Tooth AbsenceNCT07244185
Comparison of Osseodensification and Conventional Drilling on the Stability of Tapered and Cylindrical Implants.
A study testing Dental Implant Placement with Osseodensification or Conventional Drilling in people with Tooth Absence, run by Worood Adnan Akram at 1 site in Iraq.
Trial summary
The effect of osseodensification versus conventional implant site preparation on implant stability for tapered and cylindrical dental implants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Absence
- What is being tested?
- Dental Implant Placement with Osseodensification or Conventional Drilling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIraq
- Study dates
- 3 Dec 2024to 11 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 1-Patients who are willing to comply with the study and give their consent. 2-Ability to tolerate conventional surgical and restorative procedure. 3- Healthy patients over 18 years of either gender, having single or multiple missing teeth in the maxilla and/or mandible
Who cannot join
- Active infection or inflammation in implant area or neighboring zone.
- Systemic conditions (medically compromised patient) such as uncontrolled diabetes, coagulation disorders, immune compromised patient, patient treated with bisphosphate drugs, psychiatric problems or unrealistic expectations, pregnant women, any medical condition that affect bone healing.
- Clinical evidence of parafunctional habits.
- Active periodontitis.
- Heavy smokers (≥20 cigarettes a day).
- Advanced and complicated cases.
- Patients who not able to follow the treatment protocol or lost during the study period.
- Patient with history of radiotherapy to the head and neck -
Trial locations and contacts
1 site in 1 country.
Iraq1 site
university of baghdad college of dentistry Teaching hospital
Baghdad, Baghdad Governorate, 10001
About this study
Official title: The Effect of Osseodensification and Conventional Implant Site Preparation on Implant Stability of Tapered and Cylindrical Dental Implants
The effect of osseodensification versus conventional implant site preparation on implant stability for tapered and cylindrical dental implants.
Read the detailed description
Dental implant stability is a key factor influencing the success of osseointegration and the long-term prognosis of implant-supported restorations. The stability of an implant can be divided into two phases: primary stability, which depends on the mechanical engagement between the implant and the surrounding bone at the time of placement, and secondary stability, which develops through biological bone remodeling and osseointegration over time.
Traditional (conventional) drilling techniques used for implant site preparation are subtractive in nature, meaning they remove bone to create space for the implant. However, this process may reduce bone density at the osteotomy walls, particularly in low-density bone, potentially compromising initial stability.
Osseodensification (OD) is a relatively new, non-subtractive drilling technique introduced by Huwais and colleagues. Instead of removing bone, OD uses specially designed, counterclockwise rotating burs (Densah burs) that laterally compact and densify bone along the walls of the osteotomy.
mplant macrodesign-particularly whether the implant is tapered or cylindrical-also influences stability outcomes.
Tapered implants typically provide higher primary stability due to their wedging effect and better adaptation in underprepared osteotomies, especially in soft bone.
Cylindrical implants, while providing more uniform stress distribution, may rely more heavily on bone density and precise site preparation for achieving optimal stability.
- Conditions
- Tooth Absence
- Being tested
- Dental Implant Placement with Osseodensification or Conventional Drilling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implant Placement with Osseodensification or Conventional DrillingProcedure or surgery
Placement of tapered or cylindrical dental implants using osseodensification (bone-compacting technique) or conventional drilling to evaluate implant stability.
| Study group | Role | What they receive |
|---|---|---|
| tapered implant with conventional preparation | Experimental | The osteotomy will be performed following the manufacturer's standard drilling sequence without osseodensification.
This group will serve to evaluate the effect of conventional implant site preparation on the primary and secondary stability of tapered implants Receives: Procedure: Dental Implant Placement with Osseodensification or Conventional Drilling |
| tapered with osseodensification | Experimental | The osteotomy will be prepared with densifying burs operated in a non-subtractive, counterclockwise direction to compact and preserve bone tissue.
This approach aims to enhance bone density and improve the primary and secondary stability of the tapered implants Receives: Procedure: Dental Implant Placement with Osseodensification or Conventional Drilling |
| cylindrical implant with conventional preparation | Experimental | The osteotomy will be performed following the standard sequential drilling protocol recommended by the manufacturer, without applying osseodensification.
This group will be used to assess the effect of conventional implant site preparation on the primary and secondary stability of cylindrical implants Receives: Procedure: Dental Implant Placement with Osseodensification or Conventional Drilling |
| cylindrical with osseodensification | Experimental | The osteotomy will be performed using densifying burs in a non-subtractive, counterclockwise direction, which compacts and preserves the surrounding bone tissue.
This method is intended to increase bone density and improve both primary and secondary implant stability for cylindrical implants Receives: Procedure: Dental Implant Placement with Osseodensification or Conventional Drilling |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary stability
Primary stability refers to the mechanical stability of a dental implant (or any bone implant) immediately after placement, before bone healing or osseointegration occurs.
It mainly depends on bone quality and density, implant design, and surgical technique.it measured using the osstell through Resonance Frequency Analysis,Higher ISQ values indicate greater primary stability.more than 70 ISQ is considerd high stability.
Achieving good primary stability is crucial for implant success, as it helps prevent micromovements and supports proper secondary (biological) stability during healing,
Measured: at the time of surgery
Secondary outcomes (1)
secondary stability
Secondary stability refers to the biological stability of a dental implant that develops over time through osseointegration, the direct structural and functional connection between the implant surface and surrounding bone.
Unlike primary stability, which is mechanical, secondary stability results from bone healing, remodeling, and new bone formation around the implant ..it measured using the osstell through Resonance Frequency Analysis,Higher ISQ values indicate greater stability.more than 70 ISQ is considerd high stability.
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start3 Dec 2024
- Primary completion11 Dec 2025 (estimated)
- Study completion11 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth AbsenceStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Worood Adnan Akram
- Sponsor type
- University, hospital or other
- Collaborators
- Teaching Hospital
- Responsible party
- Sponsor-investigator, Worood Adnan Akram, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244185
- Sponsor's protocol ID
- 974124-2024
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Osseodensification and Conventional Implant Site Preparation on Implant Stability of Tapered and Cylindrical Dental Implants
- ClinicalTrials.gov ID
- NCT07244185
- Acronym / sponsor ID
- 974124-2024
- Conditions
- Tooth Absence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Worood Adnan AkramUniversity, hospital or other
- Collaborators
- Teaching Hospital
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 11 Dec 2025 (estimated)
- Study completion
- 11 Mar 2026 (estimated)
- First posted
- 24 Nov 2025 (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.
The effect of osseodensification versus conventional implant site preparation on implant stability for tapered and cylindrical dental implants.
Detailed description
Dental implant stability is a key factor influencing the success of osseointegration and the long-term prognosis of implant-supported restorations. The stability of an implant can be divided into two phases: primary stability, which depends on the mechanical engagement between the implant and the surrounding bone at the time of placement, and secondary stability, which develops through biological bone remodeling and osseointegration over time.
Traditional (conventional) drilling techniques used for implant site preparation are subtractive in nature, meaning they remove bone to create space for the implant. However, this process may reduce bone density at the osteotomy walls, particularly in low-density bone, potentially compromising initial stability.
Osseodensification (OD) is a relatively new, non-subtractive drilling technique introduced by Huwais and colleagues. Instead of removing bone, OD uses specially designed, counterclockwise rotating burs (Densah burs) that laterally compact and densify bone along the walls of the osteotomy.
mplant macrodesign-particularly whether the implant is tapered or cylindrical-also influences stability outcomes.
Tapered implants typically provide higher primary stability due to their wedging effect and better adaptation in underprepared osteotomies, especially in soft bone.
Cylindrical implants, while providing more uniform stress distribution, may rely more heavily on bone density and precise site preparation for achieving optimal stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tapered implant with conventional preparation | Experimental | Procedure: Dental Implant Placement with Osseodensification or Conventional DrillingThe osteotomy will be performed following the manufacturer's standard drilling sequence without osseodensification. This group will serve to evaluate the effect of conventional implant site preparation on the primary and secondary stability of tapered implants |
| tapered with osseodensification | Experimental | Procedure: Dental Implant Placement with Osseodensification or Conventional DrillingThe osteotomy will be prepared with densifying burs operated in a non-subtractive, counterclockwise direction to compact and preserve bone tissue. This approach aims to enhance bone density and improve the primary and secondary stability of the tapered implants |
| cylindrical implant with conventional preparation | Experimental | Procedure: Dental Implant Placement with Osseodensification or Conventional DrillingThe osteotomy will be performed following the standard sequential drilling protocol recommended by the manufacturer, without applying osseodensification. This group will be used to assess the effect of conventional implant site preparation on the primary and secondary stability of cylindrical implants |
| cylindrical with osseodensification | Experimental | Procedure: Dental Implant Placement with Osseodensification or Conventional DrillingThe osteotomy will be performed using densifying burs in a non-subtractive, counterclockwise direction, which compacts and preserves the surrounding bone tissue. This method is intended to increase bone density and improve both primary and secondary implant stability for cylindrical implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1-Patients who are willing to comply with the study and give their consent. 2-Ability to tolerate conventional surgical and restorative procedure. 3- Healthy patients over 18 years of either gender, having single or multiple missing teeth in the maxilla and/or mandible
Key exclusion criteria (8 listed)
- Active infection or inflammation in implant area or neighboring zone.
- Systemic conditions (medically compromised patient) such as uncontrolled diabetes, coagulation disorders, immune compromised patient, patient treated with bisphosphate drugs, psychiatric problems or unrealistic expectations, pregnant women, any medical condition that affect bone healing.
- Clinical evidence of parafunctional habits.
- Active periodontitis.
- Heavy smokers (≥20 cigarettes a day).
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 |
|---|---|---|
| Dental Implant Placement with Osseodensification or Conventional DrillingPlacement of tapered or cylindrical dental implants using osseodensification (bone-compacting technique) or conventional drilling to evaluate implant stability. | Procedure or surgery | cylindrical implant with conventional preparation, cylindrical with osseodensification, tapered implant with conventional preparation, tapered with osseodensification |
Primary outcome
primary stability
Time frame: at the time of surgery
Primary stability refers to the mechanical stability of a dental implant (or any bone implant) immediately after placement, before bone healing or osseointegration occurs. It mainly depends on bone quality and density, implant design, and surgical technique.it measured using the osstell through Resonance Frequency Analysis,Higher ISQ values indicate greater primary stability.more than 70 ISQ is considerd high stability. Achieving good primary stability is crucial for implant success, as it helps prevent micromovements and supports proper secondary (biological) stability during healing,
1 secondary outcome
secondary stability
Time frame: after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Implant Placement with Osseodensification or Conventional Drilling in people with Tooth Absence, run by Worood Adnan Akram 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 1 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 24 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
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). 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 24 Nov 2025.