Implant Stability Using Densah Bur Versus Expander

NCT03613415 | Unknown

• 1 other identifier: Expansion by densah bur
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

evaluating use of Densah bur in thin ridge enhance implant's primary stability when compared to screw expander.

Conditions

Missing Maxillary Premolar

Outcome Measures

Primary Outcomes (5)

• implant's primary stability

  After implant placement, Implant stability will be measured by Ostell device.

  intraoperative at time of surgery

• implant's primary stability

  Implant stability will be measured by Ostell device.

  Implant stability will be measured at second week

• implant's primary stability

  Implant stability will be measured by Ostell device.

  Implant stability will be measured at fourth week

• implant's primary stability

  Implant stability will be measured by Ostell device.

  Implant stability will be measured at sixth week

• implant's primary stability

  Implant stability will be measured by Ostell device.

  Implant stability will be measured at eighth week

Study Arms (2)

Expansion by Densah bur

EXPERIMENTAL

* Scrubbing and draping of the patient in a standard fashion for intra oral procedures followed by local anesthesia administration to the patient. * A mid crestal flap will be reflected. * For both groups the implant manufacturer's pilot drill will be used to perform a standard osteotomy of 10 mm depth. * Sequential use of Densah bur under copious irrigation. * An implant of 3.9\*10 mm will be inserted. * Smart peg will be placed on implant and Osstell will be used to record ISQ. * Healing collars will be placed on implants. * Flap will be prepared for closure and suturing.

Other: Expansion

Expander

ACTIVE COMPARATOR

Scrubbing and draping of the patient in a standard fashion for intra oral procedures followed by local anesthesia administration to the patient. * A mid crestal flap will be reflected. * For both groups the implant manufacturer's pilot drill will be used to perform a standard osteotomy of 10 mm depth. * Sequential use of screw expanders. * An implant of 3.9\*10 mm will be inserted. * Smart peg will be placed on implant and Osstell will be used to record ISQ. * Healing collars will be placed on implants. * Flap will be prepared for closure and suturing.

Other: Expansion

Interventions

Expansion OTHER

non invasive technique to increase thickness of thin ridge

Expander; Expansion by Densah bur

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with partial edentulous maxillary premolar area with crestal thickness ranging from 4 to 6 mm.
• Age 25 - 50 years.
• No intraoral soft tissue or hard tissue pathosis.
• No systemic condition contraindicating implant placement.

You may not qualify if:

• Ridges thickness less than 4 mm.
• Coexisting vertical defect.
• Heavy smokers (more than 20 cigarettes per day).
• Patients with systemic disease that may affect normal healing.
• Patient with psychiatric problems.
• History of radiation therapy to the head and neck region.

Sponsors & Collaborators

• Cairo University: lead

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Central Study Contacts

Ahmed H Mahmoud

CONTACT

00201001029723; ahmedhish14@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: * Each patient will be given a code by the researcher (T.A.) and the observers will be blind to which group this case belong. * Patients, evaluators and statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (doctor)

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 3, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: February 1, 2020
• Last Updated: August 3, 2018

Record last verified: 2018-07