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Alveolar Ridges Expansion Using Osseodensification Versus Screw Expansion Technique

Primary Purpose

Dental Implant Failed, Bone Fracture, Bone Infection

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Screw expander
Osseodensification drills
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Implant Failed focused on measuring Dental implant stability, narrow alveolar ridges, alveolar ridge expansion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Patient's age ≥18 years. Absence of any medical disease that compromise wound healing. patient with good oral hygiene. 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.

Sites / Locations

  • college of dentistry/University of Baghdad

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Screw expansion group

Osseodensification group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
Alveolar ridge thickness
Alveolar bone thickness was measured after osteotomy site preparation.

Secondary Outcome Measures

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.

Full Information

First Posted
May 15, 2023
Last Updated
June 9, 2023
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT05895903
Brief Title
Alveolar Ridges Expansion Using Osseodensification Versus Screw Expansion Technique
Official Title
Evaluation of Dental Implant Stability in Narrow Alveolar Ridges Utilizing Osseodensification Technique Versus Screw Expansion: A Comparative Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
January 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implant Failed, Bone Fracture, Bone Infection
Keywords
Dental implant stability, narrow alveolar ridges, alveolar ridge expansion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigator
Masking Description
A randomized allocation sequence created using GraphPad Prism 9 software divided the patients in two groups.
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screw expansion group
Arm Type
Active Comparator
Arm Description
threadform screw expanders with special condensing burs for lateralization and compaction of bone while simultaneously placing dental implants
Arm Title
Osseodensification group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Screw expander
Other Intervention Name(s)
Threads expander
Intervention Description
threadform screw expanders with special condensing burs for lateralization and compaction of bone
Intervention Type
Device
Intervention Name(s)
Osseodensification drills
Other Intervention Name(s)
Densah burs
Intervention Description
special drills to expand narrow alveolar ridges.
Primary Outcome Measure Information:
Title
Primary stability
Description
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.
Time Frame
At the time of surgery
Title
Alveolar ridge thickness
Description
Alveolar bone thickness was measured after osteotomy site preparation.
Time Frame
At the time of surgery
Secondary Outcome Measure Information:
Title
secondary stability
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Patient's age ≥18 years. Absence of any medical disease that compromise wound healing. patient with good oral hygiene. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NAWFAL HASAN ABBAS, B.D.S
Organizational Affiliation
Baghdad university/College of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
college of dentistry/University of Baghdad
City
Baghdad
Country
Iraq

12. IPD Sharing Statement

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Alveolar Ridges Expansion Using Osseodensification Versus Screw Expansion Technique

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