MedDataX Logo

Zygomatic Versus Conventional Dental Implants in Augmented Maxillae

NCT ID: NCT01961284

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Edentulous Maxilla Resorbed Maxilla Implant Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Zygomatic Implants

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

Group Type ACTIVE_COMPARATOR

Zygomatic implant placement

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

conventional implants and augmentation of maxilla

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zygomatic implant placement

Intervention Type DEVICE

conventional implants and augmentation of maxilla

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role collaborator

NHS Lothian

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Victor Lopes

Professor Victor Lopes, Consultant in Oral and Maxillofacial surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Victor Lopes, PhD

Role: STUDY_CHAIR

NHS Lothian

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Glasgow Dental Hospital and School

Glasgow, , United Kingdom

Site Status

St John's Hospital

Livingston, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13/SS/0106

Identifier Type: -

Identifier Source: org_study_id