RecruitingACTRN12619000259145

Randomised controlled trial of the effect of different dental implant collar designs on the oral tissue response.

Clinical, microbial, and radiographic evaluation of dental implants with laser microgrooved collars with and without a platform-switched design: a randomised controlled clinical trial


Sponsor

Griffith University

Enrollment

20 participants

Start Date

Mar 1, 2019

Study Type

Interventional

Conditions

Summary

This trial aims to explore the clinical outcomes of commonly used dental implant designs on the market. The tissue stability around dental implants is associated with aesthetic and biological success. Both designs have independent evidence suggesting the potential to increase tissue stability. Patients from the Griffith University Dental School requiring two implants fulfilling criteria will be offered inclusion in the study. The study will involve monitoring routine parameters during associated procedures and recalls; along with the addition of a one off non-invasive dental plaque sample. It is expected that both implant designs will show at least equal results to industry standards if not benefits. Although, there is limited data directly comparing these designs in the literature, this study aims to reduce that void.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Dental implants are a common and effective solution for replacing missing teeth, but the long-term success of an implant depends heavily on how well the surrounding gum and bone tissue remains stable and healthy over time. Different implant designs — particularly around the collar or neck of the implant where it meets the gum — may influence how well that tissue is maintained. This trial is comparing two commonly used dental implant collar designs to see which one better supports the health of surrounding tissues. Patients needing two implants at Griffith University Dental School will receive one implant of each design, allowing a direct comparison within the same person. Routine check-ups and a one-off non-invasive plaque sample will be used to track tissue health over time. You may be eligible if you need two dental implants, have sufficient bone and gum tissue in good condition, are over 18 years old, and maintain reasonable oral hygiene. People with untreated gum disease, systemic illnesses that affect healing, pregnancy, or poor oral hygiene would generally not qualify.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients requiring 2 simple dental implants. At placement the implant collar design will be randomly allocated: "BioHorizons internal tapered" or "BioHorizons internal tapered plus". Both implants h

Patients requiring 2 simple dental implants. At placement the implant collar design will be randomly allocated: "BioHorizons internal tapered" or "BioHorizons internal tapered plus". Both implants have a laser microgrooved collar, that is 12 and 8 µm grooves on the coronal ~1-2 mm of the implant body. The "internal tapered plus" has a platform switched design between the abutment and implant in addition to the laser microgrooves. One of each will be placed in each patient. The implants are then placed according to routine protocols by periodontics registrars, who are fully qualified general dentists, with a minimum of 1 years post-graduate training already completed. These implants are placed during the same procedure. These procedures being un-altered from routine implant placement should take the average required time of 1-2 hours. These procedures, and adherence to intervention fidelity will be overseen and confirmed by the head of the discipline in Periodontics and Implantology.


Locations(1)

Griffith University Clinical Trials Unit - Southport

QLD, Australia

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ACTRN12619000259145


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