Clinical trial NCT05779345: Stability of Short Implants Versus Standard Blx Implants With Internal Sinus Floor Elevation in Posterior Maxilla
Official title: Clinical and Radiographic Evaluation of Stability of Short Implants Versus Standard Blx Implants Placed With Internal Sinus Floor Elevation in Posterior Maxilla: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Resorption
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Implants in the maxillary posterior region are associated with compromised bone in both quantity - notably in vertical dimension- and quality. Along with the fact that the posterior teeth are subjected to higher occlusal forces than the anterior teeth (Marianne Morand \& Tassos Irinakis, 2007). In order to overcome these shortcomings, various procedures have been advocated including open and closed sinus lift (Nkenke E \& Stelzle F, 2009; Schropp et al, 2003). The use of short implants is a valid alternative for these procedures (Wallace SS \& Froum SJ, 2003) sparing the need of applying augmentation techniques with the associated increased time, morbidity and complexity of such procedures.

Detailed description: To overcome anatomical and physiological limitations, different sinus augmentation techniques with immediate or delayed (6-8 months post augmentation) implant placement have been proposed. The most common one is the sinus elevation with a lateral window approach. Although these protocols evoke a high level of success in augmenting the bone quantity (Nkenke E \& Stelzle F, 2009; Schropp et al, 2003) many patients refuse them because of the invasiveness of the augmentative procedure, with obvious prolonged healing times and increased morbidity and costs (Fugazzotto, 2003; Bra¨gger et al, 2004; Toffler, 2004). An alternative therapy for restoring areas of limited bone dimension is the placement of short implants (Wallace SS \& Froum SJ, 2003). ''Standard length implants'' are those of 10 mm in length and have been defined as the minimal length for anticipated success (Griffin TJ \& Cheung WS, 2004).

Eligibility criteria: Inclusion Criteria:

* Single edentuolous site at maxillary posterior region
* The available bone height below the maxillary sinus should be 7-8mm
* Patients ≥ 20 years old
* Bucco-palatal bone width should be ≥6mm
* Adequate interarch space
* Bounded, single

Exclusion Criteria:

* Patients with local pathological defects related to the area of interest.
* Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.
* Inadequate inter-arch space for implant prosthetic part
* Smokers
* pregnancy

Primary outcomes:
measure: crestal bone level
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Greater Cairo
Study officials:
affiliation: Cairo University
name: Hani El Nahass, Professor
role: STUDY_DIRECTOR
References: