Dental Implant FailedNCT05895903
Alveolar Ridges Expansion Using Osseodensification Versus Screw Expansion Technique
A study testing Screw expander and Osseodensification drills in people with Dental Implant Failed and Bone Fracture, run by University of Baghdad at 1 site in Iraq.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed, Bone Fracture, Bone Infection
- What is being tested?
- Screw expander and Osseodensification drills
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteIraq
- Study dates
- 15 Dec 2021to 2 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 1. Uncontrolled medically compromised patients. 2. Heavy smokers (> 20 cigarettes per day) 3. Patient with parafunctional habits. 4. Local infection at implant site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Dental Implant Stability in Narrow Alveolar Ridges Utilizing Osseodensification Technique Versus Screw Expansion: A Comparative Clinical Study
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.
Read the 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
- Being tested
- Screw expander, Osseodensification drills
- Keywords
- Dental implant stability, narrow alveolar ridges, alveolar ridge expansion
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screw expanderDevice
Also called Threads expander
threadform screw expanders with special condensing burs for lateralization and compaction of bone
Osseodensification drillsDevice
Also called Densah burs
special drills to expand narrow alveolar ridges.
| Study group | Role | What they receive |
|---|---|---|
| Screw expansion group | Active comparator | threadform screw expanders with special condensing burs for lateralization and compaction of bone while simultaneously placing dental implants Receives: 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. Receives: Device: Osseodensification drills |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of surgery
Alveolar ridge thickness
Alveolar bone thickness was measured after osteotomy site preparation.
Measured: At the time of surgery
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start15 Dec 2021
- Primary completion1 Jul 2022
- Study completion2 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nawfal Hasan Abbas Tofan, University of Baghdad
- Investigators
- NAWFAL HASAN ABBAS, B.D.S, Principal investigator, Baghdad university/College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895903
- Sponsor's protocol ID
- 07718814
- Status last verified
- May 2023
- First submitted
- 15 May 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dental Implant Stability in Narrow Alveolar Ridges Utilizing Osseodensification Technique Versus Screw Expansion: A Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT05895903
- Acronym / sponsor ID
- 07718814
- Conditions
- Dental Implant Failed, Bone Fracture, Bone Infection
- Keywords
- Dental implant stability, narrow alveolar ridges, alveolar ridge expansion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 2 Jan 2023 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Screw expansion group | Active comparator | Device: Screw expanderthreadform screw expanders with special condensing burs for lateralization and compaction of bone while simultaneously placing dental implants |
| Osseodensification group | Active comparator | Device: Osseodensification drillsspecial 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 1. Uncontrolled medically compromised patients. 2. Heavy smokers (> 20 cigarettes per day) 3. Patient with parafunctional habits. 4. Local infection at implant site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screw expanderAlso: Threads expanderthreadform screw expanders with special condensing burs for lateralization and compaction of bone | Device | Screw expansion group |
| Osseodensification drillsAlso: Densah bursspecial drills to expand narrow alveolar ridges. | Device | Osseodensification group |
Primary outcome
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.
1 secondary outcome
secondary stability
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NAWFAL HASAN ABBAS, B.D.S principal investigator
Baghdad university/College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screw expander and Osseodensification drills in people with Dental Implant Failed and Bone Fracture, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary stability (time frame: At the time of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.