NCT03077867

Brief Summary

This is set as prospective clinical trial to correlate histologically and radiologically the performance of four different bone grafts (synthetic hydroxyapatite alone, synthetic hydroxyapatite mixed with polylactic-polyglycolic acid, synthetic hydroxyapatite with i-PRF and inorganic bone graft) in the sinus floor elevation technique with lateral approach for the treatment of atrophic crests.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

3.2 years

First QC Date

January 25, 2017

Last Update Submit

March 25, 2021

Conditions

Alveolar Bone Loss

Keywords

sinus liftsynthetic hydroxyapatitebone graft

Outcome Measures

Primary Outcomes (1)

  • comparison of histological performance of the bone grafts

    histomorphometric analysis

    6 months after surgery

Secondary Outcomes (2)

  • implant success

    6 months after surgery

  • comparison of radiological evidence of the bone grafts

    before surgery and 6 months after surgery

Study Arms (4)

test HA

EXPERIMENTAL

synthetic hydroxyapatite alone sinus floor augmentation with bone graft

Procedure: sinus floor augmentation with bone graft

test HA vicryl

EXPERIMENTAL

synthetic hydroxyapatite mixed with polylactic-polyglycolic acid sinus floor augmentation with bone graft

Procedure: sinus floor augmentation with bone graft

test HA-PRF

EXPERIMENTAL

synthetic hydroxyapatite mixed with i-PRF sinus floor augmentation with bone graft

Procedure: sinus floor augmentation with bone graft

control

ACTIVE COMPARATOR

anorganic bovine bone sinus floor augmentation with bone graft

Procedure: sinus floor augmentation with bone graft

Interventions

sinus floor augmentation with bone graftPROCEDURE

sinus floor augmentation with lateral approach with bone graft

Also known as: LASFE
controltest HAtest HA vicryltest HA-PRF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • indications for intervention of sinus lift with lateral approach to allow the insertion of dental implants, based on careful diagnosis and treatment plan;
  • presence of residual bone crest with a height ≤3 mm on the maxillary sinus, at the level of the implant sites planned;
  • the bone crest must be intact (at least 3 months after the loss / extraction of the element corresponding tooth);
  • \) patients must be able to examine and understand the study protocol; 6) informed consent.

You may not qualify if:

  • acute myocardial infarction within the last six months;
  • uncontrolled bleeding disorders;
  • uncontrolled diabetes (HBA1c\> 7.5%);
  • radiation therapy in the district head / neck in the last 24 months;
  • immunocompromised (e.g. HIV infection or chemotherapy in the last three years);
  • current or past treatment with intravenous bisphosphonates;
  • allergy to bovine collagen;
  • psychological or psychiatric diseases;
  • abuse of alcohol or drug use;
  • not controlled periodontal disease;
  • sinus disorders that contraindicate the maxillary sinus lift

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piezosurgery Academy

Parma, 43100, Italy

Location

Related Publications (2)

  • Farina R, Pramstraller M, Franceschetti G, Pramstraller C, Trombelli L. Alveolar ridge dimensions in maxillary posterior sextants: a retrospective comparative study of dentate and edentulous sites using computerized tomography data. Clin Oral Implants Res. 2011 Oct;22(10):1138-1144. doi: 10.1111/j.1600-0501.2010.02087.x. Epub 2011 Feb 15.

    PMID: 21320169BACKGROUND

  • Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent. 2004 Dec;24(6):565-77.

    PMID: 15626319RESULT

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Sinus Floor AugmentationBone Transplantation

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeOrthopedic ProceduresDentistryTissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantation

Study Officials

  • Claudio Stacchi, Dr.

    Piezosurgery Academy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of the International Piezosurgery Academy

Study Record Dates

First Submitted

January 25, 2017

First Posted

March 13, 2017

Study Start

January 15, 2017

Primary Completion

March 15, 2020

Study Completion

March 15, 2021

Last Updated

March 26, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)