Clinical trial NCT03559777: Primary Stability of Implant in Closed Sinus Lifting Cases Using Densah Bur Versus Osteotome
Official title: Evaluation for Primary Stability of Implant in Closed Sinus Lifting Cases Using Densah Bur Versus Osteotome in Partially Edentulous Patients (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sinus Pneumatization
Keywords: closed sinus lifiting
implant stability
osteotome
densah bur
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomly divided into 2 equal groups
Primary purpose: OTHER

Brief summary: This study is aiming to evaluate primary stability of implant in closed sinus lifting cases by Densah bur in compared to Osteotome in partially edentulous patients hoping that densah bur can lift the sinus membrane and improve primary stability of implant.

Detailed description: The osteotome technique is effective in certain cases, but the most sensitive aspect is the tapping force, which should be sufficient enough to infracture the sinus floor cortical bone but restrained enough to prevent the osteotome tip from traumatizing the Schneiderian membrane.

Several surgical techniques have been proposed to minimize the sinus membrane perforation rate by using a piezosurgical device, balloon, hydrostatic pressure.

The success of therapy in posterior maxilla is not only dependent on the success of the sinus elevation but also the primary stability of the implant that allow bone apposition on the implant surface without any micromovement for osseeointegration.

Later, densah burs are introduced as another treatment option for internal transalveolar approach of sinus floor elevation with improving primary stability of implant by osseodensification.

As treatment options of edentulous maxillary today may include dental implants, the practitioner must be familiar with various sinus lift surgical techniques in order to choose an ideal treatment option for the patient.

Eligibility criteria: Inclusion Criteria:

* Both males as well as females without any active periodontal disease.
* All patients were in a good health with no systemic diseases.
* All selected patients were non-smokers and non-alcoholics.
* Patient were free from T.M.J troubles, abnormal oral habits such as bruxism.
* The edentulous ridges were covered with optimal thickness of soft tissue.
* Remaining natural teeth had good.
* Periodontal tissue support and occlusion showed sufficient inter arch space.
* On the local level, patients with maxillary sinus diseases and unfavorable inter maxillary relationship were excluded.

Exclusion Criteria:

* Patients with residual bone height less than 6mm.
* Patients with systemic disease that may affect bone quality.
* Patients with poor oral hygiene and active periodontal diseases.
* Patient with limited mouth opening.

Primary outcomes:
measure: stability of implant
timeFrame: Implant stability will be measured intraoperative at time of surgery
measure: stability of implant
timeFrame: Implant stability will be measured at second week
measure: stability of implant
timeFrame: Implant stability will be measured at fourth week
measure: stability of implant
timeFrame: Implant stability will be measured at the sixth week
measure: stability of implant
timeFrame: Implant stability will be measured at The eighth week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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