Osseodensification Drilling TechniqueOD CW CCW PSNCT07912489
Effectiveness of Clockwise vs. Counter-Clockwise Osseodensification for Implant Site Preparation
A study testing Clockwise Cutting with Densah Burs and Counter-Clockwise Osseodensification with Densah Burs in people with Osseodensification Drilling Technique, run by University of Science and Technology, Yemen at 1 site in Yemen.
Trial summary
This study aims to compare the primary stability of dental implants placed using two different rotational modes of the Densah burs (Clockwise Cutting vs. Counter-Clockwise Osseodensification) under a fully guided protocol. The primary outcomes are peak insertion torque and immediate implant stability quotient (ISQ). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Osseodensification Drilling Technique
- What is being tested?
- Clockwise Cutting with Densah Burs and Counter-Clockwise Osseodensification with Densah Burs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteYemen
- Study dates
- 5 Jan 2026to 15 Nov 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult females aged 18 to 70 years.
- Able to provide written informed consent.
- Clinical indication for two endosseous dental implants at clinically comparable sites in the same participant.
- Edentulous sites (healed or not fully healed) with sufficient bone volume. Minor bone augmentation is permitted only if identical at both paired sites.
- Comparable paired sites regarding jaw, region, and planned implant diameter and length. The same implant dimensions must be used at both sites.
- Bone density corresponding to D2 or D3 (350-1250 HU); dense D1 sites are excluded.
- Good oral hygiene and periodontal stability.
- Adequate inter-arch space and mouth opening for fully guided surgery.
Who cannot join
- Uncontrolled systemic disease.
- Pregnancy or lactation.
- Previous high-dose radiotherapy to the jaws or current chemotherapy.
- Current intravenous antiresorptive therapy (e.g., bisphosphonates).
- Heavy smoking (> 10 cigarettes/day) or substance abuse.
- Severe parafunctional habits.
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- Active infection or untreated periodontitis at the planned sites.
- Sites requiring different grafting procedures between the two sides.
- D1 dense cortical bone or inability to perform the CCW protocol.
- Inability to obtain two comparable eligible sites.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Osseodensification Technique Using Universal Densah Burs for Implant Site Preparation : Clinical Study
This study aims to compare the primary stability of dental implants placed using two different rotational modes of the Densah burs (Clockwise Cutting vs. Counter-Clockwise Osseodensification) under a fully guided protocol. The primary outcomes are peak insertion torque and immediate implant stability quotient (ISQ).
Read the detailed description
Achieving adequate primary stability in low-density bone remains a clinical challenge. Osseodensification (OD) has been introduced to preserve and compact bone during implant site preparation. Densah burs are unique as they can be operated in two rotational directions: clockwise (CW) for cutting and counter-clockwise (CCW) for densification. However, no randomized human study has directly compared these two modes using the same burs under a fully guided protocol. This study is a prospective, randomized, double-blind, split-mouth controlled clinical trial. Each participant will receive two implants at clinically comparable sites in the same jaw. One site will be prepared using CW cutting mode, and the paired site will be prepared using CCW osseodensification mode. Both interventions will be performed using the same Universal Densah burs, the same fully guided R2GATE surgical guide, and identical implant dimensions to isolate the effect of rotational direction.
The primary outcome is peak insertion torque (IT). Secondary outcomes include immediate implant stability quotient (ISQ) and the correlation between IT and ISQ within each preparation mode. This study will provide the first direct clinical evidence to guide clinicians in selecting the optimal rotational mode for implant site preparation.
- Conditions
- Osseodensification Drilling Technique
- Being tested
- Clockwise Cutting with Densah Burs, Counter-Clockwise Osseodensification with Densah Burs
- Keywords
- Osseodensification, Densah Burs, Primary Stability, ISQ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clockwise Cutting with Densah BursProcedure or surgery
Osteotomy site preparation performed in a clockwise cutting direction using Densah burs following a fully guided protocol
Counter-Clockwise Osseodensification with Densah BursProcedure or surgery
Osteotomy site preparation performed in counter-clockwise direction using Densah burs following a fully guided protocol to achieve osseodensification
| Study group | Role | What they receive |
|---|---|---|
| Osseodensification technique CCW | Active comparator | Not described Receives: Procedure: Counter-Clockwise Osseodensification with Densah Burs |
| Osseodensification technique CW | Experimental | Implant site preparation performed using Densah burs in clockwise cutting direction under a fully guided protocol Receives: Procedure: Clockwise Cutting with Densah Burs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Insertion Torque (IT)
Peak torque required to seat the implant at the planned final position, measured in N/CM using a calibrated surgical motor or a calibrated torque device.
Measured: Immediately at implant placement (intraoperative).
Secondary outcomes (2)
Immediate Implant Stability Quotient (ISQ)
Arithmetic mean of mesial, distal, buccal, and lingual resonance frequency reading measured using the Osstell device. ISQ ranges from 1 to 100, with higher values indicating greater stability.
Measured: Immediately after implant placement (intraoperative).
Correlation between Insertion Torque and Immediate ISQ.
Pearson or Spearman correlation coefficient between insertion torque (N/cm) and mean ISQ within each rotational mode.
Measured: Immediately after implant placement (intraoperative).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start5 Jan 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osseodensification Drilling TechniqueStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Science and Technology, Yemen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yahya Alwani, University of Science and Technology, Yemen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912489
- Sponsor's protocol ID
- 1447/0091/UREC/UST
- Acronym
- OD CW CCW PS
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient confidentiality and privacy, as the dataset contains sensitive clinical information and specific implant coordinates.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Osseodensification Technique Using Universal Densah Burs for Implant Site Preparation : Clinical Study
- ClinicalTrials.gov ID
- NCT07912489
- Acronym / sponsor ID
- OD CW CCW PS / 1447/0091/UREC/UST
- Conditions
- Osseodensification Drilling Technique
- Keywords
- Osseodensification, Densah Burs, Primary Stability, ISQ
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Science and Technology, YemenUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 3 Nov 2026 (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.
This study aims to compare the primary stability of dental implants placed using two different rotational modes of the Densah burs (Clockwise Cutting vs. Counter-Clockwise Osseodensification) under a fully guided protocol. The primary outcomes are peak insertion torque and immediate implant stability quotient (ISQ).
Detailed description
Achieving adequate primary stability in low-density bone remains a clinical challenge. Osseodensification (OD) has been introduced to preserve and compact bone during implant site preparation. Densah burs are unique as they can be operated in two rotational directions: clockwise (CW) for cutting and counter-clockwise (CCW) for densification. However, no randomized human study has directly compared these two modes using the same burs under a fully guided protocol. This study is a prospective, randomized, double-blind, split-mouth controlled clinical trial. Each participant will receive two implants at clinically comparable sites in the same jaw. One site will be prepared using CW cutting mode, and the paired site will be prepared using CCW osseodensification mode. Both interventions will be performed using the same Universal Densah burs, the same fully guided R2GATE surgical guide, and identical implant dimensions to isolate the effect of rotational direction.
The primary outcome is peak insertion torque (IT). Secondary outcomes include immediate implant stability quotient (ISQ) and the correlation between IT and ISQ within each preparation mode. This study will provide the first direct clinical evidence to guide clinicians in selecting the optimal rotational mode for implant site preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osseodensification technique CCW | Active comparator | Procedure: Counter-Clockwise Osseodensification with Densah Burs |
| Osseodensification technique CW | Experimental | Procedure: Clockwise Cutting with Densah BursImplant site preparation performed using Densah burs in clockwise cutting direction under a fully guided protocol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult females aged 18 to 70 years.
- Able to provide written informed consent.
- Clinical indication for two endosseous dental implants at clinically comparable sites in the same participant.
- Edentulous sites (healed or not fully healed) with sufficient bone volume. Minor bone augmentation is permitted only if identical at both paired sites.
- Comparable paired sites regarding jaw, region, and planned implant diameter and length. The same implant dimensions must be used at both sites.
Key exclusion criteria (10 listed)
- Uncontrolled systemic disease.
- Pregnancy or lactation.
- Previous high-dose radiotherapy to the jaws or current chemotherapy.
- Current intravenous antiresorptive therapy (e.g., bisphosphonates).
- Heavy smoking (> 10 cigarettes/day) or substance abuse.
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 |
|---|---|---|
| Clockwise Cutting with Densah BursOsteotomy site preparation performed in a clockwise cutting direction using Densah burs following a fully guided protocol | Procedure or surgery | Osseodensification technique CW |
| Counter-Clockwise Osseodensification with Densah BursOsteotomy site preparation performed in counter-clockwise direction using Densah burs following a fully guided protocol to achieve osseodensification | Procedure or surgery | Osseodensification technique CCW |
Primary outcome
Peak Insertion Torque (IT)
Time frame: Immediately at implant placement (intraoperative).
Peak torque required to seat the implant at the planned final position, measured in N/CM using a calibrated surgical motor or a calibrated torque device.
2 secondary outcomes
Immediate Implant Stability Quotient (ISQ)
Time frame: Immediately after implant placement (intraoperative).
Correlation between Insertion Torque and Immediate ISQ.
Time frame: Immediately after implant placement (intraoperative).
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 3 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient confidentiality and privacy, as the dataset contains sensitive clinical information and specific implant coordinates.
Related trials for Osseodensification Drilling Technique
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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 Clockwise Cutting with Densah Burs and Counter-Clockwise Osseodensification with Densah Burs in people with Osseodensification Drilling Technique, run by University of Science and Technology, Yemen at 1 site in Yemen.
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 8 inclusion and 10 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 3 Nov 2026. 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 Yemen. 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?
Peak Insertion Torque (IT) (time frame: Immediately at implant placement (intraoperative).). 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 3 Nov 2026.