Magnetic Mallet and Densah Bur for Crestal Sinus Left

Magnetic Mallet Versus Densah Bur for Crestal Sinus Left With Implant Placement in Maxilla (Randomized Controlled Clinical Trial)

Background: Implant placement in the posterior maxilla is problematic procedure, not only due to inferior properties of bone but also due to loss of vertical bone height, which happens after extraction of posterior teeth. When the required additional height is few millimeters, indirect transcrestal sinus lifting is recommended. Aim: The aim of this study is to evaluate Densah bur versus Magnetic mallet in transcrestal sinus lifting procedure in edentulous molar and premolar maxillary region.

Study Overview

• Status: Recruiting
• Conditions: Maxillary Sinus Left
• Intervention / Treatment: Procedure: Electrical Mallet; Procedure: Densah bur

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Abdelbaset, BDS; Phone Number: 01017900706; Email: mohabdelbaset96@gmail.com

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria Faculty of Dentistry
    • Contact: Mohamed Abdelbaset, BDS; Email: mohabdelbaset96@gmail.com
    • Principal Investigator: mohamed abdelbaset, BDS

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patient seeking replacement of missing maxillary posterior teeth by dental implant procedure.
• Residual bone height is (5-7) mm measured from crestal bone to sinus floor.
• Both genders.
• Good general health;
• Good oral hygiene.

Exclusion Criteria:

• Uncontrolled Diabetes.
• Coagulation disorders.
• Immunological disorders.
• Previous radiation of the head and neck region.
• Presence of chronic systemic diseases;
• Presence of acute or chronic sinus problems;
• Alcohol or drug abuse;
• Heavy smokers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group	Procedure: Densah bur; The implant motor will be adjusted on reverse-densifying mode with 800 to 1200 rpm. According to the desired implant dimension, it will be started with the smallest densah bur. The first densah bur will advanced in densifying mode with bouncing motion in and out movement with copious irrigation until.
Experimental: Test Group	Procedure: Electrical Mallet; The osteotome will be directly attached and pushed by magnetic mallet and a shock wave will be pushed on their tip. The electrical mallet will be imparted to osteotomes a longitudinal movement along a central axis moving up and down toward pilot bone hole providing a driving mechanism of longitudinal movements. Then the sinus lift instruments (Sweden and Martina) will be used to slowly lift the sinus. After that implant will be placed with the help of implant drilling device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain socres	pain will be examined using visual analogue scale (VAS) 0 means no pain 10 means extreme pain	3rd day, 1 week and 10 days
change in implant stability	will be measured by the Resonance Frequency Analysis using osstel	baseline and 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in implant protrusion length	Immediate post- operative CBCT (T1) will be done to measure the implant protrusion length (IPL) which is the length of the implant extending into the maxillary sinus.	baseline and 4 months
change in bone density	it will be measured by CBCT	baseline and 4 months
change in prescence of complications	patients will be followed up to assess the occurence of any clincial complications	3rd day, 1 week and 10 days

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 814-12

Drug and device information, study documents

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