NCT05804253

Brief Summary

The present study aimed to compare the histomorphometrically evaluated new bone formation, the radiographically measured graft stability and the clinical implant outcome between maxillary sinuses grafted either with deproteinized porcine bone mineral (DPBM) or deproteinized bovine bone mineral (DBBM). Conclusions: From a clinical point of view, the present results demonstrate that DPBM provides for comparable bone formation and stable graft dimension and high implant success rates combined with healthy peri-implant condition:

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

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, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
Last Updated

April 7, 2023

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

March 14, 2023

Last Update Submit

March 26, 2023

Conditions

Histomorphometry

Outcome Measures

Primary Outcomes (1)

  • New bone formation

    Bone trephine specimen retrieved at implant placement were histomorphometrically analyzed. With special interest % of new bone formation,% of residual graft and % of connective tissue were evaluated and compared between bovine and porcine mineral bone used for sinus grafting.

    3 year

Study Arms (2)

bovine bone

ACTIVE COMPARATOR

Patients received maxillary sinus augmentation grafting with bovine bone mineral

Procedure: Maxillary sinus augmentation

Porcine bone mineral

ACTIVE COMPARATOR

patients received maxillary sinus augmentation grafting with porcine bone mineral

Procedure: Maxillary sinus augmentation

Interventions

Maxillary sinus augmentationPROCEDURE

Maxillary sinus grafting with 2 different xenogenic materials

Porcine bone mineralbovine bone

Eligibility Criteria

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

You may qualify if:

  • maxillary sinus atrophy in the need of sinus augmentation, 2 stage augmentation procedure

You may not qualify if:

  • drug abuse, additional augmentation procedure, heavy smokers, bisphosphonate abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sinus Floor Augmentation

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeBone TransplantationOrthopedic ProceduresDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.Prof.Dr.Dr

Study Record Dates

First Submitted

March 14, 2023

First Posted

April 7, 2023

Study Start

January 1, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

April 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share