Magnetic Mallet and Densah Bur for Crestal Sinus Left

NCT06677125 | Recruiting

• 1 other identifier: 814-12
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Maxillary Sinus Left

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• change in implant protrusion length

  baseline and 4 months

• change in bone density

  baseline and 4 months

• change in prescence of complications

  3rd day, 1 week and 10 days

Study Arms (2)

Test Group

EXPERIMENTAL

Procedure: Electrical Mallet

Control Group

ACTIVE COMPARATOR

Procedure: Densah bur

Interventions

Electrical Mallet PROCEDURE

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.

Test Group

Densah bur PROCEDURE

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.

Control Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

RECRUITING

Central Study Contacts

Mohamed Abdelbaset, BDS

CONTACT

01017900706; mohabdelbaset96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 6, 2024
• Study Start: January 1, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

EG (1)