Primary Stability of Implant in Closed Sinus Lifting Cases Using Densah Bur Versus Osteotome

NCT03559777 | Unknown

• 1 other identifier: closed sinus lifiting
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is aiming to evaluate primary stability of implant in closed sinus lifting cases by Densah bur in compared to Osteotome in partially edentulous patients hoping that densah bur can lift the sinus membrane and improve primary stability of implant.

Conditions

Sinus Pneumatization

Keywords

closed sinus lifiting; implant stability; osteotome; densah bur

Outcome Measures

Primary Outcomes (5)

• stability of implant

  After implant placement, Implant stability will be measured by Ostell

  Implant stability will be measured intraoperative at time of surgery

• stability of implant

  Implant stability will be measured by Ostell

  Implant stability will be measured at second week

• stability of implant

  Implant stability will be measured by Ostell

  Implant stability will be measured at fourth week

• stability of implant

  Implant stability will be measured by Ostell

  Implant stability will be measured at the sixth week

• stability of implant

  Implant stability will be measured by Ostell

  Implant stability will be measured at The eighth week

Study Arms (2)

closed sinus lifting by Osteotome

ACTIVE COMPARATOR

* Local anesthesia will be injected intra-orally * A full thickness flap will be elevated * A pilot drill will be used to start the osteotomy preparation, which should be ended 1mm short of sinus floor. * The widening drills can be sequentially used to widen the osteotomy site to the same level * An osteotome of diameter a little less than the planned implant body, will be inserted in the prepared osteotomy site and gently tapped to reach the same level. * The osteotome will be tapped gently to fracture up the sinus floor. * Xenograft will be added to the osteotomy as the grafting material. * Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted. * Smart peg will be placed on implant and Ostell will be used to record ISQ. * Healing collar will be placed on implant. * Suturing the flab around healing collar.

Other: closed sinus lifting by Osteotome

closed sinus lifting by Densah bur

EXPERIMENTAL

* Local anesthesia will be injected intra-orally * A full thickness flap will be elevated * A pilot drill will be used to start the osteotomy , which should be ended 1mm short of sinus floor. * Change the drill motor to reverse- densifying Mode * Begin with the densah bur (2.5mm) until 1 mm short of the sinus floor. * Use the next wider Densah Bur (3.0) in densifying-mode until feeling the haptic feedback of the bur reaching the dense sinus floor, modulate pressure with a gentle pumping motion to advance past the sinus floor in 1 mm increments. * densah burs (3.5mm) advance in the osteotomy. * Xenograft will be added to the osteotomy . * Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted. * Smart peg will be placed on implant and Ostell will be used to record ISQ. * Healing collar will be placed on implant. * Suturing the flab around healing collar.

Other: closed sinus lifting by Densah bur

Interventions

closed sinus lifting by Osteotome OTHER

* Local anesthesia will be injected intra-orally * A full thickness flap will be elevated * A pilot drill will be used to start the osteotomy preparation, which should be ended 1mm short of sinus floor. * The widening drills can be sequentially used to widen the osteotomy site to the same level * An osteotome of diameter a little less than the planned implant body, will be inserted in the prepared osteotomy site and gently tapped to reach the same level. * The osteotome will be tapped gently to fracture up the sinus floor. * Xenograft will be added to the osteotomy as the grafting material. * Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted. * Smart peg will be placed on implant and Ostell will be used to record ISQ. * Healing collar will be placed on implant. * Suturing the flab around healing collar.

closed sinus lifting by Osteotome

closed sinus lifting by Densah bur OTHER

* Local anesthesia will be injected intra-orally * A full thickness flap will be elevated * A pilot drill will be used to start the osteotomy , which should be ended 1mm short of sinus floor. * Change the drill motor to reverse- densifying Mode * with the densah bur (2.5mm) until 1 mm short of the sinus floor. * Use the next wider Densah Bur (3.0) in densifying-mode until feeling the haptic feedback of the bur reaching the dense sinus floor, modulate pressure with a gentle pumping motion to advance past the sinus floor in 1 mm increments. * densah burs (3.5mm) advance in the osteotomy. * Xenograft will be added to the osteotomy . * Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted. * Smart peg will be placed on implant and Ostell will be used to record ISQ. * Healing collar will be placed on implant. * Suturing the flab around healing collar.

closed sinus lifting by Densah bur

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both males as well as females without any active periodontal disease.
• All patients were in a good health with no systemic diseases.
• All selected patients were non-smokers and non-alcoholics.
• Patient were free from T.M.J troubles, abnormal oral habits such as bruxism.
• The edentulous ridges were covered with optimal thickness of soft tissue.
• Remaining natural teeth had good.
• Periodontal tissue support and occlusion showed sufficient inter arch space.
• On the local level, patients with maxillary sinus diseases and unfavorable inter maxillary relationship were excluded.

You may not qualify if:

• Patients with residual bone height less than 6mm.
• Patients with systemic disease that may affect bone quality.
• Patients with poor oral hygiene and active periodontal diseases.
• Patient with limited mouth opening.

Sponsors & Collaborators

• Cairo University: lead

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  BACKGROUND

Central Study Contacts

taha amer, master

CONTACT

+201095896951; tahaamer181290@gmail.com

ahmed fahmy, professor

CONTACT

+201001029723

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Each patient will be given a code by the researcher and the observers will be blind to which group this case belong.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator(doctor)

Model Details: The patients will be randomly divided into 2 equal groups

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 18, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2019
• Last Updated: June 18, 2018

Record last verified: 2018-06