Ti-Unite surface are placed.

Procedure: Dental implant placement

Interventions

Dental implant placement PROCEDURE

The same routine implant placement protocol will be applied to both study groups with different surfaces and will be placed in the bone. After local anesthesia, a full-thickness flap will be raised. The implant socket will be created according to the protocol recommended by the company and all implants will be placed in the socket with a torque force of 35 N and the implants will be placed. Once bleeding control is achieved, the flap will be closed primarily. Healing caps will be installed after 3 months. After waiting for wound healing, prosthetic restoration will be performed.

Control Group; Test Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Please find below the revised text which is clearer and free of any spelling, grammar or punctuation errors:
• The patient must be between the ages of 18 to 99 years.
• The patient should not have any systemic diseases.
• There must be a toothless area in either the mandibular or maxillary region.
• There must be natural teeth present in the opposing arch.
• The patient should be periodontally healthy.
• There should not be any oral or mucosal diseases present.
• There must be sufficient bone present for implant placement, with a diameter of at least 3.5 mm and a height of 8 mm.

You may not qualify if:

• Please find below a list of factors that may affect dental treatment and require special consideration:
• Patients who fall outside the specified age range.
• Patients with systemic diseases.
• Patients who have received radiotherapy to the head and neck region.
• Patients who have bruxism habits.
• Patients who smoke more than 10 cigarettes per day.
• Patients who use drugs that suppress the immune system or impair healing, such as steroids or bisphosphonates.
• Patients with alcohol and substance addiction.
• Patients who do not comply with treatment.
• Pregnant women and those who are breastfeeding.
• Mentally retarded patients.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Berceste Guler Ayyildiz

  Kutahya Health Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc.prof.dr.

Model Details: randomized, controlled, prospective

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 18, 2024
• Study Start: April 5, 2023
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months after the study is completed and published
• Access Criteria: If contacted, the principal researcher's evaluation will be shared.

Locations

TU (1)