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Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral.

NCT ID: NCT05804253

Last Updated: 2023-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-06-30

Brief Summary

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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:

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Detailed Description

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Materials and Methods: Thirty maxillary sinuses in 28 participants were initially included and randomly assigned to the test group (TG;DPBM: n=15) or the control group (CG,DBBM: n=15). After a healing period (6 months) bone core biopsies were axially retrieved in the molar site for histological/ histomorphometrical analysis of new bone formations. In addition, radiographically measured graft stability as well as the clinical implant outcome (implant survival/success/peri-implant health) were assessed at the 1-year and 3-year follow-up evaluations.

Conditions

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Histomorphometry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized clinical trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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bovine bone

Patients received maxillary sinus augmentation grafting with bovine bone mineral

Group Type ACTIVE_COMPARATOR

Maxillary sinus augmentation

Intervention Type PROCEDURE

Maxillary sinus grafting with 2 different xenogenic materials

Porcine bone mineral

patients received maxillary sinus augmentation grafting with porcine bone mineral

Group Type ACTIVE_COMPARATOR

Maxillary sinus augmentation

Intervention Type PROCEDURE

Maxillary sinus grafting with 2 different xenogenic materials

Interventions

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Maxillary sinus augmentation

Maxillary sinus grafting with 2 different xenogenic materials

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* drug abuse, additional augmentation procedure, heavy smokers, bisphosphonate abuse
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Camlog Oral Reconstruction Foundation

OTHER

Sponsor Role lead

Responsible Party

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Krennmair Gerald

Univ.Prof.Dr.Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CamlogORF

Identifier Type: -

Identifier Source: org_study_id

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