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Zygomatic Versus Conventional Dental Implants in Augmented Maxillae

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ClinicalTrials.gov Identifier: NCT01961284
Recruitment Status : Withdrawn (Sponsor company decision to terminate study)
First Posted : October 11, 2013
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Victor Lopes, NHS Lothian

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.

Condition or disease Intervention/treatment Phase
Edentulous Maxilla Resorbed Maxilla Implant Therapy Device: Zygomatic implant placement Device: conventional implants and augmentation of maxilla Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zygomatic Versus Conventional Dental Implants in Augmented Maxillae: a Pragmatic Multicentre Randomised Clinical Trial.
Study Start Date : October 2013
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Arm Intervention/treatment
Active Comparator: Zygomatic Implants
2-4 zygomatic implants inserted into edentulous maxilla with no augmentation/grafting prior to providing patient with dental prosthesis
Device: Zygomatic implant placement
Active Comparator: Bone Graft and Conventional implants
Edentulous maxilla which is deficient in bone is first grafted using bone grafting material derived from cows and then ordinary implants are placed into the augmented jaw bone approximately 6 monhts after grafting. Patients will be provided with a dental prosthesis following osseointegration.
Device: conventional implants and augmentation of maxilla



Primary Outcome Measures :
  1. Implant success [ Time Frame: 1 year following implant loading ]
    Implant failure is defined by implant mobility +/- infection dictating implant removal.

  2. Implant success [ Time Frame: 3 years following implant loading ]
    Implant failure is defined by implant mobility +/- infection dictating implant removal

  3. Implant success [ Time Frame: 5 years after implant loading ]
    Implant failure is defined by implant mobility +/- infection dictating implant removal.

  4. Implant Success [ Time Frame: 7 years after implant loading ]
    Implant failure is defined by implant mobility +/- infection dictating implant removal

  5. Implant Success [ Time Frame: 10 years after implant loading ]
    Implant failure is defined by implant mobility +/- infection dictating implant removal

  6. Implant success [ Time Frame: 15 years after implant loading ]
    Implant failure is defined by implant mobility +/- infection dictating implant removal


Secondary Outcome Measures :
  1. Complications [ Time Frame: 1 year ]

    Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis,abscess, fistula, gingival dehiscence.

    Prosthetic complication: abutment fracture


  2. Change in marginal bone levels on intra oral radiographs [ Time Frame: 1,3,5,7,10,15 years ]
    To be evaluated on intraoral radiographs taken with the paralleling technique at implant placement, at delivery of the provisional prostheses, 1, 3, 5, 7, 10 and 15 years after loading.

  3. Failure of augmentation procedure [ Time Frame: 6 months after augmentation procedure ]
    The augmentation procedure will be considered a failure if, after it has been performed, it will not be possible to place the planned implants in the augmented site.

  4. Change in Oral Health impact profile OHIP-14 [ Time Frame: 1,3,5,7,10,15 ]
    To be filled in i)at patient enrolment prior to delivering any interventions, ii)12 weeks after delivery of the definitive prostheses and iii) 1, 3, 5, 7, 10 and 15 years after loading. Patients' number of days with total or partial impaired activity assessed at delivery of the provisional prosthesis A days of total impaired activity is one where patient is unable to perform his/her ordinary life activity including work. A days of partial impaired activity is one where the patient is only partially able to perform his/her ordinary life activity including work.

  5. Complications [ Time Frame: 3 years ]
    Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture

  6. Complications [ Time Frame: 5 years ]
    Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture

  7. Complications [ Time Frame: 7 years ]
    Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture

  8. Complications [ Time Frame: 10 years ]
    Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture

  9. Complications [ Time Frame: 15 years ]
    Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • restricted mouth opening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961284


Locations
United Kingdom
Glasgow Dental Hospital and School
Glasgow, United Kingdom
St John's Hospital
Livingston, United Kingdom
Sponsors and Collaborators
NHS Lothian
NHS Greater Glasgow and Clyde
Investigators
Study Chair: Victor Lopes, PhD NHS Lothian

Responsible Party: Victor Lopes, Professor Victor Lopes, Consultant in Oral and Maxillofacial surgery, NHS Lothian
ClinicalTrials.gov Identifier: NCT01961284     History of Changes
Other Study ID Numbers: 13/SS/0106
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017