Transcrestal Sinus Lift Using Osseodensification Versus Lateral Window Technique

Dental Implant Clinical Trial

Official title:

Transcrestal Sinus Lift Using Osseodensification Versus Lateral Window Technique With Simultaneous Implant Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06126536
• Other study ID #: AUAREC20190100-04
• Status: Completed
• Phase: N/A
• Start date: December 7, 2019
• Est. completion date: March 13, 2022

Study information

• Verified date: November 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the transcrestal sinus lift using Osseodensification versus lateral window technique with simultaneous implant placement.

Description:

In Group 1, crestal maxillary sinus floor elevation will be done using Osseodensification. An incision will be made near the palate, and a conservative flap will be elevated. Osseodensification burs will be used to create an osteotomy and elevate the sinus membrane gradually. The osteotomy will be filled with bone graft, and the implant will be inserted.

In Group 2, lateral maxillary sinus floor elevation will be performed by creating a bony window in the lateral wall of the sinus. The sinus floor will be carefully elevated using sinus elevation curettes. If there's a membrane perforation, a collagen membrane will be applied. Bone substitute material will be packed into the sinus, and a resorbable membrane will be placed over the window before suturing.

Both groups will use Nanobone as the graft material.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 13, 2022
• Est. primary completion date: March 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with residual bone height from 4-6 mm and bone quality is D3 or D4.

• Patients had to require implant treatment in the posterior maxilla.

• All patients will sign a consent form before the study.

Exclusion Criteria:

• 1- Sinus pathology that precludes routine sinus augmentation.

• All contraindications of dental implants.11,12

• Heavy smokers.

Related Conditions & MeSH terms

• Dental Implant

Intervention

Procedure:
• Crestal Maxillary Sinus Floor Elevation using Osseodensification
Patients will be prepared for surgery with local anesthesia and thorough oral cavity disinfection. A full thickness crestal incision will be made slightly towards the palate to enhance the possibility of achieving primary wound closure. A conservative flap will be raised, extending slightly beyond the alveolar crest, to minimize flap-related issues. After preparing the osteotomy site using Densah burs and elevating the sinus to the desired height, the implant will be inserted into the osteotomy site.
• Lateral Maxillary Sinus Floor Elevation
A crestal incision with an anterior vertical releasing incision exposes the sinus's lateral wall. A mucoperiosteal flap is carefully reflected, revealing the sinus. A bony window is created using a Piezoelectric device, and after elevation, the sinus floor is carefully lifted with various curettes. Implant osteotomies follow standard placement protocol, with precautions against sinus membrane perforation. Nanobone is used as graft material, mixed with saline and gently packed into the sinus. A resorbable membrane is placed on the window's outer surface, secured with circumferential resorbable sutures, and the flap is sutured for closure.

Locations

Country	Name	City	State
Egypt	Faculty of Dental Medicine - Al-Azhar University	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59. — View Citation

Huwais S, Mazor Z, Ioannou AL, Gluckman H, Neiva R. A Multicenter Retrospective Clinical Study with Up-to-5-Year Follow-up Utilizing a Method that Enhances Bone Density and Allows for Transcrestal Sinus Augmentation Through Compaction Grafting. Int J Oral Maxillofac Implants. 2018 Nov/Dec;33(6):1305-1311. doi: 10.11607/jomi.6770. — View Citation

Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14. — View Citation

Jensen SS, Terheyden H. Bone augmentation procedures in localized defects in the alveolar ridge: clinical results with different bone grafts and bone-substitute materials. Int J Oral Maxillofac Implants. 2009;24 Suppl:218-36. — View Citation

Kfir E, Goldstein M, Yerushalmi I, Rafaelov R, Mazor Z, Kfir V, Kaluski E. Minimally invasive antral membrane balloon elevation - results of a multicenter registry. Clin Implant Dent Relat Res. 2009 Oct;11 Suppl 1:e83-91. doi: 10.1111/j.1708-8208.2009.00213.x. Epub 2009 Aug 3. — View Citation

Moraschini V, Uzeda MG, Sartoretto SC, Calasans-Maia MD. Maxillary sinus floor elevation with simultaneous implant placement without grafting materials: a systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2017 May;46(5):636-647. doi: 10.1016/j.ijom.2017.01.021. Epub 2017 Feb 21. — View 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. — View Citation

Suk-Arj P, Wongchuensoontorn C, Taebunpakul P. Evaluation of bone formation following the osteotome sinus floor elevation technique without grafting using cone beam computed tomography: a preliminary study. Int J Implant Dent. 2019 Aug 1;5(1):27. doi: 10.1186/s40729-019-0181-7. — View Citation

Summers RB. Sinus floor elevation with osteotomes. J Esthet Dent. 1998;10(3):164-71. doi: 10.1111/j.1708-8240.1998.tb00352.x. — View Citation

Toffler M, Rosen P. Complications with transcrestal sinus floor elevation: Etiology, prevention, and treatment. In: Froum S (ed). Dental Implant Complications: Etiology, Prevention, and Treatment Hoboken, New Jersey: Wiley, 2015.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone height gain	In Millimeter(mm)	Immediate post-operative, 6 Months post-operative
Secondary	Ridge height	In Millimeter(mm)	Immediate post-operative, 6 Months post-operative
Secondary	Implant stability	In implant stability quotient (ISQ)	Immediate post-operative, 6 Months post-operative
Secondary	Bone Density	In Hounsfield units (HU)	Immediate post-operative, 6 Months post-operative