Densah Burs vs. Electrical Mallet in Closed Sinus Lifting.

Radiographic and Clinical Comparative Study Between Osseodensification Burs and Electrical Mallet in Closed Sinus Floor Elevation and Simultaneous Implant Placement. Prospective Clinical Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Device: Osseo-densification burs; Device: 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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: abdelrahman S mostafa; Phone Number: +20 1060641063; Email: as3059@fayoum.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Osseo-densification group	Device: Osseo-densification burs; elevation of the Schneiderian membrane of maxillary sinus using osseodensification burs and place bone graft material to augment the residual alveolar ridge and then place dental implant .
Active Comparator: Electrical mallet group	Device: Electrical mallet; elevation of the Schneiderian membrane of maxillary sinus using electrical mallet and place bone graft material to augment the residual alveolar ridge and then place dental implant .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone height gain	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 .	6 months follow up
change in bone density	Evaluate the amount of change in bone density around dental implant immediately post operative and after 6 months.	6 months follow up

Collaborators and Investigators

• Sponsor: Fayoum University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: bone density; sinus lift; osseodensification; electrical mallet
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: 1222023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No