Recruiting

NCT Number: NCT06677125

Magnetic Mallet and Densah Bur for Crestal Sinus Left

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.

Recruiting

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Key information

Conditions

Maxillary Sinus Left

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location status: Recruiting

Location contact

Mohamed Abdelbaset, BDS

CONTACT

[email protected]

mohamed abdelbaset, BDS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

Change in pain socres

Time frame: 3rd day, 1 week and 10 days

pain will be examined using visual analogue scale (VAS) 0 means no pain 10 means extreme pain
change in implant stability

Time frame: baseline and 4 months

will be measured by the Resonance Frequency Analysis using osstel

Secondary outcomes

change in implant protrusion length

Time frame: baseline and 4 months

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.
change in bone density

Time frame: baseline and 4 months

it will be measured by CBCT
change in prescence of complications

Time frame: 3rd day, 1 week and 10 days

patients will be followed up to assess the occurence of any clincial complications

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Abdelbaset, BDS

CONTACT

[email protected]

01017900706

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Nov 6, 2024
Registry last updated: Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.