Menu
Not yet recruiting NCT06207578

Implants Placed With Crestal Sinus Approach Versus Osseodensification in Atrophic Posterior Maxilla

No phase Interventional Implants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: implant placement using crestal sinus approach, Implant placement using osseodensification.
Who it may be relevant to
Registry conditions: Implants. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Long Term Stability of Implants Placed With Crestal Sinus Approach Versus Osseodensification in Atrophic Posterior Maxilla. A Randomized Clinical Trial.

Overview

However, recently, most described techniques for posterior atrophic maxillary rehabilitation, are targeting more conservative, cost-effective and efficient methods for sinus elevation eliminating its lateral access. The aim of the present study is to evaluate and compare the long-term implant stability for implants placed by the novel crestal sinus approach versus osseodensification using Densa-bur in Atrophic Posterior Maxilla.

Detailed description

Rehabilitation of the edentulous posterior maxilla using osseointegrated implants is often challenging due alveolar bone resorption, low bone density and maxillary sinus pneumatization. Many protocols were suggested to overcome this phenomenon; placing short implants, 2nd premolar occlusion and finally maxillary sinus elevation.

Maxillary sinus elevation is one of the most common surgical techniques used for increasing the available bone volume to place implants and restore function and esthetics. Sinus elevation was introduced when Boyne and James presented lateral window approach as a modification of the Coldwell Luc technique; the access to lift the sinus floor is performed by a window through the lateral wall. This technique was proven to be effective and successful for sinus elevation even up to 12 mm in cases of severely atrophic ridge. It was later divided into three techniques according to the lateral wall preparation; hinge, elevated and complete.

Lateral approach for sinus lift is usually indicated when residual bone height is less than 5mm. While transcrestal approach can be successfully adopted when residual bone height is at least 5 mm. Osteotome sinus floor elevation was 1st introduced by Summers (1994) and proved to be less invasive, more conservative, less time consuming, and reduces postoperative discomfort to the patient.

Osseodensification is a new surgical technique of biomechanical bone preparation performed for dental implant placement where bone is compacted and autografted into open marrow spaces and osteotomy site walls in outwardly expanding directions. The use of densah burs for preparing implant site had many advantages including the increase of implant bone contact by compaction autografting rather than excavation of bone in conventional drill, this mainly depends on the viscoelastic nature of bone where time dependent stress produces time dependent strain, it also allows for higher insertion torque and increased stability of dental implant.

The use of densah burs for maxillary sinus lifting was first introduced by Huwais and Meyer utilizing the advantages of the osseodensification approach for elevation of the maxillary sinus floor. The idea of compaction autografting supported by the design of densah burs with specially tapered geometry and specially designed flutes to compact the bone on its walls and apex. The idea of this concept is that the special design of flutes in the densifying non cutting mood with counter clockwise motion and presence of irrigation cause a hydraulic wave at the apex of the bur, this wave cause pushing of the sinus membrane upward, also in presence of grafting material cause the same effect and subsequent elevation of the Schneiderian membranewith limited risk of perforation. So this approach is suggested to provide a safe technique for maxillary sinus lifting with limited complications as in osteotome or lateral approach, less perforation and less invasiveness.

Interventions

  • Procedure implant placement using crestal sinus approach
    a Full thickness flap will be elevated at the edentulous site with two vertical releasing incision. After flap reflection, the preparation of osteotomy will be prepared following standard implant system protocol preparation of the osteotomy. Drilling will be done gently till reaching 0-1mm from the sinus floor, then implant placement will take place and the implant itself will be used to gently elevate the sinus up to 3-5mm
  • Procedure Implant placement using osseodensification
    The implant motor will be adjusted on reverse mode with 800 to 1200 rpm. According to the desired implant dimension, Densah bur diameter will be used and then implant placement.

Primary outcome measures

  • Long- term Implant Stability [Time frame: 12 months]
Secondary outcome measures (3)
  • Implant survivability [Time frame: 12 months]
  • Vertical bone height formed [Time frame: 12 months]
  • Post operative pain [Time frame: 10 days]

Eligibility criteria

Inclusion criteria

  • Edentulous atrophic posterior maxillary ridge.
  • Residual alveolar ridge height within 5-6 mm.
  • At least 2mm band of keratinized tissue.
  • Patients with good oral hygiene.
  • Compliant patients to the follow up periods.

Exclusion criteria

  • Medically compromised patients.
  • Smokers.
  • Pregnant females.
  • Patients with active periodontal disease.
  • Bruxer patients.
  • Patients with chronic or active sinusitis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06207578 · IDCE.N7

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗