Comparison of Dental Implants with Different Surface Properties

NCT06508723 · tracked via the Priya Life Science Turkey tracker

Sponsor

Kutahya Health Sciences University

Phase

Not applicable

Started

2023-04-05

Last updated

2024-12-02

Condition(s) studied

Dental Implant FailedPeri-Implantitis

Investigational drug(s) / intervention(s)

Dental implant placement

Dental implant placement: 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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

99 Years

Healthy volunteers

Accepted

Inclusion Criteria: Please find below the revised text which is clearer and free of any spelling, grammar or punctuation errors: 1. The patient must be between the ages of 18 to 99 years. 2. The patient should not have any systemic diseases. 3. There must be a toothless area in either the mandibular or maxillary region. 4. There must be natural teeth present in the opposing arch. 5. The patient should be periodontally healthy. 6. There should not be any oral or mucosal diseases present. 7. There must be sufficient bone present for implant placement, with a diameter of at least 3.5 mm and a height of 8 mm. Exclusion Criteria: Please find below a list of factors that may affect dental treatment and require special consideration: 1. Patients who fall outside the specified age range. 2. Patients with systemic diseases. 3. Patients who have received radiotherapy to the head and neck region. 4. Patients who have bruxism habits. 5. Patients who smoke more than 10 cigarettes per day. 6. Patients who use drugs that suppress the immune system or impair healing, such as steroids or bisphosphonates. 7. Patients with alcohol and substance addiction. 8. Patients who do not comply with treatment. 9. Pregnant women and those who are breastfeeding. 10. Mentally retarded patients.

Primary outcome measure(s)

Peri-implant marginal bone loss — 1-year follow-up of all implants after prosthetic loading
The primary outcome was the assessment of marginal bone loss on radiographs at 1-year follow-up.

Trial sites (1)

Facility	City	Region	Status
Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology	Kütahya	Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06508723 on ClinicalTrials.gov ↗ ← All trials in Turkey