RecruitingACTRN12625000989448

A randomised controlled trial comparing effectiveness of rough and smooth dental implants on jaw function after jaw reconstruction for cancer.

A randomised controlled trial comparing effectiveness of rough and smooth dental implants on jaw function after jaw reconstruction for cancer patients.


Sponsor

Chris O'Brien Lifehouse

Enrollment

104 participants

Start Date

Jun 1, 2026

Study Type

Interventional

Conditions

Summary

The purpose of this project is to determine the effectiveness of two types of dental implants. We have two types of dental implants that are used routinely. The two types of dental implants differ in the amount of smooth area. The research project is testing which type of dental implant is better to keep the bone and soft tissue around the dental implants healthy so the dental implants can survive for a long time. Who is it for? You may be eligible to join this study if you are aged 18 years and older, have head and neck cancer and will undergo Osseous free flap reconstruction of the jaw requiring dental rehabilitation with endosteal dental implants. Study Details: You will receive both types of dental implants (if you need more than one dental implant). Your dental implants will be randomly chosen for implant location in your mouth and type at each location. You will have head and neck reconstructive surgery as planned and dental implants will be placed. Following your surgery, bone loss and soft tissue assessments will be conducted every 3 months for 1 year after your operation as routine standard of care. However, these appointments are longer to assess bone loss (15 to 30 minutes) and soft tissue health (15 to 30 minutes) around dental implants for trial purpose. Quality-of-life patient reported data will also be collected using the FACE-Q Head and Neck Module questionnaire and the European Quality of Life-5 Dimensions (EQ-5D-5L) at the first appointment and 3,6,9,12 months post-op. Participation in this clinical trial is voluntary. It is hoped this research will generate new information about dental implants and therefore improve the outcomes of future patients undergoing head and neck reconstructive surgery.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • All cases will be discussed at MDT and deemed appropriate for the protocol within that setting. Osseous free flap reconstruction of the jaw requiring dental rehabilitation with endosteal dental implants.

Exclusion Criteria2

  • Inability to give informed consent
  • < 18 years of age.

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Interventions

Primary objective is to compare bone loss around a standard dental implant (IBNT) (control) and a smooth-cuffed dental implant (MSC-IBNT) (intervention) placed in patients undergoing jaw reconstructio

Primary objective is to compare bone loss around a standard dental implant (IBNT) (control) and a smooth-cuffed dental implant (MSC-IBNT) (intervention) placed in patients undergoing jaw reconstruction using osseous free flaps. Both implants are used in routine clinical dentistry, however, this study will focus on patients undergoing reconstruction of the oral cavity for cancer where it is unknown which type of implant is associated with longer implant survival The Intervention: MSC-IBNT are dental implants that have a smooth cuff just below the collar near the emergence of the implant from the bone. MSC-IBNT refers to a specific dental implant system that features the Machined Surface Coronal (MSC) hybrid design and incorporates "Innovative Narrow Body Tapered" (IBNT) features. This design combines a smooth coronal surface to resist bacterial adhesion and a moderately rough surface for superior osseointegration. How the MSC-IBNT is applied: The implant site (osteotomy) will be prepared in the fibula following a standardised protocol. The IBNT and MSC-IBNT implants will be placed in the same manner but alternating. Note: This intervention does not differ from the standard of care. 1. Point drill 2. 2.2 mL Tru Guide drill to 2mm beyond desired implant length (stop short of being beyond inferior cortex) 3. Using drill extension, use 2.9mm parallel drill to previous osteotomy length 4. Using IBNT tap to desired implant length 5. Use 3mm round bur to reduce bone to facilitate full seating of the implant and space for components to be secured to the implant without bony interferences. 6. Implant placement and aim for insertion torque of 40 Ncm 7. Check for the need for further crestal bone reduction if required The surgeon will complete an IMPLANT PLACEMENT PROFORMA to record compliance with the protocol. Approximate duration of the surgery: The Head and Neck reconstruction surgery with dental implants can take between 6-10 hours (standard of care) Interventions include: Participants will receive both types of dental implants (if requiring more than one dental implant). The dental implants will be randomly chosen for implant location in your mouth and type at each location. Preoperative appointment with your surgeon for reconstructive surgery, participants will answer a quality-of-life questionnaire, which will take approximately 10 – 15 minutes. The head and neck reconstructive surgery is planned and dental implants will be placed. Following your surgery, bone loss and soft tissue assessments will be conducted every 3 months for 1 year after your operation as routine standard of care. However, these appointments are longer to assess bone loss (15 to 30 minutes) and soft tissue health (15 to 30 minutes) around dental implants for trial purpose. Participants will also complete a quality-of-life questionnaire (10 – 15 minutes) at each of the follow up appointments.


Locations(1)

Chris O’Brien Lifehouse - Camperdown

NSW, Australia

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ACTRN12625000989448


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