Dental Implant Survival RatePhase 4NCT01836744

Survival Rate of Dental Implants Placed in Sinus Lift Performed With Two Different Grafts

A Phase 4 study testing Survival rate dental implant (OsseoSpeed™) in people with Dental Implant Survival Rate, run by Grupo de Investigação: Cirurgia Oral, Peridontologia, Implantologia at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Previous in a randomized way, it will be performance 12 bilateral sinus lift with autologous bone in one side and the in other with xenograft material. After 6 mouths we will place 1 to 3 implants in each side and analyse the survival rate and possibles differences related to; prosthesis failure; biological and… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dental Implant Survival Rate
What is being tested?: Survival rate dental implant (OsseoSpeed™)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 sitePortugal
Study dates: 18 Mar 2013to 30 Jul 2023
Phase: Phase 4
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

Any partially edentulous patient having bilateral edentulism in the posterior maxillae (premolars and/or molars) with a similar degree of bone resorption requiring one to three implants at each side, being 18 years or older, and able to sign an informed consent. For all the potentially included patients preoperative CBCT (cone beam computed tomography) or CT scans and OPGs (orthopantomograph)must be obtained and attached to the files. The vertical bone height below the maxillary sinus at the implant sites must be of 1-5 mm and bone thickness at least 6 mm measured on CBCT (cone-beam computed tomography)or CT scans. Smokers will be included and patients will be grouped into: 1) non smokers; 2) light smokers ≤ 10 cigarettes/day; 3) heavy smokers ≥ 11 cigarettes/day, according to what they declare.

Who cannot join

General contraindications to implant surgery.
Patients irradiated in the head and neck area.
Immunosuppressed or immunocompromised patients.
Patients treated or under treatment with intravenous amino-bisphosphonates.
Patients with untreated periodontitis.
Patients with poor oral hygiene and motivation.

Show all 15Show fewer

Uncontrolled diabetes.
Pregnancy or nursing.
Substance abuser.
Psychiatric problems or unrealistic expectations.
Lack of opposite occluding dentition in the area intended for implant placement.
Patients with an acute or chronic sinusitis.
Patients participating in other trials, if the present protocol cannot be properly adhered too.
Patients referred only for implant placement.
Patient unable to be followed for 5 years after loading.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

University of Porto, Faculty of Dental Medicine
Porto, Porto District, 4200-256

Other trials in Portugal

About this study

Read the detailed description

The study will be performance in 12 patients submitted to a bilateral sinus lift procedure.

Six months after the bilateral sinus lifting performed in a randomly way, using as graft materials (100% of autologous bone graft or 100% of xenograft), will be placed 1 to 3 implants in each maxillary sinus.

Wait more six months to expose the implant. At the end of 13 months after implant placement it should be in charge.

Implant placement (6 months after sinus lift procedure):

Both sides should be treated during the same session.
Patients will receive 2g Amoxicillin one hour before the procedure. Patients allergic to penicillin will be given Clindamycin 600 mg 1 hour before implant placement procedure.
Patients will rinse for 1 minute prior to flap elevation with 0.12% chlorhexidine mouthwash.
After delivery of local anaesthesia, incision and flap elevation, the recommendation of the various implant manufacturers will be followed for placing 1 to 3 implants 9-11 mm long per posterior upper (premolar-molar areas) below the maxillary sinus and a histological sample for each side will be collected.
The neck of the implants will be placed flush to the bone and implants will be submerged under the soft tissues and flaps will be sutured.
Baseline intraoral radiographs of the study implants have to be taken.

Post-implant placement instructions:

Chlorhexidine mouthwash 0.12% for 1 minute twice a day for 2 weeks.
Ibuprofen 400 mg will be prescribed to be taken 2-4 times a day during meals, but patients will be instructed not to take them in absence of pain. Patients with gastric problems or allergic to ibuprofen will receive paracetamol 1 g instead.
Sutures will be removed after 10 days.

Abutment connection (6 months after implant placement):

Both sides should be treated during the same session.
Patients will rinse for 1 minute prior to flap incision with 0.12% chlorhexidine mouthwash.
Mucosa can be punched or a flap will be elevated according to personal preference of the surgeon, it is important that both sides are treated in the same way.
Individual implants will be tested for stability.
Impressions will be taken.
Healing abutments will be placed.

Post-abutment connection instructions:

Chlorhexidine mouthwash 0.12% for 1 minute twice a day for 2 weeks.
Ibuprofen 400 mg will be prescribed to be taken 2-4 times a day during meals, but patients will be instructed not to take them in absence of pain. Patients with gastric problems or allergic to ibuprofen will receive paracetamol 1 g instead.
Sutures will be removed after 10 days.

Prosthetic phase:

Within one month after abutment connection, implants will be manually tested for stability.
Provisional reinforced acrylic restorations or definitive screw-retained or provisionally cemented (to allow implant stability assessment) metal-resin or metal-ceramic bridges rigidly joining the 2 or 3 implants will be delivered.
Implants will be splinted under the same prosthesis, each implant supporting one tooth element.
The connection of teeth with implants under the same prosthesis is not allowed.
Similar procedures and materials have to be used in the same patient.
The occlusal surface will be in slight contact with the opposite dentition.
Intraoral radiographs and clinical pictures of the study implants will be taken at initial loading.

Maintenance:

All patients will be recalled every 6 months after prosthetic loading for delivery of professional maintenance on individual basis.
Dental occlusion will be evaluated at each maintenance visit.

Conditions: Dental Implant Survival Rate
Being tested: Survival rate dental implant (OsseoSpeed™)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Survival rate dental implant (OsseoSpeed™)Device
Also called OsseoSpeed™ dental implant

Study groups in NCT01836744
Study group	Role	What they receive
survival rate autologous bone	Active comparator	dental implant placement in the previous sinus lift side with autologous bone; dental implant placement in the previous sinus lift side with xenograft material side; Receives: Device: Survival rate dental implant (OsseoSpeed™)
survival rate axenograft material	Active comparator	dental implant placement in the previous sinus lift side with xenograft material side; Receives: Device: Survival rate dental implant (OsseoSpeed™)

What is being measured

The primary outcome is the main question the study is designed to answer.

Histological and histomorphological analysis
Histological and histomorphological analysis of the bone graft
Measured: 6 mounths
radiological analysis
Comparation of the bone gain in a radiological analysis (initial and at 6 months)
Measured: 6 mounths
Clinical evaluation - questionary
questionary about patient preference treatment
Measured: 6 mounths
Implant failure
implant mobility assessed manually with the removed prosthesis and/or any infection dictating implant removal. Assessments will be done at delivery of the provisional and definitive prostheses, 1, 3 and 5 years of loading by tightening the abutment screws with the removed prostheses.
Measured: up to 5 years of loading
Prosthesis failure
when prosthesis placement will not be possible due to implant failure or secondary to implant failure.
Measured: up to 5 years of loading
Peri-implant marginal bone level changes
Peri-implant marginal bone level changes assessed on periapical radiographs taken with the paralleling technique at implant placement, at initial prosthetic loading, 1 and 5 years follow-up in function.
The distance between marginal bone level and implant/abutment junction, approximated to half mm, will be measured at both mesial and distal sides and averaged. Bone level changes at single implants will be averaged at patients level and then at group level.
Measured: up to 5 years
Biological complications
Biological complications (number and type). Particular attention will be used to assess possible sinus pathologies.
Measured: up to 5 years
Prosthetic complications
Prosthetic complications (number and type).
Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 201330 Jul 2023

First posted22 Apr 2013 (estimated)
Study start18 Mar 2013
Primary completion20 Jun 2017
Study completion30 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dental Implant Survival RateStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: randomizes split month trial: * one sinus autologous bone graft * other sinus - xenograft - osteobiol Mp3
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01836744
Sponsor's protocol ID: D-2012-024
Status last verified: Sep 2023
First submitted: 11 Mar 2013
Last updated: 13 Sep 2023
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Follow-up of a Randomised Controlled Study of Surgical Peri-implantitis Treatment
Success, Dental Implant Survival Rate
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Immediate Restoration of a New Implant With High Primary Stability
Dental Implants, Immediate Dental Implant Loading
Recruiting
Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System
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Enrolling by invitation
Prospective Longitudinal Clinical Study for the Evaluation of Peri-implant Tissue and Osseointegration After Rehabilitation With Osseointegrated Implants
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Study Evaluating the Performance and Safety in the Medium and Long Term of Global D Implant-prosthetic Systems
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All Dental Implant Survival Rate trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Survival Rate of Dental Implants Placed in Sinus Lift Performed With Two Different Grafts
ClinicalTrials.gov ID: NCT01836744
Acronym / sponsor ID: D-2012-024
Conditions: Dental Implant Survival Rate
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Grupo de Investigação: Cirurgia Oral, Peridontologia, ImplantologiaUniversity, hospital or other
Collaborators: Universidade do Porto, Dentsply Sirona Implants and Consumables, Tecnoss OsteoBiol
Study start: 18 Mar 2013 (actual)
Primary completion: 20 Jun 2017 (actual)
Study completion: 30 Jul 2023 (actual)
First posted: 22 Apr 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.

Detailed description

The study will be performance in 12 patients submitted to a bilateral sinus lift procedure.

Wait more six months to expose the implant. At the end of 13 months after implant placement it should be in charge.

Implant placement (6 months after sinus lift procedure):

Both sides should be treated during the same session.
Patients will receive 2g Amoxicillin one hour before the procedure. Patients allergic to penicillin will be given Clindamycin 600 mg 1 hour before implant placement procedure.
Patients will rinse for 1 minute prior to flap elevation with 0.12% chlorhexidine mouthwash.
After delivery of local anaesthesia, incision and flap elevation, the recommendation of the various implant manufacturers will be followed for placing 1 to 3 implants 9-11 mm long per posterior upper (premolar-molar areas) below the maxillary sinus and a histological sample for each side will be collected.
The neck of the implants will be placed flush to the bone and implants will be submerged under the soft tissues and flaps will be sutured.
Baseline intraoral radiographs of the study implants have to be taken.

Post-implant placement instructions:

Chlorhexidine mouthwash 0.12% for 1 minute twice a day for 2 weeks.
Ibuprofen 400 mg will be prescribed to be taken 2-4 times a day during meals, but patients will be instructed not to take them in absence of pain. Patients with gastric problems or allergic to ibuprofen will receive paracetamol 1 g instead.
Sutures will be removed after 10 days.

Abutment connection (6 months after implant placement):

Both sides should be treated during the same session.
Patients will rinse for 1 minute prior to flap incision with 0.12% chlorhexidine mouthwash.
Mucosa can be punched or a flap will be elevated according to personal preference of the surgeon, it is important that both sides are treated in the same way.
Individual implants will be tested for stability.
Impressions will be taken.
Healing abutments will be placed.

Post-abutment connection instructions:

Chlorhexidine mouthwash 0.12% for 1 minute twice a day for 2 weeks.
Ibuprofen 400 mg will be prescribed to be taken 2-4 times a day during meals, but patients will be instructed not to take them in absence of pain. Patients with gastric problems or allergic to ibuprofen will receive paracetamol 1 g instead.
Sutures will be removed after 10 days.

Prosthetic phase:

Within one month after abutment connection, implants will be manually tested for stability.
Provisional reinforced acrylic restorations or definitive screw-retained or provisionally cemented (to allow implant stability assessment) metal-resin or metal-ceramic bridges rigidly joining the 2 or 3 implants will be delivered.
Implants will be splinted under the same prosthesis, each implant supporting one tooth element.
The connection of teeth with implants under the same prosthesis is not allowed.
Similar procedures and materials have to be used in the same patient.
The occlusal surface will be in slight contact with the opposite dentition.
Intraoral radiographs and clinical pictures of the study implants will be taken at initial loading.

Maintenance:

All patients will be recalled every 6 months after prosthetic loading for delivery of professional maintenance on individual basis.
Dental occlusion will be evaluated at each maintenance visit.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: randomizes split month trial: * one sinus autologous bone graft * other sinus - xenograft - osteobiol Mp3

Arm	Type	Receives
survival rate autologous bone	Active comparator	Device: Survival rate dental implant (OsseoSpeed™)dental implant placement in the previous sinus lift side with autologous bone; dental implant placement in the previous sinus lift side with xenograft material side;
survival rate axenograft material	Active comparator	Device: Survival rate dental implant (OsseoSpeed™)dental implant placement in the previous sinus lift side with xenograft material side;

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Any partially edentulous patient having bilateral edentulism in the posterior maxillae (premolars and/or molars) with a similar degree of bone resorption requiring one to three implants at each side, being 18 years or older, and able to sign an informed consent. For all the potentially included patients preoperative CBCT (cone beam computed tomography) or CT scans and OPGs (orthopantomograph)must be obtained and attached to the files. The vertical bone height below the maxillary sinus at the implant sites must be of 1-5 mm and bone thickness at least 6 mm measured on CBCT (cone-beam computed tomography)or CT scans. Smokers will be included and patients will be grouped into: 1) non smokers; 2) light smokers ≤ 10 cigarettes/day; 3) heavy smokers ≥ 11 cigarettes/day, according to what they declare.

Key exclusion criteria (15 listed)

General contraindications to implant surgery.
Patients irradiated in the head and neck area.
Immunosuppressed or immunocompromised patients.
Patients treated or under treatment with intravenous amino-bisphosphonates.
Patients with untreated periodontitis.

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
Survival rate dental implant (OsseoSpeed™)Also: OsseoSpeed™ dental implant	Device	survival rate autologous bone, survival rate axenograft material

Primary outcome

Histological and histomorphological analysis
Time frame: 6 mounths
Histological and histomorphological analysis of the bone graft
radiological analysis
Time frame: 6 mounths
Comparation of the bone gain in a radiological analysis (initial and at 6 months)
Clinical evaluation - questionary
Time frame: 6 mounths
questionary about patient preference treatment
Implant failure
Time frame: up to 5 years of loading
implant mobility assessed manually with the removed prosthesis and/or any infection dictating implant removal. Assessments will be done at delivery of the provisional and definitive prostheses, 1, 3 and 5 years of loading by tightening the abutment screws with the removed prostheses.
Prosthesis failure
Time frame: up to 5 years of loading
when prosthesis placement will not be possible due to implant failure or secondary to implant failure.
Peri-implant marginal bone level changes
Time frame: up to 5 years
Peri-implant marginal bone level changes assessed on periapical radiographs taken with the paralleling technique at implant placement, at initial prosthetic loading, 1 and 5 years follow-up in function. The distance between marginal bone level and implant/abutment junction, approximated to half mm, will be measured at both mesial and distal sides and averaged. Bone level changes at single implants will be averaged at patients level and then at group level.
Biological complications
Time frame: up to 5 years
Biological complications (number and type). Particular attention will be used to assess possible sinus pathologies.
Prosthetic complications
Time frame: up to 5 years
Prosthetic complications (number and type).

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 13 Sep 2023.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Dental Implant Survival Rate

Not yet recruitingObservational study
Follow-up of a Randomised Controlled Study of Surgical Peri-implantitis Treatment
Success, Dental Implant Survival Rate
Not yet recruiting
Immediate Restoration of a New Implant With High Primary Stability
Dental Implants, Immediate Dental Implant Loading
Recruiting
Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System
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Enrolling by invitation
Prospective Longitudinal Clinical Study for the Evaluation of Peri-implant Tissue and Osseointegration After Rehabilitation With Osseointegrated Implants
Osseointegration Failure of Dental Implant, Periimplantitis
RecruitingObservational study
Study Evaluating the Performance and Safety in the Medium and Long Term of Global D Implant-prosthetic Systems
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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.

Francisco Correia, DDS, Msc, PhD principal investigator

Universidade do Porto

Ricardo Faria Almeida, DDS, Msc, PhD study director

Universidade do Porto

Antonio Campos Felino, DDS, PhD study chair

Universidade do Porto

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 15 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 13 Sep 2023. 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 Portugal. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Histological and histomorphological analysis (time frame: 6 mounths). The study lists 8 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 NCT01836744.

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 13 Sep 2023.