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CompletedNCT05804253Updated Apr 7, 2023

Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral.

An interventional study of Maxillary sinus augmentation in Histomorphometry, sponsored by Camlog Oral Reconstruction Foundation. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-07.

Sponsored by Camlog Oral Reconstruction Foundation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 2 months after the study started (first participant enrolled Jan 2017, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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:

Read the detailed description

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.

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Conditions studied

  • Histomorphometry
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In context

Lead sponsor

This is the only study on the registry with Camlog Oral Reconstruction Foundation as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • drug abuse, additional augmentation procedure, heavy smokers, bisphosphonate abuse
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    bovine bone

    Patients received maxillary sinus augmentation grafting with bovine bone mineral

    Procedure: Maxillary sinus augmentation

  • Active comparator
    Porcine bone mineral

    patients received maxillary sinus augmentation grafting with porcine bone mineral

    Procedure: Maxillary sinus augmentation

Interventions

  • ProcedureMaxillary sinus augmentation

    Maxillary sinus grafting with 2 different xenogenic materials

06

What researchers measure

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.

    Time frame: 3 year

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05804253
Lead sponsor
Camlog Oral Reconstruction Foundation
Responsible party
Krennmair Gerald (Univ.Prof.Dr.Dr, Camlog Oral Reconstruction Foundation) — Principal investigator
First posted
Apr 7, 2023
Start date
Jan 1, 2017
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018
Last update
Apr 7, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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