Edentulous MaxillaNCT02405169
4 vs 6 Implants in Totally Edentulous Patient in Maxilla With Ti. Cad-cam Framework
A study testing 4 vs 6 implant treatment in the maxilla in people with Edentulous Maxilla, run by Institute Franci at 1 site in Italy.
Trial summary
The primary objective of the present study is to evaluate the marginal bone level changes occurring in total edentulous patients treated with six or four implants. Secondary objective overall survival rate soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth (PPD) at baseline and… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Maxilla
- What is being tested?
- 4 vs 6 implant treatment in the maxilla
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2013to Sep 2024
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age > 18 years;
- edentulous maxilla or having hopeless remaining teeth that are intended to be extracted;
- willingness to comply with all study requirements and to sign the IC;
- have sufficient amount of bone (8mm or more) in the recipient site to allow implant placement without bone augmentation procedures.
Who cannot join
- bone defects associated with severe knife-edge ridges;
- bone defects resulting from tumor resection;
- tobacco abuse (> 10 cigarettes/day);
- severe kidney and liver disease;
- history of radiotherapy in the head and neck region;
- chemotherapy for treatment of malignant tumors at the time of the surgical procedure;
Show all 12Show fewer
- uncontrolled diabetes;
- active periodontal disease involving the residual opposite dentition;
- mucosal disease, such as lichen planus, in the areas to be treated;
- poor oral hygiene;
- non-compliant patients;
- situations judged inconvenient(by the investigator) for the surgical treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Four Versus Six Endosseous Implants to be Used in the Rehabilitation of Totally Edentulous Patient in the Maxilla With Titanium Milled Framework
The primary objective of the present study is to evaluate the marginal bone level changes occurring in total edentulous patients treated with six or four implants.
Secondary objective
- overall survival rate
- soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth (PPD) at baseline and after 1,3,5 years
- prosthetic survival rates including screw or abutment loosening, framework or veneer fractures
Read the detailed description
METHODS/PROCEDURES A randomized controlled multi-center clinical study is designed to determine whether a difference exists between the outcome of treatment when Astra tech implants are placed according to a six or a four implants protocol. The investigation will be performed in four centers: three in Italy affiliated to Institute Franci and one affiliated to the Department of Prosthodontics, Faculty of Odontology, Malmö University. In each center the clinician and the examiner will be the same person. The study protocol will be approved by the Regional Human Review Board of Padova General Hospital.
An investigators' meeting will be arranged prior to the starting with the patients' recruitment. Following a screening examination, subjects who will meet the inclusion criteria, will sign the Informed Consent and will be enrolled in the study. The period of patient enrollment will begin on January 1 2013 and ends December 31 2013.
The patients will be randomized with a method based on the use of sealed opaque envelopes. The cases will be assigned to two different treatment groups:
Group A- four implants (Test) Group B- six implants (Control)
Pre-treatment Patient data, medical history, clinical and radiographic examination will be recorded for each patient. Clinical photographs will be taken in frontal, occlusal and lateral projections.
Periodontal, endodontic and open caries lesions will be treated prior to implant installation. All patients will receive careful oral hygiene instructions and training in self-performed
plaque control measure. CT scan computed exams will be carried out. Plaster models and diagnostic wax-up will be carried out.
First Surgical Phase (Implant Installation) The patient will receive antibiotic prophylaxis (Amoxicillin 1gr) one hour prior to surgery and after the completion of implant installation until suture removal with 1gr three times a day. (If the patient is allergic to amoxicillin the examiner prescribes antibiotics at his own discretion at the same posology).
The surgical treatment will be performed under local anesthesia. In case of remaining teeth, they will be extracted with conventional technique before implants' placement. (13-14) Implants will be placed according to the guidelines described in the Astra Tech® manual "Surgical procedures", using a two-stage protocol.
Implant spinning during the positioning of the cover screw will be registered as positive, if present, or negative.
The operation will be finalized by a careful adaption of the flaps by means of an accurate suture in order to obtain a full periosteal coverage.
Intraoral clinical photographs before, during and after surgery will be taken.
Post-operative care The patients will be instructed to rinse with chlorhexidine 0.12% mouthrinse and will be told to rinse with the antiseptic solution three times a day for 2 weeks. The patients will be advised to take NSAIDs for pain relief at their own discretion.
Liquid and semisolid food will be prescribed for the first post-operative week, after which the sutures will be removed.
Two weeks after the operation the denture will be properly relined until the second stage surgery.
Patients will be controlled at third and sixth weeks.
Second surgical phase and Prosthetic procedures After eight weeks (+ 2) of healing in both groups (A and B) Uni Abutment 45° connection procedure will be performed. Impression with a customized spoon and Impregum material will be taken and the prosthetic procedure will be performed according to the Atlantis-Isus recommendations.
After 6 weeks (+ 2) from Uni Abutment connection the definitive full-arch fixed dental prostheses screw retained will be applied. The prosthesis will be made to accomplish the normal hygienic procedures. All prosthetic procedures will be made in accordance to the Astra Tech procedures \& products manuals.
The length of bridge cantilevers will be duly calculated to minimize implant overloading according to the Atlantis-Isus recommendations (15)
Post-prosthetic measurements Clinical measurements Clinical examinations will be performed immediately following the installation of the definitive prosthesis (Baseline-Loading) and after 1, 3, and 5 years. In particular, plaque and soft-tissue inflammation will be registered. Clinical photographs will be taken at each interval point.
Plaque: the presence of plaque will be scored at each implant site as well as at level of the remaining teeth on four surfaces (buccal, lingual/palatal, mesial, distal). The mean percentage of plaque harboring surfaces will be calculated using the case as the unit.
Soft-tissue inflammation: the presence of soft-tissue inflammation (bleeding on probing) will be assessed on buccal, lingual/palatal, mesial, distal aspects of each implant. The mean percentage of inflamed sites will be calculated using the case as the unit.
Radiographic measurements Peri-apical radiographs will be taken at prosthesis insertion (Baseline) and after 1, 3, and 5 years.
The radiographs will be taken with an X-ray apparatus supplied with a long cone by the examiner each visiting time. Rinn centrators will be used to ensure reproducibility in the measurement of marginal bone level change.
The radiographic images will be analysed at the Department of Radiology of Sahlgrenska Academy, Gothenburg University by experienced radiologists who will be otherwise not involved in the study.
- Conditions
- Edentulous Maxilla
- Being tested
- 4 vs 6 implant treatment in the maxilla
- Keywords
- Implantology, oral surgery, bone level changes, marginal bone level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 vs 6 implant treatment in the maxillaDevice
Also called Astratech TX implant , Densply Implant (company name)
| Study group | Role | What they receive |
|---|---|---|
| Test -4 implants- | Experimental | Evaluate marginal bone level (MBL) changes at implants that are placed in total edentulous patient when they are treated with four with titanium Cad/Cam framework. Receives: Device: 4 vs 6 implant treatment in the maxilla |
| Control -6 implants- | Active comparator | Evaluate marginal bone level (MBL) changes at implants that are placed in total edentulous patient when they are treated with six with titanium Cad/Cam framework Receives: Device: 4 vs 6 implant treatment in the maxilla |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone resorption in millimeter from the the implant to the bone crest.
Measured: 1 year
Marginal bone resorption in millimeter from the the implant to the bone crest.
Measured: 3 year
Marginal bone resorption in millimeter from the the implant to the bone crest.
Measured: 5 year
Secondary outcomes (3)
Fracture of the prosthetic components
Measured: 1 year
Fracture of the prosthetic components
Measured: 3 year
Fracture of the prosthetic components
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startDec 2013
- Primary completionSep 2024
- Study completionSep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute Franci
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toia Marco, Institute Franci
- Investigators
- Denis Cecchinato, DDS, Study director, Franci Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405169
- Sponsor's protocol ID
- IIS-D-2012-031
- Status last verified
- Feb 2025
- First submitted
- 16 Mar 2015
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Toia M, Moreira CS, Dias DR, Corra E, Ravida A, Cecchinato D. Fixed Full-Arch Maxillary Prostheses Supported by Four Versus Six Implants: 5-Year Results of a Multicenter Randomized Clinical Trial. Clin Oral Implants Res. 2025 Mar;36(3):298-313. doi: 10.1111/clr.14383. Epub 2024 Nov 24.
PubMed 39581887
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four Versus Six Endosseous Implants to be Used in the Rehabilitation of Totally Edentulous Patient in the Maxilla With Titanium Milled Framework
- ClinicalTrials.gov ID
- NCT02405169
- Acronym / sponsor ID
- IIS-D-2012-031
- Conditions
- Edentulous Maxilla
- Keywords
- Implantology, oral surgery, bone level changes, marginal bone level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Institute FranciUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Sep 2024 (actual)
- Study completion
- Sep 2024 (actual)
- First posted
- 1 Apr 2015 (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.
The primary objective of the present study is to evaluate the marginal bone level changes occurring in total edentulous patients treated with six or four implants.
Secondary objective
- overall survival rate
- soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth (PPD) at baseline and after 1,3,5 years
- prosthetic survival rates including screw or abutment loosening, framework or veneer fractures
Detailed description
METHODS/PROCEDURES A randomized controlled multi-center clinical study is designed to determine whether a difference exists between the outcome of treatment when Astra tech implants are placed according to a six or a four implants protocol. The investigation will be performed in four centers: three in Italy affiliated to Institute Franci and one affiliated to the Department of Prosthodontics, Faculty of Odontology, Malmö University. In each center the clinician and the examiner will be the same person. The study protocol will be approved by the Regional Human Review Board of Padova General Hospital.
An investigators' meeting will be arranged prior to the starting with the patients' recruitment. Following a screening examination, subjects who will meet the inclusion criteria, will sign the Informed Consent and will be enrolled in the study. The period of patient enrollment will begin on January 1 2013 and ends December 31 2013.
The patients will be randomized with a method based on the use of sealed opaque envelopes. The cases will be assigned to two different treatment groups:
Group A- four implants (Test) Group B- six implants (Control)
Pre-treatment Patient data, medical history, clinical and radiographic examination will be recorded for each patient. Clinical photographs will be taken in frontal, occlusal and lateral projections.
Periodontal, endodontic and open caries lesions will be treated prior to implant installation. All patients will receive careful oral hygiene instructions and training in self-performed
plaque control measure. CT scan computed exams will be carried out. Plaster models and diagnostic wax-up will be carried out.
First Surgical Phase (Implant Installation) The patient will receive antibiotic prophylaxis (Amoxicillin 1gr) one hour prior to surgery and after the completion of implant installation until suture removal with 1gr three times a day. (If the patient is allergic to amoxicillin the examiner prescribes antibiotics at his own discretion at the same posology).
The surgical treatment will be performed under local anesthesia. In case of remaining teeth, they will be extracted with conventional technique before implants' placement. (13-14) Implants will be placed according to the guidelines described in the Astra Tech® manual "Surgical procedures", using a two-stage protocol.
Implant spinning during the positioning of the cover screw will be registered as positive, if present, or negative.
The operation will be finalized by a careful adaption of the flaps by means of an accurate suture in order to obtain a full periosteal coverage.
Intraoral clinical photographs before, during and after surgery will be taken.
Post-operative care The patients will be instructed to rinse with chlorhexidine 0.12% mouthrinse and will be told to rinse with the antiseptic solution three times a day for 2 weeks. The patients will be advised to take NSAIDs for pain relief at their own discretion.
Liquid and semisolid food will be prescribed for the first post-operative week, after which the sutures will be removed.
Two weeks after the operation the denture will be properly relined until the second stage surgery.
Patients will be controlled at third and sixth weeks.
Second surgical phase and Prosthetic procedures After eight weeks (+ 2) of healing in both groups (A and B) Uni Abutment 45° connection procedure will be performed. Impression with a customized spoon and Impregum material will be taken and the prosthetic procedure will be performed according to the Atlantis-Isus recommendations.
After 6 weeks (+ 2) from Uni Abutment connection the definitive full-arch fixed dental prostheses screw retained will be applied. The prosthesis will be made to accomplish the normal hygienic procedures. All prosthetic procedures will be made in accordance to the Astra Tech procedures \& products manuals.
The length of bridge cantilevers will be duly calculated to minimize implant overloading according to the Atlantis-Isus recommendations (15)
Post-prosthetic measurements Clinical measurements Clinical examinations will be performed immediately following the installation of the definitive prosthesis (Baseline-Loading) and after 1, 3, and 5 years. In particular, plaque and soft-tissue inflammation will be registered. Clinical photographs will be taken at each interval point.
Plaque: the presence of plaque will be scored at each implant site as well as at level of the remaining teeth on four surfaces (buccal, lingual/palatal, mesial, distal). The mean percentage of plaque harboring surfaces will be calculated using the case as the unit.
Soft-tissue inflammation: the presence of soft-tissue inflammation (bleeding on probing) will be assessed on buccal, lingual/palatal, mesial, distal aspects of each implant. The mean percentage of inflamed sites will be calculated using the case as the unit.
Radiographic measurements Peri-apical radiographs will be taken at prosthesis insertion (Baseline) and after 1, 3, and 5 years.
The radiographs will be taken with an X-ray apparatus supplied with a long cone by the examiner each visiting time. Rinn centrators will be used to ensure reproducibility in the measurement of marginal bone level change.
The radiographic images will be analysed at the Department of Radiology of Sahlgrenska Academy, Gothenburg University by experienced radiologists who will be otherwise not involved in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test -4 implants- | Experimental | Device: 4 vs 6 implant treatment in the maxillaEvaluate marginal bone level (MBL) changes at implants that are placed in total edentulous patient when they are treated with four with titanium Cad/Cam framework. |
| Control -6 implants- | Active comparator | Device: 4 vs 6 implant treatment in the maxillaEvaluate marginal bone level (MBL) changes at implants that are placed in total edentulous patient when they are treated with six with titanium Cad/Cam framework |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18 years;
- edentulous maxilla or having hopeless remaining teeth that are intended to be extracted;
- willingness to comply with all study requirements and to sign the IC;
- have sufficient amount of bone (8mm or more) in the recipient site to allow implant placement without bone augmentation procedures.
Key exclusion criteria (12 listed)
- bone defects associated with severe knife-edge ridges;
- bone defects resulting from tumor resection;
- tobacco abuse (> 10 cigarettes/day);
- severe kidney and liver disease;
- history of radiotherapy in the head and neck region;
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 |
|---|---|---|
| 4 vs 6 implant treatment in the maxillaAlso: Astratech TX implant , Densply Implant (company name) | Device | Control -6 implants-, Test -4 implants- |
Primary outcome
Marginal bone resorption in millimeter from the the implant to the bone crest.
Time frame: 1 year
Marginal bone resorption in millimeter from the the implant to the bone crest.
Time frame: 3 year
Marginal bone resorption in millimeter from the the implant to the bone crest.
Time frame: 5 year
3 secondary outcomes
Fracture of the prosthetic components
Time frame: 1 year
Fracture of the prosthetic components
Time frame: 3 year
Fracture of the prosthetic components
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Derived from this study: PubMed 39581887Toia M, Moreira CS, Dias DR, Corra E, Ravida A, Cecchinato D. Fixed Full-Arch Maxillary Prostheses Supported by Four Versus Six Implants: 5-Year Results of a Multicenter Randomized Clinical Trial. Clin Oral Implants Res. 2025 Mar;36(3):298-313. doi: 10.1111/clr.14383. Epub 2024 Nov 24.
Related trials for Edentulous Maxilla
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Not yet recruiting
Clinical and Radiographic Comparison of Two Implant-Abutment Connections
Dental Implant, Edentulous Alveolar Ridge
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
Not yet recruitingEarly Phase 1
Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin
Partially Edentulous Maxilla
Not yet recruiting
3D Metrology-Based Comparison of Functional Casts Made With Conventional and 3D-Printed Custom Trays
Edentulism Complete
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.
Denis Cecchinato, DDS study director
Franci Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 vs 6 implant treatment in the maxilla in people with Edentulous Maxilla, run by Institute Franci at 1 site in Italy.
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 12 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: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Marginal bone resorption in millimeter from the the implant to the bone crest. (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02405169, which also lists 1 linked publication.
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 4 Feb 2025.