Edentulous Posterior Maxilla Clinical Trial
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
| Verified date | September 2018 |
| Source | Tufts University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | December 2016 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Tufts University School of Dental Medicine | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Tufts University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 1-3 months after surgical procedure | |
| Secondary | 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. | 1-3 months after surgical procedure | |
| Secondary | 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. | 3 weeks to 3 months after surgical procedure | |
| Secondary | Compare the amount of analgesic taken postoperatively | Compare the amount of analgesic taken postoperatively evaluated using a subject's medication log. | 1-3 months after surgical procedure | |
| Secondary | Compare pain | Compare the severity of pain between the two groups, one week after the procedures, using a validated survey. | 1 week after surgical procedure | |
| Secondary | Compare Bleeding | Compare the severity of bleeding between the two groups, one week after the procedures, using a validated survey. | One week after surgical procedure | |
| Secondary | Compare Swelling | Compare the severity of swelling between the two groups, one week after the procedures, using a validated survey. | One week after surgical procedure |