Zygomatic Versus Conventional Dental Implants in Augmented Maxillae

NCT01961284 | Withdrawn

• 1 other identifier: 13/SS/0106
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Edentulous Maxilla; Resorbed Maxilla; Implant Therapy

Outcome Measures

Primary Outcomes (6)

• Implant success

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

  1 year following implant loading

• Implant success

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

  3 years following implant loading

• Implant success

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

  5 years after implant loading

• Implant Success

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

  7 years after implant loading

• Implant Success

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

  10 years after implant loading

• Implant success

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

  15 years after implant loading

Secondary Outcomes (9)

• Complications

  1 year

• Change in marginal bone levels on intra oral radiographs

  1,3,5,7,10,15 years

• Failure of augmentation procedure

  6 months after augmentation procedure

• Change in Oral Health impact profile OHIP-14

  1,3,5,7,10,15

• Complications

  3 years

Study Arms (2)

Zygomatic Implants

ACTIVE COMPARATOR

2-4 zygomatic implants inserted into edentulous maxilla with no augmentation/grafting prior to providing patient with dental prosthesis

Device: Zygomatic implant placement

Bone Graft and Conventional implants

ACTIVE COMPARATOR

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

Interventions

Zygomatic implant placement DEVICE

Zygomatic Implants

conventional implants and augmentation of maxilla DEVICE

Bone Graft and Conventional implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Lothian: lead
• NHS Greater Glasgow and Clyde: collaborator

Study Sites (2)

Glasgow Dental Hospital and School

Glasgow, United Kingdom

Location

St John's Hospital

Livingston, United Kingdom

Location

Study Officials

• Victor Lopes, PhD

  NHS Lothian

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Victor Lopes, Consultant in Oral and Maxillofacial surgery

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: October 11, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

GB (2)