Edentulous Posterior MaxillaNCT01832025
Comparison of Incidence Between Two Techniques
A study testing internal maxillary sinus floor elevation technique and external maxillary sinus floor elevation technique in people with Edentulous Posterior Maxilla, run by Tufts University at 1 site in United States.
Trial summary
Sinus augmentation, also referred to as a sinus lift or a sinus graft, is an oral surgery procedure where bone is added to the upper jaw near the molars. The goal of the surgery is to add enough bone material onto the upper jaw to support the placement of a dental implant. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Posterior Maxilla
- What is being tested?
- internal maxillary sinus floor elevation technique and external maxillary sinus floor elevation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2016
- 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
- 18 years of age or older
- patients treatment planned for sinus lift augmentation and implant placement, with a height of the crestal alveolar bone measured in the middle of the edentulous space between four and six mm (calibrated measurements recorded on existing panoramic radiograph)
- the length of the edentulous span is one or two teeth
- non-smokers
Who cannot join
- patients who have had a previous sinus lift augmentation procedure
- pathology present within the sinus (sinusitis, polyps, neoplasia, mucoceles, etc.) or any deformity/radiation therapy to the sinus
- medically compromised patients contraindicated to dental surgery at TUSDM periodontal clinic including uncontrolled diabetes (HbA1c ≥7, lab results from within the past 6 months will be reviewed, patient without lab results from within the past 6 months will be excluded) and/or uncontrolled hypertension (more than stage II, ≥160/110)
- patients with medical condition that could potentially affect wound healing (e.g., self-reported Hepatitis B or C, self-reported HIV)
- patients with metabolic bone disease such as Paget's Disease or osteoporosis
- patients who are currently taking bisphosphonates or steroids
- patients who are currently pregnant according to self-report (standard of care in the TUSDM Periodontology clinic for such procedures)
- current smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
Official title: Comparison of the Intraoperative, Postoperative Complications and Patient's Discomfort Involving External and Internal Maxillary Sinus Floor Elevation Techniques With Simultaneous Implant Placement: a Randomized Clinical Trial
Sinus augmentation, also referred to as a sinus lift or a sinus graft, is an oral surgery procedure where bone is added to the upper jaw near the molars. The goal of the surgery is to add enough bone material onto the upper jaw to support the placement of a dental implant. The augmentation and the dental implant placement will be done at the same time to avoid the need for two surgeries. This is standard of care.
The purpose of this study is to compare any problems and patient comfort levels following surgery. Subjects will be randomly placed into one of two groups: the internal lift group or the external lift group. Both types of surgery are routinely done at our clinic. Usually the type of procedure (internal or external) is based on the dentist's preference. Investigators are doing this study to compare them to each other to see if one is more comfortable for the subject than the other or if they are equal. It is predicted that the two techniques may differ when it comes to complications during the procedure, patient discomfort following the procedure and patient complications in the weeks and months after the procedure. This last comparison has not yet been studied, and surgeons often choose the technique that they prefer from their own experiences. With this research study researchers hope to gain valuable information that will help surgeons' decisions in the future.
- Investigators hypothesize that external sinus augmentation with simultaneous implant placement (external technique) will have a higher rate of Schneiderian membrane perforation than the internal sinus augmentation with simultaneous implant placement (internal technique).
- Investigators hypothesize that the internal technique is associated with more discomfort for the subject compared with the external technique.
- Investigators hypothesize that the external technique will result in more severe pain/bleeding/swelling than the internal technique.
- Investigators hypothesize that the internal technique has a higher incidence of complications that occur between three weeks and three months postoperatively compared with the external technique.
- Investigators hypothesize that the external technique has a higher amount of analgesics taken postoperatively compared with the internal technique
Read the detailed description
Experimental Design
The proposed study design is a single site, double armed, randomized clinical trial. Subjects will be those whose diagnosis requires restoring the lateral maxillary edentulous area by performing sinus augmentation together with implant placement.
Sample Size and Statistical Analysis Sample size A number of 46 subjects, 23 per each group, who meet study inclusion and exclusion criteria, will be treated for this study to allow for a dropout rate of up to 15%. Up to 60 subjects will be consented to reach the research goal of 46.
The sample size was determined using nQuery program (version 7.0) - for a power of 80% with 20 subjects/group, assuming the anticipated values for the Schneiderian membrane rate perforation as 55% (8) for the external procedure and 10% for the internal procedure (9), based on previously reported studies for each procedure.
Randomization Randomization will be performed in a 1:1 ratio using a balanced design based on a computer-generated randomization scheme. A printout of this scheme will be used by the co-investigator which will have the randomization for each subject that qualifies in the order of qualification. Randomization will occur the day of surgery.
Blinding Due to the nature of the procedures, this study will not be blinded.
Subject Characteristics Subjects will include patients whose diagnosis requires restoring the lateral maxillary edentulous area by performing sinus augmentation together with implant placement.
- Conditions
- Edentulous Posterior Maxilla
- Being tested
- internal maxillary sinus floor elevation technique, external maxillary sinus floor elevation technique
- Keywords
- intraoperative, postoperative, complications, discomfort, external, internal, maxillary, elevation, implant, reconstruction, bone, sinus
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internal maxillary sinus floor elevation techniqueProcedure or surgery
The internal lift procedure uses a drilling instrument (a drill that cuts through bone) to break through the bone for where the implant will later go. This creates an opening in the necessary area to allow more bone material to be added, which will move the sinus up and allow for the implant to be securely placed.
external maxillary sinus floor elevation techniqueProcedure or surgery
The external lift procedure involves cutting through the upper-most part of the gums to then cut through the bone to create an opening in the necessary area. The sinus will be manually lifted and the bone material will be added, which will allow for the implant to be securely placed.
| Study group | Role | What they receive |
|---|---|---|
| Internal | Active comparator | internal maxillary sinus floor elevation technique with simultaneous implant placement Receives: Procedure: internal maxillary sinus floor elevation technique |
| External | Active comparator | external maxillary sinus floor elevation technique with simultaneous implant placement Receives: Procedure: external maxillary sinus floor elevation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare incidence of Schneiderian membrane perforation
Compare the incidence of Schneiderian membrane perforation involving sinus augmentation interventions - external and internal technique with simultaneous implant placement.
Measured: 1-3 months after surgical procedure
Secondary outcomes (6)
Compare discomfort
Compare the subject's discomfort during both procedures using a validated survey form filled in by the subject at the end of the procedure.
Measured: 1-3 months after surgical procedure
Compare long term complications
Compare the long term complications that occur after both procedures, evaluated after three weeks and three months. This includes pain, bleeding, swelling or any other adverse events that the subject has experienced related to the procedures being observed.
Measured: 3 weeks to 3 months after surgical procedure
Compare the amount of analgesic taken postoperatively
Compare the amount of analgesic taken postoperatively evaluated using a subject's medication log.
Measured: 1-3 months after surgical procedure
Compare pain
Compare the severity of pain between the two groups, one week after the procedures, using a validated survey.
Measured: 1 week after surgical procedure
Compare Bleeding
Compare the severity of bleeding between the two groups, one week after the procedures, using a validated survey.
Measured: One week after surgical procedure
Compare Swelling
Compare the severity of swelling between the two groups, one week after the procedures, using a validated survey.
Measured: One week after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Hur, DMD MS, Principal investigator, TUSDM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832025
- Sponsor's protocol ID
- TUSDM10665
- Other IDs
- 10665
- Status last verified
- Sep 2018
- First submitted
- 8 Apr 2013
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Intraoperative, Postoperative Complications and Patient's Discomfort Involving External and Internal Maxillary Sinus Floor Elevation Techniques With Simultaneous Implant Placement: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01832025
- Acronym / sponsor ID
- TUSDM10665
- Conditions
- Edentulous Posterior Maxilla
- Keywords
- intraoperative, postoperative, complications, discomfort, external, internal, maxillary, elevation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 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.
Sinus augmentation, also referred to as a sinus lift or a sinus graft, is an oral surgery procedure where bone is added to the upper jaw near the molars. The goal of the surgery is to add enough bone material onto the upper jaw to support the placement of a dental implant. The augmentation and the dental implant placement will be done at the same time to avoid the need for two surgeries. This is standard of care.
The purpose of this study is to compare any problems and patient comfort levels following surgery. Subjects will be randomly placed into one of two groups: the internal lift group or the external lift group. Both types of surgery are routinely done at our clinic. Usually the type of procedure (internal or external) is based on the dentist's preference. Investigators are doing this study to compare them to each other to see if one is more comfortable for the subject than the other or if they are equal. It is predicted that the two techniques may differ when it comes to complications during the procedure, patient discomfort following the procedure and patient complications in the weeks and months after the procedure. This last comparison has not yet been studied, and surgeons often choose the technique that they prefer from their own experiences. With this research study researchers hope to gain valuable information that will help surgeons' decisions in the future.
- Investigators hypothesize that external sinus augmentation with simultaneous implant placement (external technique) will have a higher rate of Schneiderian membrane perforation than the internal sinus augmentation with simultaneous implant placement (internal technique).
- Investigators hypothesize that the internal technique is associated with more discomfort for the subject compared with the external technique.
- Investigators hypothesize that the external technique will result in more severe pain/bleeding/swelling than the internal technique.
- Investigators hypothesize that the internal technique has a higher incidence of complications that occur between three weeks and three months postoperatively compared with the external technique.
- Investigators hypothesize that the external technique has a higher amount of analgesics taken postoperatively compared with the internal technique
Detailed description
Experimental Design
The proposed study design is a single site, double armed, randomized clinical trial. Subjects will be those whose diagnosis requires restoring the lateral maxillary edentulous area by performing sinus augmentation together with implant placement.
Sample Size and Statistical Analysis Sample size A number of 46 subjects, 23 per each group, who meet study inclusion and exclusion criteria, will be treated for this study to allow for a dropout rate of up to 15%. Up to 60 subjects will be consented to reach the research goal of 46.
The sample size was determined using nQuery program (version 7.0) - for a power of 80% with 20 subjects/group, assuming the anticipated values for the Schneiderian membrane rate perforation as 55% (8) for the external procedure and 10% for the internal procedure (9), based on previously reported studies for each procedure.
Randomization Randomization will be performed in a 1:1 ratio using a balanced design based on a computer-generated randomization scheme. A printout of this scheme will be used by the co-investigator which will have the randomization for each subject that qualifies in the order of qualification. Randomization will occur the day of surgery.
Blinding Due to the nature of the procedures, this study will not be blinded.
Subject Characteristics Subjects will include patients whose diagnosis requires restoring the lateral maxillary edentulous area by performing sinus augmentation together with implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal | Active comparator | Procedure: internal maxillary sinus floor elevation techniqueinternal maxillary sinus floor elevation technique with simultaneous implant placement |
| External | Active comparator | Procedure: external maxillary sinus floor elevation techniqueexternal maxillary sinus floor elevation technique with simultaneous implant placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- patients treatment planned for sinus lift augmentation and implant placement, with a height of the crestal alveolar bone measured in the middle of the edentulous space between four and six mm (calibrated measurements recorded on existing panoramic radiograph)
- the length of the edentulous span is one or two teeth
- non-smokers
Key exclusion criteria (8 listed)
- patients who have had a previous sinus lift augmentation procedure
- pathology present within the sinus (sinusitis, polyps, neoplasia, mucoceles, etc.) or any deformity/radiation therapy to the sinus
- medically compromised patients contraindicated to dental surgery at TUSDM periodontal clinic including uncontrolled diabetes (HbA1c ≥7, lab results from within the past 6 months will be reviewed, patient without lab results from within the past 6 months will be excluded) and/or uncontrolled hypertension (more than stage II, ≥160/110)
- patients with medical condition that could potentially affect wound healing (e.g., self-reported Hepatitis B or C, self-reported HIV)
- patients with metabolic bone disease such as Paget's Disease or osteoporosis
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 |
|---|---|---|
| internal maxillary sinus floor elevation techniqueThe internal lift procedure uses a drilling instrument (a drill that cuts through bone) to break through the bone for where the implant will later go. This creates an opening in the necessary area to allow more bone material to be added, which will move the sinus up and allow for the implant to be securely placed. | Procedure or surgery | Internal |
| external maxillary sinus floor elevation techniqueThe external lift procedure involves cutting through the upper-most part of the gums to then cut through the bone to create an opening in the necessary area. The sinus will be manually lifted and the bone material will be added, which will allow for the implant to be securely placed. | Procedure or surgery | External |
Primary outcome
Compare incidence of Schneiderian membrane perforation
Time frame: 1-3 months after surgical procedure
Compare the incidence of Schneiderian membrane perforation involving sinus augmentation interventions - external and internal technique with simultaneous implant placement.
6 secondary outcomes
Compare discomfort
Time frame: 1-3 months after surgical procedure
Compare long term complications
Time frame: 3 weeks to 3 months after surgical procedure
Compare the amount of analgesic taken postoperatively
Time frame: 1-3 months after surgical procedure
Compare pain
Time frame: 1 week after surgical procedure
Compare Bleeding
Time frame: One week after surgical procedure
Compare Swelling
Time frame: One week after surgical procedure
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 24 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Yong Hur, DMD MS principal investigator
TUSDM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internal maxillary sinus floor elevation technique and external maxillary sinus floor elevation technique in people with Edentulous Posterior Maxilla, run by Tufts University at 1 site in United States.
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 8 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 24 Sep 2018. 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 United States. 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?
Compare incidence of Schneiderian membrane perforation (time frame: 1-3 months after surgical procedure). 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 24 Sep 2018.