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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04662333
Other study ID # CLS001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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