Zygomatic Versus Conventional Dental Implants in Augmented Maxillae

Edentulous Maxilla Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01961284
• Other study ID #: 13/SS/0106
• Status: Withdrawn
• Phase: N/A
• First received: September 4, 2013
• Last updated: September 20, 2017
• Start date: October 2013
• Est. completion date: August 2017

Study information

• Verified date: September 2017
• Source: NHS Lothian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edentulous Maxilla
• Implant Therapy
• Resorbed Maxilla

Intervention

Device:
• Zygomatic implant placement

• conventional implants and augmentation of maxilla

Locations

Country	Name	City	State
United Kingdom	Glasgow Dental Hospital and School	Glasgow
United Kingdom	St John's Hospital	Livingston

Sponsors (2)

Lead Sponsor	Collaborator
NHS Lothian	NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant success	Implant failure is defined by implant mobility +/- infection dictating implant removal.	1 year following implant loading
Primary	Implant success	Implant failure is defined by implant mobility +/- infection dictating implant removal	3 years following implant loading
Primary	Implant success	Implant failure is defined by implant mobility +/- infection dictating implant removal.	5 years after implant loading
Primary	Implant Success	Implant failure is defined by implant mobility +/- infection dictating implant removal	7 years after implant loading
Primary	Implant Success	Implant failure is defined by implant mobility +/- infection dictating implant removal	10 years after implant loading
Primary	Implant success	Implant failure is defined by implant mobility +/- infection dictating implant removal	15 years after implant loading
Secondary	Complications	Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis,abscess, fistula, gingival dehiscence.; Prosthetic complication: abutment fracture	1 year
Secondary	Change in marginal bone levels on intra oral radiographs	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.	1,3,5,7,10,15 years
Secondary	Failure of 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.	6 months after augmentation procedure
Secondary	Change in Oral Health impact profile OHIP-14	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.	1,3,5,7,10,15
Secondary	Complications	Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture	3 years
Secondary	Complications	Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture	5 years
Secondary	Complications	Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture	7 years
Secondary	Complications	Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture	10 years
Secondary	Complications	Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture	15 years