Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach

University of Siena

Status: Unknown

Conditions: Edentulous Jaw

Treatments: Procedure: Transcrestal approach for sinus lift; Procedure: Xenograft application

Study type: Interventional

Funder types: Other

Identifiers

NCT04662333

CLS001

Details and patient eligibility

About

Patients in need for implant-supported restoration in maxillary posterior sites with insufficient residual bone height will be randomly allocated to two different arms. Crestal sinus lift with simultaneous implant placement will be performed in both groups.

Control group: crestal sinus lift with no adjunctive biomaterial; Test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; Six months after implant placement, implants will be loaded with definitive screw-retained prostheses.

Six months later, patients will be recalled for clinical and radiographic assessment.

Full description

Patients in need for implant-supported restoration in maxillary posterior sites with bone deficiencies will be randomly allocated to two different arms.

Full-mouth periodontal chart and standardized radiographs will be evaluated at the time of inclusion.

Crestal sinus lift with simultaneous implant placement will be performed in both groups.

Control group: crestal sinus lift with no adjunctive biomaterial; the healing abutment in this group is made up of PEEK (poly-ether-ether-ketone).

Test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; the healing abutment in this group is made up of titanium;

Resonance frequency analysis will be performed at the time of implant placement and at 1, 3, 6 months of follow-up.

Both healing abutment will be undersized: this characteristic will allow to harvest a 1mm-wide biopsy of the transmucosal tract at the end of the healing phase (6 months).

Six months after implant placement, impression will be taken and implants loaded with definitive screw-retained prostheses.

Six months later, patients will be recalled for clinical and radiographic assessment.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• more than 18 years old
• edentulous in posterior maxilla
• patient in need of sinus augmentation procedure
• residual bone height greater than 3mm

Exclusion criteria

• systemic chronic diseases affecting osseointegration
• contraindication for implant therapy
• less than 18 years
• uncontrolled periodontitis
• smoker (more than 10 cig/day)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups

Crestal sinus lift

Active Comparator group

Description:

Implant site preparation with detachment of Schneiderian membrane and subsequent implant placement. The corresponding healing abutment is made up of PEEK (poly-ether-ether-ketone)

Treatment:

Procedure: Transcrestal approach for sinus lift

Crestal sinus lift with adjunctive xenograft

Experimental group

Description:

Implant site preparation with detachment of Schneiderian membrane. After that, collagen membrane plus xenogenic bone substitute will be placed into the site before implant placement. The corresponding healing abutment is made up of titanium.

Treatment:

Procedure: Transcrestal approach for sinus lift

Procedure: Xenograft application