Alveolar Ridges Expansion Using Osseodensification Versus Screw Expansion Technique

NCT ID: NCT05895903

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2023-01-02

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.

Conditions

Dental Implant Failed; Bone Fracture; Bone Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Screw expansion group

threadform screw expanders with special condensing burs for lateralization and compaction of bone while simultaneously placing dental implants

Group Type: ACTIVE_COMPARATOR

Screw expander

Intervention Type: DEVICE

threadform screw expanders with special condensing burs for lateralization and compaction of bone

Osseodensification group

special drills to expand narrow alveolar ridges.These drills share similar advantages with osteotomes in terms of greater tactile sensitivity, faster speed, and low heat generation, all of which help to maintain healthy bone and enhance implant osseointegration.

Group Type: ACTIVE_COMPARATOR

Osseodensification drills

Intervention Type: DEVICE

special drills to expand narrow alveolar ridges.

Interventions

Screw expander

threadform screw expanders with special condensing burs for lateralization and compaction of bone

Intervention Type: DEVICE

Osseodensification drills

special drills to expand narrow alveolar ridges.

Intervention Type: DEVICE

Other Intervention Names

Threads expander; Densah burs

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Nawfal Hasan Abbas Tofan

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

NAWFAL HASAN ABBAS, B.D.S

Role: PRINCIPAL_INVESTIGATOR

Baghdad university/College of Dentistry

Locations

college of dentistry/University of Baghdad

Baghdad, , Iraq

Countries

Iraq

Other Identifiers

07718814

Identifier Type: -

Identifier Source: org_study_id