Zygomatic Versus Conventional Dental Implants in Augmented Maxillae

Not Applicable

Withdrawn

• Conditions: Resorbed Maxilla; Implant Therapy; Edentulous Maxilla
• Interventions: Device: Zygomatic implant placement; Device: conventional implants and augmentation of maxilla

• Registration Number: NCT01961284
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-04
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-11
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-20
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zygomatic Implants	Zygomatic implant placement	2-4 zygomatic implants inserted into edentulous maxilla with no augmentation/grafting prior to providing patient with dental prosthesis
Bone Graft and Conventional implants	conventional implants and augmentation of maxilla	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.

Primary Outcome Measures

Name	Time	Method
Implant Success	10 years after implant loading	Implant failure is defined by implant mobility +/- infection dictating implant removal
Implant success	15 years after implant loading	Implant failure is defined by implant mobility +/- infection dictating implant removal

Secondary Outcome Measures

Name	Time	Method
Change in marginal bone levels on intra oral radiographs	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.
Complications	15 years	Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture
Failure of augmentation procedure	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.
Change in Oral Health impact profile OHIP-14	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.

Trial Locations

Locations (2)

Glasgow Dental Hospital and School; 🇬🇧 Glasgow, United Kingdom

St John's Hospital; 🇬🇧 Livingston, United Kingdom