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RCT With 3 Different Biomaterials for Maxillary Sinus Lift

NCT04506827 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-08-10

No results posted yet for this study

Summary

Background: Lateral maxillary sinus augmentation (MSA) is a predictable bone regeneration technique in case of atrophy of the posterior-upper maxilla. Aimed at obtaining quantity and quality of bone suitable for receiving osseointegrated implants, its success is largely due to the skill of the surgeon, but also to the characteristics of the biomaterial used.

Methods: Twenty-four patients needing MSA were included in the study. The patients were randomly allocated to 3 different groups: Anorganic Bovine Bone Mineral (ABBM) as control, Tricalcium Phosphate (TCP) with or without hyaluronic acid (HA) as test groups. Nine months after MSA bone biopsies were harvested for the histomorphometric analysis. Secondary outcomes were mean bone gain, intraoperative and post-operative complications, implant insertion torque, implant failure and patient related outcome measures (PROMs).

Conditions

  • Alveolar Bone Atrophy

Interventions

PROCEDURE

Maxillary Sinus Augmentation

Biomaterial Graft into the Maxillary Sinus

DEVICE

Maxillary Sinus Graft with ABBM

The maxillary sinuses in the control group are grafted with ABBM

DEVICE

Maxillary Sinus Graft with TCP

The maxillary sinuses in the test1 group are grafted with TCP

DEVICE

Maxillary Sinus Graft with TCP + HA

The maxillary sinuses in the test1 group are grafted with TCP + HA

Sponsors & Collaborators

  • University of Pisa

    lead OTHER

Principal Investigators

  • Nicola A Valente, DDS, MS · University of Seville, Spain

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-23
Primary Completion
2019-06-29
Completion
2019-12-14

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04506827 on ClinicalTrials.gov