Clinical trial NCT06180187: Densah Burs vs. Electrical Mallet in Closed Sinus Lifting.
Official title: Radiographic and Clinical Comparative Study Between Osseodensification Burs and Electrical Mallet in Closed Sinus Floor Elevation and Simultaneous Implant Placement. Prospective Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alveolar Bone Loss
Keywords: sinus lift
electrical mallet
osseodensification
bone density
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group I (Osseo Densification group) Patients in this group will have sinus floor elevation using osseodensification burs then application of PRF membrane through the socket to protect schneiderian membrane and application of sticky bone (xeno graft and i-PRF) to augment alveolar ridge to receive dental implant

group II (electrical mallet group) Patients in this group will have sinus floor elevation using electrical mallet then application of PRF membrane through the socket to protect schneiderian membrane and application of sticky bone (xeno graft and i-PRF) to augment alveolar ridge to receive dental implant
Primary purpose: TREATMENT

Brief summary: The aim of the comparative study is to evaluate the density and amount of new bone formed (bone height gain)around dental implant placed simultaneously in posterior maxilla after closed sinus floor elevation using Osseodensification burs versus electrical mallet.

Detailed description: Extraction of posterior teeth in the maxilla for long time without rehabilitation of the area increases the incidence of maxillary sinus pneumatization that makes maxillary sinus enlarges in volume over the residual bone of alveolar ridge.

Decreasing the height of sub_ antral bone affects adversely on the bone density which is crucial for implant primary stability causing placement of dental implant quite challenging requiring sinus lifting procedure and bone condensation of residual ridge in addition to bone grafting

Summers technique considered the gold standard for closed sinus floor elevation using osteotome and a hand mallet to condense alveolar bone and elevate schneiderian membrane. One of drawbacks of this technique is benign paroxysmal positional vertigo due to force applied by hand mallet is not controlled.

Electrical mallet was introduced to overcome (BPPV) as it applies controlled force (daN) in short fraction of seconds(µs) with hand piece secured totally by the surgeon and have a wide variety of instruments placed on the hand piece e.g. osteotomes used in sinus floor elevation .

Controlled force of magnetic mallet decrees the risk of schneiderian membrane perforation

Osseodensification burs now show great outcomes in closed sinus lifting procedure.

Densah burs increase the density of alveolar bone which increase the primary stability of dental implants .

Aim of this study is to compare Electrical mallet with Osseodensification burs in closed sinus lifting.

Eligibility criteria: Inclusion Criteria:

* patients with partially edentulous posterior maxilla
* Residual bone height ≥ 5mm
* Oral hygiene : fair oral hygiene

Exclusion Criteria:

* Smoking
* Systematic disease that affects bone remodeling (e.g. uncontrolled Diabetes mellitus or osteoporosis)
* Radiotherapy to head and neck or chemotherapy
* Chronic disease of maxillary sinus

Primary outcomes:
measure: bone height gain
timeFrame: 6 months follow up
measure: change in bone density
timeFrame: 6 months follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: