Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06207578
Enrollment
28
Registered
2024-01-17
Start date
2025-08-01
Completion date
2025-11-01
Last updated
2025-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implants

Keywords

osseodensification, densah bur, Crestal implant approach, closed sinus elevation

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.

Interventions

PROCEDUREimplant 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

PROCEDUREImplant 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.

Sponsors

Misr International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Long- term Implant Stability12 monthsResonance 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

MeasureTime frameDescription
Implant survivability12 monthsIndividual 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
Vertical bone height formed12 monthsusing CBCTs 1
Post operative pain10 dayswill 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

Contacts

Primary ContactAhmed I Abo El Futtouh, Dr
ahmedkey7@hotmail.com+201019999983
Backup ContactInas M El-Zayat, Assoc.Prof
inas.elzayat@gmail.com+01222361579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026