Edentulous MaxillaNCT01961284
Zygomatic Versus Conventional Dental Implants in Augmented Maxillae
A study testing Zygomatic implant placement and conventional implants and augmentation of maxilla in people with Edentulous Maxilla and Resorbed Maxilla, run by NHS Lothian at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Maxilla, Resorbed Maxilla, Implant Therapy
- What is being tested?
- Zygomatic implant placement and conventional implants and augmentation of maxilla
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2013to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- fully edentulous patients
- atrophic maxilla
- insufficient bone volume for placement of dental implants
- patients with no more than 4mm of bone height sub-antrally
Who cannot join
- general contraindications to implant surgery
- history of radiation therapy
- immunosuppressed/immunocompromised patients
- patients taking bisphosphonates
- poor oral hygiene
- patients with untreated periodontitis
Show all 11Show fewer
- uncontrolled diabetes
- pregnancy
- alcohol/drug addiction
- lack of opposite occluding dentition/prosthesis
- restricted mouth opening.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Glasgow Dental Hospital and School
Glasgow
St John's Hospital
Livingston
About this study
Official title: Zygomatic Versus Conventional Dental Implants in Augmented Maxillae: a Pragmatic Multicentre Randomised Clinical Trial.
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
- Being tested
- Zygomatic implant placement, conventional implants and augmentation of maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zygomatic implant placementDevice
conventional implants and augmentation of maxillaDevice
| Study group | Role | What they receive |
|---|---|---|
| Zygomatic Implants | Active comparator | 2-4 zygomatic implants inserted into edentulous maxilla with no augmentation/grafting prior to providing patient with dental prosthesis Receives: 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. Receives: Device: conventional implants and augmentation of maxilla |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant success
Implant failure is defined by implant mobility +/- infection dictating implant removal.
Measured: 1 year following implant loading
Implant success
Implant failure is defined by implant mobility +/- infection dictating implant removal
Measured: 3 years following implant loading
Implant success
Implant failure is defined by implant mobility +/- infection dictating implant removal.
Measured: 5 years after implant loading
Implant Success
Implant failure is defined by implant mobility +/- infection dictating implant removal
Measured: 7 years after implant loading
Implant Success
Implant failure is defined by implant mobility +/- infection dictating implant removal
Measured: 10 years after implant loading
Implant success
Implant failure is defined by implant mobility +/- infection dictating implant removal
Measured: 15 years after implant loading
Secondary outcomes (9)
Complications
Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis,abscess, fistula, gingival dehiscence.
Prosthetic complication: abutment fracture
Measured: 1 year
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.
Measured: 1,3,5,7,10,15 years
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.
Measured: 6 months after augmentation procedure
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.
Measured: 1,3,5,7,10,15
Complications
Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture
Measured: 3 years
Complications
Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture
Measured: 5 years
Complications
Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture
Measured: 7 years
Complications
Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture
Measured: 10 years
Complications
Biologic and prosthetic complications will be assessed. Biologic complications include perimplantitis, maxillary sinusitis, abscess, fistula, gingival dehiscence Prosthetic complication: abutment fracture
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: Sponsor company decision to terminate study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MaxillaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Collaborators
- NHS Greater Glasgow and Clyde
- Responsible party
- Principal investigator, Victor Lopes, NHS Lothian
- Investigators
- Victor Lopes, PhD, Study chair, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961284
- Sponsor's protocol ID
- 13/SS/0106
- Status last verified
- Sep 2017
- First submitted
- 4 Sep 2013
- Last updated
- 25 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zygomatic Versus Conventional Dental Implants in Augmented Maxillae: a Pragmatic Multicentre Randomised Clinical Trial.
- ClinicalTrials.gov ID
- NCT01961284
- Acronym / sponsor ID
- 13/SS/0106
- Conditions
- Edentulous Maxilla, Resorbed Maxilla, Implant Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor company decision to terminate study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Collaborators
- NHS Greater Glasgow and Clyde
- Study start
- Oct 2013
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zygomatic Implants | Active comparator | Device: Zygomatic implant placement2-4 zygomatic implants inserted into edentulous maxilla with no augmentation/grafting prior to providing patient with dental prosthesis |
| Bone Graft and Conventional implants | Active comparator | Device: conventional implants and augmentation of maxillaEdentulous 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- fully edentulous patients
- atrophic maxilla
- insufficient bone volume for placement of dental implants
- patients with no more than 4mm of bone height sub-antrally
Key exclusion criteria (11 listed)
- general contraindications to implant surgery
- history of radiation therapy
- immunosuppressed/immunocompromised patients
- patients taking bisphosphonates
- poor oral hygiene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zygomatic implant placement | Device | Zygomatic Implants |
| conventional implants and augmentation of maxilla | Device | Bone Graft and Conventional implants |
Primary outcome
Implant success
Time frame: 1 year following implant loading
Implant failure is defined by implant mobility +/- infection dictating implant removal.
Implant success
Time frame: 3 years following implant loading
Implant failure is defined by implant mobility +/- infection dictating implant removal
Implant success
Time frame: 5 years after implant loading
Implant failure is defined by implant mobility +/- infection dictating implant removal.
Implant Success
Time frame: 7 years after implant loading
Implant failure is defined by implant mobility +/- infection dictating implant removal
Implant Success
Time frame: 10 years after implant loading
Implant failure is defined by implant mobility +/- infection dictating implant removal
Implant success
Time frame: 15 years after implant loading
Implant failure is defined by implant mobility +/- infection dictating implant removal
9 secondary outcomes
Complications
Time frame: 1 year
Change in marginal bone levels on intra oral radiographs
Time frame: 1,3,5,7,10,15 years
Failure of augmentation procedure
Time frame: 6 months after augmentation procedure
Change in Oral Health impact profile OHIP-14
Time frame: 1,3,5,7,10,15
Complications
Time frame: 3 years
Complications
Time frame: 5 years
Complications
Time frame: 7 years
Complications
Time frame: 10 years
Complications
Time frame: 15 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
Related trials for Edentulous Maxilla
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Clinical and Radiographic Comparison of Two Implant-Abutment Connections
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Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
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Not yet recruitingEarly Phase 1
Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin
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Not yet recruiting
3D Metrology-Based Comparison of Functional Casts Made With Conventional and 3D-Printed Custom Trays
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Lopes, PhD study chair
NHS Lothian
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zygomatic implant placement and conventional implants and augmentation of maxilla in people with Edentulous Maxilla and Resorbed Maxilla, run by NHS Lothian at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant success (time frame: 1 year following implant loading). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.