Alveolar Ridges Expansion Using Osseodensification Versus Screw Expansion Technique

Dental Implant Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05895903
• Other study ID #: 07718814
• Status: Completed
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: January 2, 2023

Study information

• Verified date: May 2023
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

1. Patient's age =18 years.

2. Absence of any medical disease that compromise wound healing.

3. patient with good oral hygiene.

4. Narrow alveolar ridge (2,5-5 mm) and the period after tooth extraction is at least 6 months.

Exclusion Criteria:

• 1. Uncontrolled medically compromised patients. 2. Heavy smokers (> 20 cigarettes per day) 3. Patient with parafunctional habits. 4. Local infection at implant site.

Related Conditions & MeSH terms

• Bone Fracture
• Bone Infection
• Dental Implant Failed
• Fractures, Bone

Intervention

Device:
• Screw expander
threadform screw expanders with special condensing burs for lateralization and compaction of bone
• Osseodensification drills
special drills to expand narrow alveolar ridges.

Locations

Country	Name	City	State
Iraq	college of dentistry/University of Baghdad	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary stability	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.	At the time of surgery
Primary	Alveolar ridge thickness	Alveolar bone thickness was measured after osteotomy site preparation.	At the time of surgery
Secondary	secondary stability	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.	6 months