Alveolar Ridges Expansion Using Osseodensification Versus Screw Expansion Technique

NCT05895903 | Completed

• 1 other identifier: 07718814
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant Failed; Bone Fracture; Bone Infection

Keywords

Dental implant stability; narrow alveolar ridges; alveolar ridge expansion

Outcome Measures

Primary Outcomes (2)

• 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

• Alveolar ridge thickness

  Alveolar bone thickness was measured after osteotomy site preparation.

  At the time of surgery

Secondary Outcomes (1)

• secondary stability

  6 months

Study Arms (2)

Screw expansion group

ACTIVE COMPARATOR

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

Device: Screw expander

Osseodensification group

ACTIVE COMPARATOR

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.

Device: Osseodensification drills

Interventions

Screw expander DEVICE

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

Also known as: Threads expander

Screw expansion group

Osseodensification drills DEVICE

special drills to expand narrow alveolar ridges.

Also known as: Densah burs

Osseodensification group

Eligibility Criteria

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

college of dentistry/University of Baghdad

Baghdad, Iraq

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• NAWFAL HASAN ABBAS, B.D.S

  Baghdad university/College of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: A randomized allocation sequence created using GraphPad Prism 9 software divided the patients in two groups.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Nineteen patients (12 females and 7 males) with narrow alveolar ridges participated in this research. Forty-six osteotomy sites were prepared, and 41 DIs were installed. A randomized allocation sequence created using GraphPad Prism 9 software divided the patients in two groups. The SE technique group consisted of 21 DIs after alveolar bone expansion with threaded screw expander drills, and the OD group consisted of 20 DIs after alveolar ridge expansion with Densah® burs.

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 9, 2023
• Study Start: December 15, 2021
• Primary Completion: July 1, 2022
• Study Completion: January 2, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-05

Locations

IR (1)