Transcrestal Sinus Lift Using Osseodensification Versus Lateral Window Technique

NCT06126536 | Completed

• 1 other identifier: AUAREC20190100-04
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Implant; Sinus Lifting

Keywords

Osseodensification; Densah Burs; Internal Sinus lifting; External Sinus lifting

Outcome Measures

Primary Outcomes (1)

• Bone height gain

  In Millimeter(mm)

  Immediate post-operative, 6 Months post-operative

Secondary Outcomes (3)

• Ridge height

  Immediate post-operative, 6 Months post-operative

• Implant stability

  Immediate post-operative, 6 Months post-operative

• Bone Density

  Immediate post-operative, 6 Months post-operative

Study Arms (2)

Group 1: Crestal Maxillary Sinus Floor Elevation using Osseodensification:

EXPERIMENTAL

A crestal incision will be made towards the palate for better wound closure. A conservative flap will be raised, extending beyond the alveolar crest to minimize complications. In cases with 4-6mm ridge height and a need for 3mm vertical depth, a narrow densifying bur will be used, followed by wider burs to elevate the sinus membrane. The Densah® Bur will compact graft material to lift the membrane without penetrating the sinus floor. The osteotomy will be filled with bone graft substitute, and the final bur will apically propel the graft for vertical augmentation. Implant placement follows confirmation via radiography.

Procedure: Crestal Maxillary Sinus Floor Elevation using Osseodensification

Group 2: Lateral Maxillary Sinus Floor Elevation

EXPERIMENTAL

In the Lateral technique, a crestal incision and mucoperiosteal flap will expose the sinus's lateral wall. A bony window is created, and when removable, sinus elevation curettes are used to elevate the sinus floor cautiously. Membrane perforations are covered with a resorbable collagen membrane if needed. Implant osteotomies follow standard protocol. Graft material mixed with saline is gently packed into the sinus to achieve the desired bone height. A resorbable membrane is placed on the window's outer surface, and the flap is sutured for primary closure.

Procedure: Lateral Maxillary Sinus Floor Elevation

Interventions

Crestal Maxillary Sinus Floor Elevation using Osseodensification PROCEDURE

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.

Group 1: Crestal Maxillary Sinus Floor Elevation using Osseodensification:

Lateral Maxillary Sinus Floor Elevation PROCEDURE

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.

Group 2: Lateral Maxillary Sinus Floor Elevation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Sinus pathology that precludes routine sinus augmentation.
• All contraindications of dental implants.11,12
• Heavy smokers.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Dental Medicine - Al-Azhar University

Asyut, Egypt

Location

Related Publications (10)

• 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.

  PMID: 28254402 BACKGROUND

• 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.

  PMID: 18724852 BACKGROUND

• 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.

  PMID: 19885447 BACKGROUND

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

  PMID: 19885448 BACKGROUND

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

  PMID: 9759033 BACKGROUND

• 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.

  PMID: 31367919 BACKGROUND

• 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.

  PMID: 19681937 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 30427961 BACKGROUND

• 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.

  PMID: 27741329 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: December 7, 2019
• Primary Completion: March 13, 2022
• Study Completion: March 13, 2022
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

EG (1)