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Clinical Trials/NCT01961284
NCT01961284
Withdrawn
N/A

Zygomatic Versus Conventional Dental Implants in Augmented Maxillae: a Pragmatic Multicentre Randomised Clinical Trial.

NHS Lothian2 sites in 1 countryOctober 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Edentulous Maxilla
Sponsor
NHS Lothian
Locations
2
Primary Endpoint
Implant Success
Status
Withdrawn
Last Updated
8 years ago

Overview

Brief Summary

Dental implants are used for replacing missing teeth. Placing dental implants is limited by the presence of adequate bone volume permitting their anchorage. In order to solve this problem several bone augmentation procedures have been developed. In principle the missing bone is taken from a donor site (for example the hip), transplanted where needed and then implants are placed. Sometimes, major bone grafting operations have to be undertaken under general anaesthesia requiring patients to be hospitalised for a few days. Some degree of morbidity related to the donor site must be expected, though more recently bone substitutes are used to minimize morbidity, and 2 to 3 surgical interventions may be needed before the implants can be functionally used. Sometimes patients have to wait more than 1 year before a prosthesis can be fixed to the implants and the total cost of the treatment is high. At the beginning of the 1990s a long screwshaped implant was developed by Professor PI Brånemark as an alternative to bone augmentation procedures: the zygomatic implant. Zygomatic implants are generally inserted through the palate to engage the body of the cheek bone. One to three zygomatic implants can be inserted through the posterior palate to engage the body of each cheek bone. The potential main advantages of zygomatic implants could be that bone grafting may not be needed and a fixed prosthesis could be fitted the same day of their placement. Despite that zygomatic implants have been used for more than 20 years, their effectiveness has never been compared with conventional dental implants in augmented maxillae. The aim of the project is to compare the longtermclinical outcome of fullarch upper jaw bridges supported by zygomatic implants versus conventional implants placed in augmented bone in the palate.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
August 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Victor Lopes

Professor Victor Lopes, Consultant in Oral and Maxillofacial surgery

NHS Lothian

Eligibility Criteria

Inclusion Criteria

  • fully edentulous patients
  • atrophic maxilla
  • insufficient bone volume for placement of dental implants
  • patients with no more than 4mm of bone height sub-antrally

Exclusion Criteria

  • general contraindications to implant surgery
  • history of radiation therapy
  • immunosuppressed/immunocompromised patients
  • patients taking bisphosphonates
  • poor oral hygiene
  • patients with untreated periodontitis
  • uncontrolled diabetes
  • pregnancy
  • alcohol/drug addiction
  • lack of opposite occluding dentition/prosthesis

Outcomes

Primary Outcomes

Implant Success

Time Frame: 10 years after implant loading

Implant failure is defined by implant mobility +/- infection dictating implant removal

Implant success

Time Frame: 15 years after implant loading

Implant failure is defined by implant mobility +/- infection dictating implant removal

Secondary Outcomes

  • Change in marginal bone levels on intra oral radiographs(1,3,5,7,10,15 years)
  • Complications(15 years)
  • Failure of augmentation procedure(6 months after augmentation procedure)
  • Change in Oral Health impact profile OHIP-14(1,3,5,7,10,15)

Study Sites (2)

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