Dental Implant, Sinus Floor Augmentation
Conditions
Keywords
Dental implants, Trans-alveolar sinus floor elevation, Bone grafting
Brief summary
Background: Implant placement in the posterior maxilla is always troubled by the insufficient bone volume. Trans-alveolar sinus floor elevation (TSFE) has been proven a predictable surgical procedure to increase the bone height in the posterior maxilla. However, questions as the necessity of the bone grafting is necessary during the sinus lift and could the TSFE be performed when the residual bone height is below 5mm are still being debated. Besides, high-quality evidence on comparing the clinical outcome of transalveolar sinus floor elevation with osteotome and modified sinus floor elevation with crestal non-cutting drills is limited. Methods/Design: 120 adult patients who fit the inclusion criterions are being recruited from the first clinical division, School and Hospital of Peking University (Beijing, China). All the patients are assigned into four groups according a table of random numbers. Participants receive 1) TSFE using osteotomes with bone grafting; 2) TSFE using osteotomes without bone grafting; 3) modified TSFE with bone grafting; and 4) modified TSFE without bone grafting. The clinical operators will be concealed with the assignment until the beginning of surgical procedures. In a one year follow up period, implant survival rates, complications, implant stability, bone remodeling around the implant and patient-reported outcome (visual analogue scale for intraoperative discomfort and postoperative pain) are observed and documented. The implant stability is gauged by the resonance frequency analysis for 7 times (2, 4,8,12,16,26,52 weeks). And the bone remodeling is observed and compared by CT scan. Discussion: The result of the trial will support a better decision making in atrophy posterior maxilla when implant placement is needed. If favorable, the use of the modified TSFE would achieve as ideal outcome as the traditional TSFE but with less trauma and postoperative discomforts. Besides, whether the bone graft procedure is necessary for the TSFE will also be discussed.
Interventions
DEVICEtraditional TSFE
The TSFE procedure is performed by osteotomes (Straumann AG, Basel, Switzland) and mallet as the traditional ways.
PROCEDUREbone grafting materials
The bone substitute is placed into the siuns under the membrane before the implant placement
DEVICETSFE by DASK drills
The TSFE procedure is performed by DASK(Dentium Advanced Surgical Kits) drills (Dentium, Korea), the residual cortical plate of the sinus floor is grinded by the drills.
PROCEDUREwithout bone grafting materials
The bone substitute will not be placed into the sinus before the implant placement.
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
All of the patients will be divided into four groups by using randomization tables. The assignment will be concealed from the clinical operators until the beginning of implant surgery. The outcome examiners will be kept blinded to the assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* patients who is more than 18 years old; * patients have lost a single tooth or several teeth in the posterior area of the maxilla, the tooth has/have been extracted for more than three months; * The residual bone height was between 3mm to 6mm; * The width of the alveolar ridge could contain the implant with standard diameter; * The general and local status of patient are suitable for implant placement and sinus floor elevation; * The patient who is willing to sign the informed consent and to follow the experimental follow-up rules.
Exclusion criteria
* Uncontrolled systemic diseases as diabetes, hypertension and so on; * Uncontrolled local diseases as periodontal disease or muco- cutaneous disease; * Heavy smoker (more than 10 cigarettes /day) * Patients who is suffering rhinitis, sinusitis; or rather large cyst is found in the maxillary sinus * The bone density of the maxillary posterior region is too poor to maintain the initial stability of the implant * The target of the implant site once received implant therapy or bone grafting * Patient with psychogenia or incapable to understand and obey the doctors' instruction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post operative swelling accessed by the patient | 1 day after the surgery | The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal No swelling and worst imaginable swelling. The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no swelling anchor and the patient's mark, providing a range of scores from 0-100. |
| implant stability | 2 weeks after implant placement | the implant stability is gauged by the RFA( resonance frequency analysis) |
| marginal bone remodeling around the implant | 26 weeks after the implant placement | use CBCT to access the marginal bone changes between the 26 weeks after the implant placement and baseline (the day the implant is placed). |
| post operative pain accessed by the patient | 1 day after the surgery | The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal No pain and worst imaginable pain. The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. |
| implant survival rate | the implant status will be inspected and calculated at 1 year revisit | whether the implant has osseointegrated and functional |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| dental plaque around the implant | 26 weeks after the implant placement | measure whether there is dental plaque around the implant |
| other complications | through study completion, up to 1 year | including post-operative infection, bleeding in the nostril,hematoma, stuffy nose and benign paroxysmal positional vertigo |
| sulcus bleeding around the implant | 26 weeks after the implant placement | the sulcus bleeding index is used to measure whether there is bleeding when the dental prob is inserte the sulcus around the implant site |
Countries
China
Contacts
Primary ContactXu Zhao, Dr
Backup ContactWei Gao, Dr
Outcome results
None listed