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Completed

NCT Number: NCT03899688

Tomographic and Histologic Assessment on the Influence of the Use of a Collagen Membrane to Protect the Antrostomy After Maxillary Sinus Floor Augmentation.

the aim of the present study was to evaluate the dimensional variation and osseointegration of mini-implants at augmented sinus with the antrostomy left unprotected or protected with a collagen membrane.

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Key information

Conditions

Alveolar Bone Loss Alveolar Bone Resorption Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colombia

Cartagena, 5710, Colombia

About this study

The Schneiderian mucosa will be elevated and the created space will be filled with a natural bovine bone grafting material (Cerabone® 1-2 mm, Botiss Biomaterials GmbH). In ten patients randomly selected (control sties), a native collagen membrane made of porcine dermis (Collprotect®, Botiss Biomaterials GmbH) will be placed on the antrostomy. In another ten patients of the test group, the antrostomy will be left without the membrane. The flaps will be sutured and anti-inflammatory drugs and antibiotics will be administrated to the patients. The sutures will be removed after 7 days. After 6 months of healing, two mini-implants with different surface will be installed and retrieved after further 3 months for histomorphometric evaluations.

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) and evaluation of dimensional variations over time of soft and hard tissues will be performed.

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

The patients will be excluded if they 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

Surgical technique for increasing the vertical bone height of the posterior maxilla an antrostomy of about 5 mm in height and 10 mm long will be prepared using a diamond insert mounted on a sonic-air surgical instrument. The Schneiderian membrane will be elevated and clinical measurements will be performed using an UNC 15 probe. The space obtained underneath the sinus mucosa will be filled with the xenograft and a resorbable collagen membrane will be placed to cover the antrostomy only at the randomly selected control sites.

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

    will be assessed in the medial, middle and lateral regions of the elevated zone using the cone beam computerized tomographies

  2. Bone-to-implant contact between the different surfaces and between membrane / no membrane groups

    Time frame: three months of healing

    Measurements of new bone formation will be assessed on the histological images taken from the slides and performed between the most coronal bone contact to the surface and the apex of the mini-implant. Comparisons among test and control (without or with a collagen membrane of the access window) and between the two different surface conformations will be performed

Secondary outcomes

  1. Changing in area of the elevated zone

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

    The area will be delineated by the sinus bone walls and the sinus mucosa. The changes will be evaluated on the cone beam computerized tomographies (CBCTs) taken in various periods.

  2. Bone density

    Time frame: three months of healing

    Measurements of new bone formation will be assessed on the histological images taken from the slides and performed between the most coronal bone contact to the surface and the apex of the mini-implant. Comparisons among test and control (without or with a collagen membrane of the access window) and between the two different surface conformations will be performed.

Sponsors and collaborators

Lead sponsor

ARDEC Academy

Network

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Apr 2, 2019
Registry last updated
Jan 20, 2022

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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