Clinical trial NCT06126536: Transcrestal Sinus Lift Using Osseodensification Versus Lateral Window Technique
Official title: Transcrestal Sinus Lift Using Osseodensification Versus Lateral Window Technique With Simultaneous Implant Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Sinus Lifting
Keywords: Osseodensification
Densah Burs
Internal Sinus lifting
External Sinus lifting
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone height gain
timeFrame: Immediate post-operative, 6 Months post-operative
Secondary outcomes:
measure: Ridge height
timeFrame: Immediate post-operative, 6 Months post-operative
measure: Implant stability
timeFrame: Immediate post-operative, 6 Months post-operative
measure: Bone Density
timeFrame: Immediate post-operative, 6 Months post-operative
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Faculty of Dental Medicine - Al-Azhar University
Study officials:
References:
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.
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: 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.
citation: Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.
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.
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.
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.
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.
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.
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.