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OpenTrials
Completed

NCT Number: NCT03902457

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colombia

Cartagena, 5710, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maxillary sinus augmentation

Procedure

Maxillary sinus augmentation procedures have become increasingly popular procedures before placement of dental implants in posterior maxillae that have suffered severe bone loss due to sinus pneumatization, alveolar bone atrophy, or trauma.

Other names: maxillary sinus lift, maxillary sinus elevation

Primary outcomes

  1. Changing in height of the elevated zone

    Time frame: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery.

    Measurements will be assessed in the medial, middle and lateral regions of the elevated zone using the cone beam computerized tomographies (CBCTs) taken in various periods.

  2. New bone-to-implant contact

    Time frame: Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing.

    Measurements will be assessed between the most coronal (B) and the most apical (A) contacts of new bone to the implant surface.

Secondary outcomes

  1. Changing in mucosa thickness

    Time frame: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery.

    Measurements will be assessed in the cone beam computerized tomographies (CBCTs) taken in various periods. Comparisons among the CBCTs of each participants will be performed.

  2. New bone density around the mini-implant, from B to A and up to a distance of 400 µm from the implant surface.

    Time frame: Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing

    Measurements will be assessed using a point counting procedure, superposing a lattice with squares of 50 µm over the histological image.

Sponsors and collaborators

Lead sponsor

ARDEC Academy

Network

Collaborators

  • Corporacion Universitaria Rafael Nunez

Registry information

Official study title

Histomorphometric and Cone Beam Computed Tomography Assessments on the Influence a Collagen Membrane Placed Subjacent the Sinus Mucosa After Maxillary Sinus Floor Augmentation. A Randomized Clinical Trial.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2019
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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