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Clinical Trials/NCT05895903
NCT05895903
Completed
Not Applicable

Evaluation of Dental Implant Stability in Narrow Alveolar Ridges Utilizing Osseodensification Technique Versus Screw Expansion: A Comparative Clinical Study

University of Baghdad1 site in 1 country19 target enrollmentDecember 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implant Failed
Sponsor
University of Baghdad
Enrollment
19
Locations
1
Primary Endpoint
Primary stability
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Alveolar ridge expansion is suggested for alveolar crest thicknesses of 3-5 mm. Osseodensification (OD) and screw expansion (SE) techniques have been utilized to expand narrow alveolar ridges (NAR). This study aims to compare the implant stability quotient (ISQ) values of endosteal dental implants (DIs) inserted into NAR via osseodensification versus manual screw expansion.

Detailed Description

This study aimed to evaluate implant primary stability using Densah bur in comparison with screw expander in narrow alveolar ridge. The patient is instructed to gargle with 0.2% chlorhexidine mouthwash, scrubbing the perioral area with 10% povidone iodine and draping the patient head with disposable drapes. The surgery will be performed under local anesthesia using lidocaine hydrochloride 2% with adrenaline 1:8000, the surgical procedure started with flap reflection. A mucoperiosteal elevator was used to reflect the buccal and palatal flaps that were enough to expose the crestal part of alveolar ridge with clear visibility and accessibility. For Expander group: The screw expanders will be use to expand the osteotomy site. The diameters will be use 2.3mm ,2.6 mm, 3 mm, 3.4 mm, 3.8 mm in a successive manner. Each expander will be screw until 10 mm of depth is reached as mark on the expander. Each expanders is gently screwed half turn at a time; to allow slow and gradual expansion of the bone . When necessary, the kit ratchet is used to reach the full depth required. After the use of the final expander, an implant of appropriate size will place. FOR DENSAH BUR GROUP : The Implant motor is set in an anti-clockwise direction and drilling speed is set at 1000 rpm. Densah Burs will use in increasing diameters of 2mm,2.3mm,2.5 mm, 3.0 mm,3.3mm, and 3.5 mm in asuccessive manner and under copious irrigation with sterile saline. When the haptic feedback of the bur is encountered, pressure is modulated by a pumping motion in and out of the osteotomy until 10mm of depth is reached as mark on the bur . After the use of the final expander, an implant of appropriate size will place. For both groups After implant placement, the integrity of the buccal bone will examine for any cracks. The Smart peg\* corresponding with the implant system is placed on the implant and Osstell device is use to measure ISQ from buccal, lingual, mesial, and distal directions. For each side, three reading were taken and an average was calculated. A healing collar will place on the implant, then the flap will approximate and suture around healing collar. Patients is instruct to take an antibiotic after surgery every 24 hours for a week and to start non-steriodal anti-inflammatory drug every 8 hours for 2-3 days; to control the possible post operative pain and edema. Antiseptic mouthwash is also continue 3 times daily for 14 days. The patients will informe with the next appointment date so that the sutures are to be removed after 1 week.

Registry
clinicaltrials.gov
Start Date
December 15, 2021
End Date
January 2, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nawfal Hasan Abbas Tofan

principal investigator

University of Baghdad

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Uncontrolled medically compromised patients.
  • Heavy smokers (\> 20 cigarettes per day)
  • Patient with parafunctional habits.
  • Local infection at implant site.

Outcomes

Primary Outcomes

Primary stability

Time Frame: At the time of surgery

After implant insertion, the multipeg was screwed into the implant fixture, and stability measurement was conducted with the Osstell® ISQ device in two directions (buccolingual and mesiodistal). The mean of these two measurements was recorded as an ISQ value.

Alveolar ridge thickness

Time Frame: At the time of surgery

Alveolar bone thickness was measured after osteotomy site preparation.

Secondary Outcomes

  • secondary stability(6 months)

Study Sites (1)

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