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A simplified method for extracortical alveolar bone regeneration for dental implant placement in a private practice setting with up to 10 years follow up: A prospective case series study.

A simplified method for extracortical alveolar bone regeneration for dental implant placement in a private practice setting with up to 10 years follow up: A prospective case series study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12626001071314
Enrollment
25
Registered
2026-08-31
Start date
2021-02-23
Completion date
2023-10-20
Last updated
2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to assess the amount of new bone volume that can be achieved using an established surgical technique know as guided bone regeneration (GBR). The regenerated bone will be used for the purpose of replacing missing teeth with dental implants. The study will be performed at a private specialist periodontal practice. In addition to assessing the volume of newly created bone, potential side effects such as swelling, pain and gum infection around the dental implants will be assessed for a period of up to 10 years from the GBR procedure.

Interventions

An existing surgical technique known as guided bone regeneration (GBR) will be observed in a case series study involving 20-30 patients. GBR is used routinely in dentistry to regenerate bone for prosthetic tooth replacement with dental implants placement where teeth are missing. The amount of regenerated bone will be assessed 6 months after the GBR procedure. Implants placed within the regenerated bone will be assessed annually for up to 10 years following the GBR procedure. Participants will r

An existing surgical technique known as guided bone regeneration (GBR) will be observed in a case series study involving 20-30 patients. GBR is used routinely in dentistry to regenerate bone for prosthetic tooth replacement with dental implants placement where teeth are missing. The amount of regenerated bone will be assessed 6 months after the GBR procedure. Implants placed within the regenerated bone will be assessed annually for up to 10 years following the GBR procedure. Participants will recruited from patients referred to the principal investigator's specialist practice (referred from general dental practitioners). These patients are referred for implant procedures and GBR procedures if required. If these participants don't meet the selection criteria, they will still receive implant treatment or GBR treatment as per the usual standard of care for patients referred to the practice. The method used to assess the amount of regenerated bone will using conventional low dose CTs pre-GBR, 2 months and 5 months after the GBR procedure as per the standard to clinical care for GBR procedures. Participants will be asked to complete 10 specific questions related to the study (Patient-reported outcome measures or PROM's). The questions relate to pain perception 3 days and 10 days following the GBR procedure. In addition 8 questions, 12 months following restoration of the dental implants will need also be recorded. The method of measurement will be via a visual analogue scale (VAS) on a line graded 0-100. The surveys will be completed at the practices at follow-up visits. At the follow-up visits, a number other clinical parameters will be recorded related to the surgical and restorative procedures performed and which occurs at routine follow-up visits as per the routine standard of care. Other than the PROM questionaire, all treatment provided including follow-up visits will be as per the current standard or care for GBR and implant surgery at specialist dental practices. The time to take the surveys are expected to be approximately 5 months.

Sponsors

Prof Dax Calder, specialist periodontist, West Perth Periodontics
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients attending a private specialist periodontal practice with a missing tooth or teeth referred by general dentists for surgical implant placement and bone regenerative procedures.

Exclusion criteria

• For systemic diseases, American Academy of Anaesthetists (ASA) Classification > 3. • Uncontrolled diabetes • Smoking > 10 cigs/day, uncontrolled diabetes, steroids medications, immunocompromised, undergoing cancer therapy, taking bisphosphonate medications. • Mucosal disease at the alveolar bone regeneration (ABR) sites under investigation. • Poor recall compliance • Active periodontitis associated with the residual dentition (pocket probing depths of > 5mm with bleeding on probing).

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026