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

NCT ID: NCT06207578

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-11-01

Brief Summary

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.

Conditions

Implants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Implant placement using crestal sinus approach

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.

Group Type: EXPERIMENTAL

implant placement using crestal sinus approach

Intervention Type: 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

Using Densah bur kit foe osteotomy preparation followed by implant placement

Group Type: ACTIVE_COMPARATOR

Implant placement using osseodensification

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Edentulous atrophic posterior maxillary ridge.

2. Residual alveolar ridge height within 5-6 mm.

3. At least 2mm band of keratinized tissue.

4. Patients with good oral hygiene.

5. Compliant patients to the follow up periods.

Exclusion Criteria

1. Medically compromised patients.

2. Smokers.

3. Pregnant females.

4. Patients with active periodontal disease.

5. Bruxer patients.

6. Patients with chronic or active sinusitis.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Misr International University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abo El Futtouh

Clinical director of implant speciality program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ahmed I Abo El Futtouh, Dr

Role: CONTACT

ahmedkey7@hotmail.com

+201019999983

Inas M El-Zayat, Assoc.Prof

Role: CONTACT

inas.elzayat@gmail.com

+01222361579

Other Identifiers

IDCE.N7

Identifier Type: -

Identifier Source: org_study_id