Clinical Evaluation of Two Types of Transalveolar Sinus Floor Elevation

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03445039
Study type	Interventional
Source	Peking University
Contact	Xu Zhao, Dr
Phone	086 13331169917
Email	zhaoxu_@hotmail.com
Status	Recruiting
Phase	N/A
Start date	December 2, 2017
Completion date	December 25, 2020

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT05053958` - Using Superimposition of Intra-Oral Scan and CBCT in Single Implant Restorations in Aesthetic Zone.	N/A
Recruiting	`NCT04367766` - Management of the Fresh Extraction Socket in the Aesthetic Area	N/A
Recruiting	`NCT06296459` - Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation	N/A
Not yet recruiting	`NCT05988281` - Success of Implant Restorations After Immediate or Delayed Implant Placement With/Without Ridge Preservation	N/A
Completed	`NCT04340830` - The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants	N/A
Completed	`NCT06404385` - Accuracy of Static Computer-assisted Implant Surgery in Distal Free-end Scenarios	N/A
Recruiting	`NCT05405179` - Simultaneous Dental Implant in Free Vascularized Bone Flaps for Jaw Reconstruction	N/A
Completed	`NCT06138392` - Long-term Study in Early Loaded Hydrophilic Surface Implants
Completed	`NCT04332679` - Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes	N/A
Completed	`NCT06127576` - Biomechanical Informational Effect of Innovative Double or Triple Dental Abutment-implant: Case-series
Recruiting	`NCT06059573` - The Accuracy of Dental Implant Placement Using Robotic System-assisted Surgery and Freehand Surgery	N/A
Recruiting	`NCT06068231` - A Study of Early Loading of Implants in the Maxillary Anterior Region With Alveolar Bone Defects	N/A
Completed	`NCT03774888` - To Compare Different Soft Tissue Grafts at the Time of Lateral Ridge Augmentation Procedure.	N/A
Completed	`NCT02864862` - Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation	Phase 4
Completed	`NCT02444052` - Evaluation of Zimmer Puros® Allograft vs. Creos™ Allograft for Alveolar Ridge Preservation	N/A
Completed	`NCT04861662` - Effect of Keratinized Mucosa on Peri-implant Health	N/A
Not yet recruiting	`NCT04541641` - Clinical Evaluation of Stability of Implants Placed in Partially Edentulous Maxilla With Poor Bone Quality Via New Reverse Drilling Technique Versus Osteotome Technique.	N/A
Completed	`NCT03888339` - Influence of Abutment Shape on Peri-implant Marginal Bone Loss	N/A
Recruiting	`NCT06231134` - Diode Laser 940 nm Versus Electrosurgical Device During Second Stage Implant Surgery on Bone and Soft Tissue Healing	N/A
Enrolling by invitation	`NCT04544839` - Clinical Evaluation of Two Different Attachment System	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.