NCT04136509

Brief Summary

In this prospective randomized clinical study sinus floor elevation procedures are preformed using different biomaterials with the lateral window technique. After a 6-month healing, at the time of dental implant placement bone core biopsy samples are harvested. The samples undergo micro-Ct and histomorphometric analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

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 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

June 2, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

October 16, 2019

Last Update Submit

June 1, 2023

Conditions

Alveolar Bone LossSinus PneumatizationEdentulous; Alveolar Process, Atrophy

Keywords

cone beam computed tomography (CBCT)microcomputed tomography (micro-CT)histomorphometrysinus floor elevationallograftxenograft

Outcome Measures

Primary Outcomes (2)

  • newly formed bone percentage

    newly formed bone area compared to total area in histomorphometry

    6 months

  • BV/TV bone volume fraction

    bone volume compared to total volume in micro-CT reconstruction

    6 months

Secondary Outcomes (1)

  • bone gain

    3 years

Study Arms (2)

allograft

EXPERIMENTAL

The filler used in sinus floor elevation is albumin impregnated allograft.

Procedure: sinus floor elevationProcedure: bone core biopsyDevice: dental implant placementDiagnostic Test: Cone Beam Computed Tomography scans (CBCT)

xenograft

EXPERIMENTAL

The filler used in sinus floor elevation is anorganic bovine bone mineral.

Procedure: sinus floor elevationProcedure: bone core biopsyDevice: dental implant placementDiagnostic Test: Cone Beam Computed Tomography scans (CBCT)

Interventions

sinus floor elevationPROCEDURE

sinus floor elevation with the lateral technique

Also known as: maxillary sinus augmentation
allograftxenograft
bone core biopsyPROCEDURE

After 6 month healing time reentry took place and bone core biopsy samples were collected from the augmented bone of the maxillary sinuses with a trephine drill. Biopsy samples were collected from the sites where the dental implants were to be placed.

allograftxenograft
dental implant placementDEVICE

During reentry after bone biopsy dental implants were placed.

allograftxenograft
Cone Beam Computed Tomography scans (CBCT)DIAGNOSTIC_TEST

Preoperative CBCT scans are carried out before dental implant placement, 6 months after sinus floor elevations. Postoperative CBCT scans are taken 3 years after sinus floor augmentations.

allograftxenograft

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Periodontally healthy patients
  • Edentulous posterior maxilla

You may not qualify if:

  • History of systemic diseases, that alter bone metabolism (osteoporosis, diabetes mellitus),
  • History of medication known to alter bone remodelling (bisphosphonates, RANK ligand inhibitor monoclonal antibodies, corticosteroids),
  • History of uncontrolled medical or psychiatric disorders,
  • Inflammations of the paranasal sinuses or the alveolar process,
  • History of tumours or irradiation therapy in the head and neck region,
  • Unwillingness to return for follow-ups,
  • Pregnancy,
  • Smoking,
  • Inability to preform proper oral hygiene.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University Department of Community Dentistry

Budapest, 1088, Hungary

Location

MeSH Terms

Conditions

Alveolar Bone LossMouth, EdentulousAtrophy

Interventions

Sinus Floor Augmentation

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeBone TransplantationOrthopedic ProceduresDentistry

Study Officials

  • György Szabó, Md PhD Msc

    Department of Oro-Maxillofacial Surgery and Stomatology Semmelweis University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The specialis tasked with histomorphometric, micro-CT and CBCT analysis has no knowledge on the intervention method.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 23, 2019

Study Start

January 1, 2016

Primary Completion

December 31, 2016

Study Completion

September 1, 2021

Last Updated

June 2, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)