Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach

December 5, 2020 updated by: Nicola Discepoli, University of Siena

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nicola D Discepoli, Professor
  • Phone Number: 3392491188
  • Email: ndiscepoli@me.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Crestal sinus lift
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)
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.
Experimental: Crestal sinus lift with adjunctive xenograft
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.
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.
Procedure: Xenograft application
Before implant placement, xenogenic collagen membrane and bone granules will be pushed under the Schneiderian's membrane through the surgical site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications rate
Time Frame: 12 months
amount of complications assessed at patient level
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-implant bone stability
Time Frame: 12 months
the amount (mm) of crestal bone resorption after implant placement assessed through intraoral radiographs
12 months
Implant stability quotient
Time Frame: baseline, 1 month, 3 months, 6 months
implant stability assessed by resonance frequency analysis
baseline, 1 month, 3 months, 6 months
Soft tissue inflammation
Time Frame: 6 months
percentage of peri-implant soft tissue affected by inflamed connective tissue
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

November 29, 2020

First Submitted That Met QC Criteria

December 5, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

December 10, 2020

Last Update Submitted That Met QC Criteria

December 5, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLS001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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