Clinical trial NCT03445039: Clinical Evaluation of Two Types of Transalveolar Sinus Floor Elevation
Official title: Clinical Evaluation of Modified Transalveolar Sinus Floor Elevation and Osteotome Sinus Floor Elevation in Posterior Maxillae
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implant
Sinus Floor Augmentation
Keywords: Dental implants, Trans-alveolar sinus floor elevation, Bone grafting
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: implant survival rate
timeFrame: the implant status will be inspected and calculated at 1 year revisit
measure: implant stability
timeFrame: 2 weeks after implant placement
measure: implant stability
timeFrame: 4 weeks after the implant placement
measure: implant stability
timeFrame: 8 weeks after the implant placement
measure: implant stability
timeFrame: 12 weeks after the implant placement
measure: implant stability
timeFrame: 16 weeks after the implant placement
measure: implant stability
timeFrame: 26 weeks after the implant placement
measure: implant stability
timeFrame: 52 weeks after the implant placement
measure: marginal bone remodeling around the implant
timeFrame: 26 weeks after the implant placement
measure: marginal bone remodeling around the implant
timeFrame: 52 weeks after the implant placement
measure: post operative pain accessed by the patient
timeFrame: 1 day after the surgery
measure: post operative pain accessed by the patient
timeFrame: 2 days after the surgery
measure: post operative pain accessed by the patient
timeFrame: 3 days after the surgery
measure: post operative pain accessed by the patient
timeFrame: 4 days after the surgery
measure: post operative pain accessed by the patient
timeFrame: 5 days after the surgery
measure: post operative pain accessed by the patient
timeFrame: 6 days after the surgery
measure: post operative pain accessed by the patient
timeFrame: 7 days after the surgery
measure: post operative pain accessed by the patient
timeFrame: 14 days after the surgery
measure: post operative swelling accessed by the patient
timeFrame: 1 day after the surgery
measure: post operative swelling accessed by the patient
timeFrame: 2 days after the surgery
measure: post operative swelling accessed by the patient
timeFrame: 3 days after the surgery
measure: post operative swelling accessed by the patient
timeFrame: 4 days after the surgery
measure: post operative swelling accessed by the patient
timeFrame: 5 days after the surgery
measure: post operative swelling accessed by the patient
timeFrame: 6 days after the surgery
measure: post operative swelling accessed by the patient
timeFrame: 7 days after the surgery
measure: post operative swelling accessed by the patient
timeFrame: 14 days after the surgery
Secondary outcomes:
measure: sulcus bleeding around the implant
timeFrame: 26 weeks after the implant placement
measure: dental plaque around the implant
timeFrame: 26 weeks after the implant placement
measure: other complications
timeFrame: through study completion, up to 1 year
measure: sulcus bleeding around the implant
timeFrame: 52 weeks after the implant placement
measure: dental plaque around the implant
timeFrame: 52 weeks after the implant placement
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University, Hospital of stomatology, the first clinical division
Study officials:
affiliation: Peking University hospital of stomatology, the first clinical division
name: Feng Liu, Dr
role: STUDY_DIRECTOR
References:
citation: Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
citation: Summers RB. The osteotome technique: Part 3--Less invasive methods of elevating the sinus floor. Compendium. 1994 Jun;15(6):698, 700, 702-4 passim; quiz 710.
citation: Lozada JL, Goodacre C, Al-Ardah AJ, Garbacea A. Lateral and crestal bone planing antrostomy: a simplified surgical procedure to reduce the incidence of membrane perforation during maxillary sinus augmentation procedures. J Prosthet Dent. 2011 Mar;105(3):147-53. doi: 10.1016/S0022-3913(11)60020-6.
citation: French D, Nadji N, Shariati B, Hatzimanolakis P, Larjava H. Survival and Success Rates of Dental Implants Placed Using Osteotome Sinus Floor Elevation Without Added Bone Grafting: A Retrospective Study with a Follow-up of up to 10 Years. Int J Periodontics Restorative Dent. 2016;36 Suppl:s89-97. doi: 10.11607/prd.2191.
citation: Tan WC, Lang NP, Zwahlen M, Pjetursson BE. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. Part II: transalveolar technique. J Clin Periodontol. 2008 Sep;35(8 Suppl):241-54. doi: 10.1111/j.1600-051X.2008.01273.x.
citation: Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x.
citation: Markovic A, Misic T, Calvo-Guirado JL, Delgado-Ruiz RA, Janjic B, Abboud M. Two-Center Prospective, Randomized, Clinical, and Radiographic Study Comparing Osteotome Sinus Floor Elevation with or without Bone Graft and Simultaneous Implant Placement. Clin Implant Dent Relat Res. 2016 Oct;18(5):873-882. doi: 10.1111/cid.12373. Epub 2015 Aug 28.
citation: Caban J, Fermergard R, Abtahi J. Long-term evaluation of osteotome sinus floor elevation and simultaneous placement of implants without bone grafts: 10-Year radiographic and clinical follow-up. Clin Implant Dent Relat Res. 2017 Dec;19(6):1023-1033. doi: 10.1111/cid.12530. Epub 2017 Aug 29.
citation: Zhao X, Gao W, Liu F. Clinical evaluation of modified transalveolar sinus floor elevation and osteotome sinus floor elevation in posterior maxillae: study protocol for a randomized controlled trial. Trials. 2018 Sep 14;19(1):489. doi: 10.1186/s13063-018-2879-x.