Insufficient Bone Volume in Posterior MaxillaNCT01060644
Maxillary Sinus Floor Elevation Following Simultaneous Implant Installation Without Graft Material
An observational study of Insufficient Bone Volume in Posterior Maxilla, run by Carmel Medical Center at 1 site in Israel.
Trial summary
The present study describes and evaluates the surgical protocol for sinus mucosal lining elevation of the maxillary sinus for Dental Implant Insertion without Bone grafting Underneath the Sinus Membrane. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insufficient Bone Volume in Posterior Maxilla
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Jan 2013
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients (women, men) with a range of a age 18-65 years will be consecutively included. The patients will be referred to the Department of Oral and Maxillofacial Surgery, Carmel Medical Center, Haifa, for dental implant treatment in the posterior maxilla from every Dental Clinic in Israel
Who may be able to join
- Healthy patient.
- Patients that have a rehabilitation dentist.
- Healthy conditions of Maxillary Sinuses and Oral Mucosa.
- Healthy bone determined by Panoramic X-ray.
- Sub-antral bone at least 4 mm as measured on CT.
- Have a good oral hygiene condition.
- Patient that does not participate in other clinical study.
- Patient able to read and understand and sign the informed consent.
Who cannot join
- Unhealthy patients, with recorded medical history diseases as: diabetes, mellitus, heart diseases, renal failure, osteoporosis.
- Patients treated with anticoagulation medication (Coumadin, Plavix).
- Patients treated with Oral Bisphosphonate drugs (as Fosalan).
- Patient with a history of Chemotherapy or Radiotherapy treatment.
- Unhealthy conditions of Maxillary Sinuses.
- Patient without prosthetic rehabilitation treatment plan ) approved by the referred dentist.
Trial locations and contacts
1 site in 1 country.
About this study
The present study describes and evaluates the surgical protocol for sinus mucosal lining elevation of the maxillary sinus for Dental Implant Insertion without Bone grafting Underneath the Sinus Membrane.
Read the detailed description
Restoration of lost dentition in the severely atrophic posterior maxilla has for the last 2 decades been successfully treated with various sinus augmentation techniques and installation of dental implants. The use of graft material is anticipated to be necessary; however, recent studies have demonstrated that the mere lifting of the sinus mucosal lining and simultaneous placement of implants result in bone formation. This study was conducted in order to evaluate simultaneous sinus mucosal lining elevation and installation of dental implants without any graft material.
The present study describes and evaluates a modification of the surgical protocol for sinus mucosal lining elevation and simultaneous installation of osseointegrated implants with a MIS implant system (Seven ™) ,in 20 patients.
Preoperative Examination: (Screening):
- Medical History
- Clinical Examination
- Oral hygiene.
- Oral mucosa condition.
- Number of missing teeth in the posterior maxilla.
- Radiographic Examination (CT and Panoramic X-ray)
- Sinus Maxillary condition.
- Sub-antral bone height.
- Bone jaw condition. Selected patients under the "inclusion criteria" will be included in the study after they will have explanation and signed on informed consent.
Surgery:
All patients will be operated on under local anesthesia (2% Xylocaine Dental with epinephrine 1:100,000;) or General anesthesia ( the type of the anesthesia will be decided by the patients) at Carmel medical center Haifa.. Preoperative antibiotics will orally administered 45 minutes before surgery; patients routinely received 2 g of Augmentin or 600 mg of clindamycin (when allergic to penicillin).and 6mg of Dexamethasone 1 hour before surgery.
Surgical Technique:
The posterior maxillary edentulous area and the maxillary sinus wall will be exposed via a crestal incision and a buccal muco-periosteal flap will be raised. Osteotomy in a oval or rectangular fashion will be made with round Drill 5 mm radius in the anterior wall of the sinus, 5 to 6 mm cranial to the intended implant site (Fig 1). With small sharp elevators the cortical bony window will be pulled in the sinus cavity.
Perforations of various sizes of the sinus mucosal lining will be treated by drilling small holes in the bone above the cortical window to elevate and suture the mucosal lining to that level using absorbable sutures (Vicryl 6-0). If there is success in this technique we will use a small piece of periosteum (taken from the buccal flap) which will be placed as a lid over a perforation of the sinus mucosal lining. If the perforations are so small (less than 1 mm) then further dissection of the mucosal lining and "tenting" by the implants will be considered satisfactory for a blood clot to form around the implants.
After the elevation, implants will be installed in the residual sub-antral bone. The remaining bone height will be recorded with a depth gauge during surgery. Primary implant stability will be noted manually at installation. A stabilizing wrench will be used when removing the implant carrier in all cases.
To achieve implant stability in the cases of small remaining levels of vertical subantral bone, the protocol of installing the MIS system dental implant was modified in its last preparation step. The final conical burr was leveled into the bone 1 to 2 mm less than the recommended standard protocol in cases with only 2 to 3 mm residual bone. Thus, a slightly smaller hole for the implant was prepared and the implant could be placed with better primary stability, utilizing the effect of the conical design and the retention of the microthreads in the superior part, adding an extra effect to the placement and thereby achieving sufficient primary stability. The compartment around the implants under the sinus mucosal lining in the sinus floor will be filled with blood from surrounding bleeding (Fig 2), and dental membrane (Zimmer Ltd.) will be placed on the open window, then the incision will be closed with resorbable sutures (Vicryl 3/0. Ethicon Inc
Postoperative Care:
Analgesics will be prescribed with Optalgin or with a nonsteroidal anti-inflammatory drug for 1 to 2 weeks following the surgery. Antibiotic treatment will be continue for 10 days postoperatively with Augmentin 875mg Twice a day (or clindamycin, 300 mg 3 times daily for penicillin allergic patients). Patients should be instructed not to blow their nose and to use nasal spray saline for 14 days after surgery. Wearing dentures will not be allowed for 10 days following the surgery.
Patients will be reviewed and sutures taken out after 7 to 10 days. Clinical and Radiological Follow-up The patient will be recalled to the out patient clinic in Carmel Medical Center, for a follow up. All patients will be checked in the surgery site and x-ray radiograph will be made.
Radiological follow up:
Periapical radiographs and Panoramic X-ray will be used for measurements of 1) the height of the residual alveolar bone at each implant site, and 2) the height of newly formed bone in the maxillary sinus in relation to each implant. Measurements will be made manually with a millimeter scale. The cervical micro-threaded area of the implant will be used as a reference point during measurement.
Criteria for considering the procedure as successful:
- Successful implants ( no pain, no infection, stable implants) at the uncovering procedure.
- Periapical and panoramic x-ray at the endpoint shows a bone formation around the implant inside the maxillary sinus.
Uncovering of the implant will be done 6 month after the surgery. All patients will be operated on under local anesthesia (2% Xylocaine Dental with epinephrine 1:100,000;) the implant instillation area and the maxillary sinus wall will be exposed via a crestal incision and a buccal mucoperiosteal flap will be raised.
- A healing cap will be inserted in the implant.
- A punch of 2mm biopsy will be take from the maxillary wall. The incision will be closed with resorbable sutures (Vicryl 3/0. Ethicon Inc) around the healing cap.
The referring dentists will carried out the prosthetic rehabilitation after two weeks for the uncovering procedure. All patients will be recalled for follow up after the prosthetic rehabilitation 2 and 4 months in our out patients clinic.
Statistics Descriptive statistics will be used and the correlation of results will be confirmed with linear regression analysis.
- Keywords
- Maxillary Sinus, Bone Augmentation, Dental Implant, Sinus Membrane
What is being measured
The primary outcome is the main question the study is designed to answer.
CT evaluation before Dental Implant uncovering
Measured: In the end of the treatment
CT evaluation of bone regeneration
Measured: In the end of each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startMar 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insufficient Bone Volume in Posterior 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Samer Srouji, DMD, Ph.D, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060644
- Sponsor's protocol ID
- CMC-08-0015-CTIL
- Status last verified
- Nov 2013
- First submitted
- 31 Jan 2010
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary Sinus Floor Elevation Following Simultaneous Implant Installation Without Graft Material
- ClinicalTrials.gov ID
- NCT01060644
- Acronym / sponsor ID
- CMC-08-0015-CTIL
- Keywords
- Maxillary Sinus, Bone Augmentation, Dental Implant, Sinus Membrane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- Mar 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Feb 2010 (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 present study describes and evaluates the surgical protocol for sinus mucosal lining elevation of the maxillary sinus for Dental Implant Insertion without Bone grafting Underneath the Sinus Membrane.
Detailed description
Restoration of lost dentition in the severely atrophic posterior maxilla has for the last 2 decades been successfully treated with various sinus augmentation techniques and installation of dental implants. The use of graft material is anticipated to be necessary; however, recent studies have demonstrated that the mere lifting of the sinus mucosal lining and simultaneous placement of implants result in bone formation. This study was conducted in order to evaluate simultaneous sinus mucosal lining elevation and installation of dental implants without any graft material.
The present study describes and evaluates a modification of the surgical protocol for sinus mucosal lining elevation and simultaneous installation of osseointegrated implants with a MIS implant system (Seven ™) ,in 20 patients.
Preoperative Examination: (Screening):
- Medical History
- Clinical Examination
- Oral hygiene.
- Oral mucosa condition.
- Number of missing teeth in the posterior maxilla.
- Radiographic Examination (CT and Panoramic X-ray)
- Sinus Maxillary condition.
- Sub-antral bone height.
- Bone jaw condition. Selected patients under the "inclusion criteria" will be included in the study after they will have explanation and signed on informed consent.
Surgery:
All patients will be operated on under local anesthesia (2% Xylocaine Dental with epinephrine 1:100,000;) or General anesthesia ( the type of the anesthesia will be decided by the patients) at Carmel medical center Haifa.. Preoperative antibiotics will orally administered 45 minutes before surgery; patients routinely received 2 g of Augmentin or 600 mg of clindamycin (when allergic to penicillin).and 6mg of Dexamethasone 1 hour before surgery.
Surgical Technique:
The posterior maxillary edentulous area and the maxillary sinus wall will be exposed via a crestal incision and a buccal muco-periosteal flap will be raised. Osteotomy in a oval or rectangular fashion will be made with round Drill 5 mm radius in the anterior wall of the sinus, 5 to 6 mm cranial to the intended implant site (Fig 1). With small sharp elevators the cortical bony window will be pulled in the sinus cavity.
Perforations of various sizes of the sinus mucosal lining will be treated by drilling small holes in the bone above the cortical window to elevate and suture the mucosal lining to that level using absorbable sutures (Vicryl 6-0). If there is success in this technique we will use a small piece of periosteum (taken from the buccal flap) which will be placed as a lid over a perforation of the sinus mucosal lining. If the perforations are so small (less than 1 mm) then further dissection of the mucosal lining and "tenting" by the implants will be considered satisfactory for a blood clot to form around the implants.
After the elevation, implants will be installed in the residual sub-antral bone. The remaining bone height will be recorded with a depth gauge during surgery. Primary implant stability will be noted manually at installation. A stabilizing wrench will be used when removing the implant carrier in all cases.
To achieve implant stability in the cases of small remaining levels of vertical subantral bone, the protocol of installing the MIS system dental implant was modified in its last preparation step. The final conical burr was leveled into the bone 1 to 2 mm less than the recommended standard protocol in cases with only 2 to 3 mm residual bone. Thus, a slightly smaller hole for the implant was prepared and the implant could be placed with better primary stability, utilizing the effect of the conical design and the retention of the microthreads in the superior part, adding an extra effect to the placement and thereby achieving sufficient primary stability. The compartment around the implants under the sinus mucosal lining in the sinus floor will be filled with blood from surrounding bleeding (Fig 2), and dental membrane (Zimmer Ltd.) will be placed on the open window, then the incision will be closed with resorbable sutures (Vicryl 3/0. Ethicon Inc
Postoperative Care:
Analgesics will be prescribed with Optalgin or with a nonsteroidal anti-inflammatory drug for 1 to 2 weeks following the surgery. Antibiotic treatment will be continue for 10 days postoperatively with Augmentin 875mg Twice a day (or clindamycin, 300 mg 3 times daily for penicillin allergic patients). Patients should be instructed not to blow their nose and to use nasal spray saline for 14 days after surgery. Wearing dentures will not be allowed for 10 days following the surgery.
Patients will be reviewed and sutures taken out after 7 to 10 days. Clinical and Radiological Follow-up The patient will be recalled to the out patient clinic in Carmel Medical Center, for a follow up. All patients will be checked in the surgery site and x-ray radiograph will be made.
Radiological follow up:
Periapical radiographs and Panoramic X-ray will be used for measurements of 1) the height of the residual alveolar bone at each implant site, and 2) the height of newly formed bone in the maxillary sinus in relation to each implant. Measurements will be made manually with a millimeter scale. The cervical micro-threaded area of the implant will be used as a reference point during measurement.
Criteria for considering the procedure as successful:
- Successful implants ( no pain, no infection, stable implants) at the uncovering procedure.
- Periapical and panoramic x-ray at the endpoint shows a bone formation around the implant inside the maxillary sinus.
Uncovering of the implant will be done 6 month after the surgery. All patients will be operated on under local anesthesia (2% Xylocaine Dental with epinephrine 1:100,000;) the implant instillation area and the maxillary sinus wall will be exposed via a crestal incision and a buccal mucoperiosteal flap will be raised.
- A healing cap will be inserted in the implant.
- A punch of 2mm biopsy will be take from the maxillary wall. The incision will be closed with resorbable sutures (Vicryl 3/0. Ethicon Inc) around the healing cap.
The referring dentists will carried out the prosthetic rehabilitation after two weeks for the uncovering procedure. All patients will be recalled for follow up after the prosthetic rehabilitation 2 and 4 months in our out patients clinic.
Statistics Descriptive statistics will be used and the correlation of results will be confirmed with linear regression analysis.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (women, men) with a range of a age 18-65 years will be consecutively included. The patients will be referred to the Department of Oral and Maxillofacial Surgery, Carmel Medical Center, Haifa, for dental implant treatment in the posterior maxilla from every Dental Clinic in Israel
Key inclusion criteria (8 listed)
- Healthy patient.
- Patients that have a rehabilitation dentist.
- Healthy conditions of Maxillary Sinuses and Oral Mucosa.
- Healthy bone determined by Panoramic X-ray.
- Sub-antral bone at least 4 mm as measured on CT.
Key exclusion criteria (6 listed)
- Unhealthy patients, with recorded medical history diseases as: diabetes, mellitus, heart diseases, renal failure, osteoporosis.
- Patients treated with anticoagulation medication (Coumadin, Plavix).
- Patients treated with Oral Bisphosphonate drugs (as Fosalan).
- Patient with a history of Chemotherapy or Radiotherapy treatment.
- Unhealthy conditions of Maxillary Sinuses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CT evaluation before Dental Implant uncovering
Time frame: In the end of the treatment
CT evaluation of bone regeneration
Time frame: In the end of each treatment
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 21 Nov 2013.
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.
Samer Srouji, DMD, Ph.D principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insufficient Bone Volume in Posterior Maxilla, run by Carmel Medical Center at 1 site in Israel.
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 8 inclusion and 6 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 21 Nov 2013. 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 Israel. 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?
CT evaluation before Dental Implant uncovering (time frame: In the end of the treatment). The study lists 2 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 21 Nov 2013; AzTrials last refreshed its copy on 31 Oct 2026.