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NCT Number: NCT06207578

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

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.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

implant placement using crestal sinus approach

Procedure

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

Implant placement using osseodensification

Procedure

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 outcomes

  1. Long- term Implant Stability

    Time frame: 12 months

    Resonance frequency analysis will be employed with a dedicated device (Osstell). For each implant, implant stability quotient ISQ values will measured from the four sites (mesial, distal, buccal, and palatal sites). The mean of all measurements will be rounded to a whole number and regarded as the final ISQ of the implant. ISQ values will obtained after implant placement (T1), after loading (T2), 6 months after loading (T3) follow up intervals.

Secondary outcomes

  1. Implant survivability

    Time frame: 12 months

    Individual unattached implant that is immobile when tested clinically, radiography that does not demonstrate evidence of peri-implant radiolucency, Bone loss that is less than 0.2 mm annually after the implant's first year of service, No persistent pain, discomfort or infection

  2. Vertical bone height formed

    Time frame: 12 months

    using CBCTs 1

  3. Post operative pain

    Time frame: 10 days

    will be recorded by the patient for 10 days after the surgery The patients will mark the pain perception in a non-numerical 100 mm line ranging from "no pain=0" (left) to "very painful=100" (right). It will be given a numerical value by measuring in millimeters the distance from the left end of the line

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed I Abo El Futtouh, Dr

CONTACT

[email protected]

+201019999983

Inas M El-Zayat, Assoc.Prof

CONTACT

[email protected]

+01222361579

Sponsors and collaborators

Lead sponsor

Misr International University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2024
Registry last updated
Apr 18, 2025

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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