Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach

Edentulous Jaw Clinical Trial

Official title:

Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04662333
• Other study ID #: CLS001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: December 2020
• Source: University of Siena
• Contact: Nicola D Discepoli, Professor
• Phone: 3392491188
• Email: ndiscepoli[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Edentulous Jaw
• Jaw, Edentulous

Intervention

Procedure:
• Transcrestal approach for sinus lift
After surgical exposure of maxillary alveolar crest, implant site preparation and transcrestal detachment of Schneiderian's membrane will be performed. Thereafter implant will be placed, protruding in the maxillary sinus with its apical part.
• Xenograft application
Before implant placement, xenogenic collagen membrane and bone granules will be pushed under the Schneiderian's membrane through the surgical site.

Locations

Country	Name	City	State
Italy	AOUS	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications rate	amount of complications assessed at patient level	12 months
Secondary	Peri-implant bone stability	the amount (mm) of crestal bone resorption after implant placement assessed through intraoral radiographs	12 months
Secondary	Implant stability quotient	implant stability assessed by resonance frequency analysis	baseline, 1 month, 3 months, 6 months
Secondary	Soft tissue inflammation	percentage of peri-implant soft tissue affected by inflamed connective tissue	6 months