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Histomorphometric and Tomographic Assessment on the Influence of the Placement of a Collagen Membrane Subjacent the Sinus Mucosa After Maxillary Sinus Floor Augmentation

A

ARDEC Academy

Status

Completed

Conditions

Alveolar Bone Loss

Treatments

Procedure: Maxillary sinus augmentation

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT03902457
CBCT sinus membrane

Details and patient eligibility

About

the purpose of the study is to look for differences in dimensional variations of augmented maxillary sinuses with or without the placement of a collagen membrane subjacent the sinus mucosa.

Full description

Material and Methods: After the elevation of the maxillary sinus mucosa, a collagen membrane with standard dimensions will be placed at the test sites subjacent the sinus mucosa and the elevated space will be filled with a xenograft, both test and control groups. A collagen membrane will be placed to cover the antrostomy at both groups and sutures will be provided to close the wound. After six months of healing, mini-implants will be installed. After 9 months, biopsies containing the mini-implants will be harvested for histomorphometric analyses. CBCTs will be taken for all patients before surgery (T0), after 1 week from sinus floor augmentation (T1) and after 9 months of healing (T2). Osseointegration of the mini-implants and dimensional changes over time of soft and hard tissues will be evaluated on the CBCTs.

Enrollment

20 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • presence of an edentulous atrophic zone in the posterior segment of the maxilla
  • height of the sinus floor ≤4 mm
  • desiring a prosthetic restoration of the zone using a fix prosthesis supported by implants;
  • ≥ 21 years of age
  • good general health
  • no contraindication for oral surgical procedures
  • not being pregnant

Exclusion criteria

  • present a systemic disordered
  • had a chemotherapic or radiotherapeutic treatment
  • are smokers >10 cigarettes per day
  • have an acute or a chronic sinusitis
  • had a previous bone augmentation procedures in the zone of interest.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

test site
Experimental group
Description:
The sinus mucosa will be elevated and, at the test sites, a collagen membrane will be placed subjacent the sinus mucosa
Treatment:
Procedure: Maxillary sinus augmentation
control site
Experimental group
Description:
The sinus mucosa will be elevated and, at the control sites, a collagen membrane will not be placed subjacent the sinus mucosa
Treatment:
Procedure: Maxillary sinus augmentation

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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