Clinical Evaluation of Two Types of Transalveolar Sinus Floor Elevation

Not Applicable

• Conditions: Sinus Floor Augmentation; Dental Implant
• Interventions: Procedure: bone grafting materials; Device: traditional TSFE; Procedure: without bone grafting materials; Device: TSFE by DASK drills

• Registration Number: NCT03445039
• Lead Sponsor: Peking University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-02
• Study First Submitted: 2018-01-25
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-19
• Last Update Submitted: 2018-02-19
• Study First Posted: 2018-02-26
• Last Update Posted: 2018-02-26
• Primary Completion: 2019-12-25
• Study Completion: 2020-12-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TSFE using osteotomes without bone grafting	without bone grafting materials	The patients in this group will receive transalveolar sinus floor elevation with osteotomes and mallet. The bone substitute will not be placed in this group.The intervention in the arm is the TSFE will be performed by osteotomes.
modified TSFE with bone grafting	bone grafting materials	The patients in this group will receive modified transalveolar sinus floor elevation with the Dask drills. The cortical plate of the sinus floor is grinded or removed by the dome like drills. And the membrane is elevated by the surgical instruments. The bone substitute is placed before the implant placement.Interventions in the arm are bone grafting and the TSFE will be performed by dask drills.
TSFE using osteotomes with bone grafting	bone grafting materials	The patients in this group will receive transalveolar sinus floor elevation with osteotomes and mallet. The bone substitute is placed in this group.The interventions in the arm are bone grafting and the TSFE will be performed by osteotomes.
TSFE using osteotomes with bone grafting	traditional TSFE	The patients in this group will receive transalveolar sinus floor elevation with osteotomes and mallet. The bone substitute is placed in this group.The interventions in the arm are bone grafting and the TSFE will be performed by osteotomes.
TSFE using osteotomes without bone grafting	traditional TSFE	The patients in this group will receive transalveolar sinus floor elevation with osteotomes and mallet. The bone substitute will not be placed in this group.The intervention in the arm is the TSFE will be performed by osteotomes.
modified TSFE with bone grafting	TSFE by DASK drills	The patients in this group will receive modified transalveolar sinus floor elevation with the Dask drills. The cortical plate of the sinus floor is grinded or removed by the dome like drills. And the membrane is elevated by the surgical instruments. The bone substitute is placed before the implant placement.Interventions in the arm are bone grafting and the TSFE will be performed by dask drills.
modified TSFE without bone grafting	TSFE by DASK drills	The patients in this group will receive modified transalveolar sinus floor elevation with the Dask drills. The cortical plate of the sinus floor is grinded or removed by the dome like drills. And the membrane is elevated by the surgical instruments. The bone substitute will not be placed in this group.The intervention in the arm is the TSFE will be performed by dask drills.
modified TSFE without bone grafting	without bone grafting materials	The patients in this group will receive modified transalveolar sinus floor elevation with the Dask drills. The cortical plate of the sinus floor is grinded or removed by the dome like drills. And the membrane is elevated by the surgical instruments. The bone substitute will not be placed in this group.The intervention in the arm is the TSFE will be performed by dask drills.

Primary Outcome Measures

Name	Time	Method
marginal bone remodeling around the implant	52 weeks after the implant placement	use CBCT to access the marginal bone changes between the 52 weeks after the implant placement and baseline (the day the implant is placed).
implant stability	52 weeks after the implant placement	the implant stability is gauged by the RFA( resonance frequency analysis)
post operative swelling accessed by the patient	14 days 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 survival rate	the implant status will be inspected and calculated at 1 year revisit	whether the implant has osseointegrated and functional
post operative pain accessed by the patient	14 days 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.

Secondary Outcome Measures

Name	Time	Method
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	52 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
dental plaque around the implant	52 weeks after the implant placement	measure whether there is dental plaque around the implant

Trial Locations

Locations (1)

Peking University, Hospital of stomatology, the first clinical division; 🇨🇳 Beijing, China