Densah Burs vs. Electrical Mallet in Closed Sinus Lifting.

Not Applicable

Not yet recruiting

• Conditions: Alveolar Bone Loss
• Interventions: Device: Osseo-densification burs; Device: Electrical mallet

• Registration Number: NCT06180187
• Lead Sponsor: Fayoum University

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.

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Study First Posted: 2023-12-22
• Last Update Posted: 2023-12-22
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osseo-densification group	Osseo-densification burs	-
Electrical mallet group	Electrical mallet	-

Primary Outcome Measures

Name	Time	Method
change in bone density	6 months follow up	Evaluate the amount of change in bone density around dental implant immediately post operative and after 6 months.
bone height gain	6 months follow up	Evaluate the change in bone height radiographically after closed sinus floor elevation and simultaneous implant placement .using cone beam computed tomography immediate after surgery and 6 months post operative .