Low Bone DensityNCT07378020
Comparing Between Osseodensification Burs Versus Osteotome in Low Bone Density Areas.
A study testing Conventional Osteotomy, Densah Bur drilling and osteotome bone condensation in people with Low Bone Density, run by Future University in Egypt at 1 site in Egypt.
Trial summary
The objective of this study is to compare the primary stability of implant sites prepared using conventional drilling, osseodensification (Densah bur), and osteotome preparation techniques, and to evaluate the influence of these methods on implant success rates in areas of low bone density. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Low Bone Density
- What is being tested?
- Conventional Osteotomy, Densah Bur drilling and osteotome bone condensation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2024to 15 Dec 2025
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with low bone density (D3), (D4) Missing maxillary posterior teeth
- edentulous ridge should be 8 mm or more of bone height and bone width ≥ 7mm with adequate inter-occlusal space of at least 8mm,
- Patients with good oral hygiene or willing to improve their oral hygiene.
Who cannot join
- Patients with uncontrolled medical conditions that affect Osseo-integration.
- Patients receiving medications that contraindicate osteotomy.
- Heavy smokers.
- History of receiving irradiation in the head and neck region.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Oral and Maxillofacial Department Future Dental Hospital
Cairo, Fifth Settlement, 11835
About this study
Official title: A Comparative Study of Osseodensification Burs Versus Osteotome Preparation on the Stability of Implants Placed in Low Bone Density Areas: a Randomized Controlled Trial
The objective of this study is to compare the primary stability of implant sites prepared using conventional drilling, osseodensification (Densah bur), and osteotome preparation techniques, and to evaluate the influence of these methods on implant success rates in areas of low bone density.
Read the detailed description
in different conditions implants that lack primary stability is subjected to excessive micromotion that can lead to implant failure. This usually happens when dental implants pass the critical limit of micro-motion. Passing this critical limit can interfere with Osseo-integration and cause fibrous encapsulation of dental implant .
Implant Failure usually occurs in completely edentulous maxillae especially in the posterior area where bone quality is compromised.
Clinicians usually refer implants success rates to the difference in bone quality between mandible and maxilla. Higher failure rates seem to be associated with poor bone quality.
Primary stability is affected by several factors including Bone Quantity and quality, the Implant macro- and micro- design, and the used osteotomy technique.
Osteotomies are usually created using conventional drills, although the implant diameter must be slightly larger than the final drill to ensure primary stability However, this conventional drilling technique might be insufficient to provide the primary stability required for Osseo-integration in areas of low bone quality. Several site preparation techniques have been introduced to enhance primary stability in soft bone. Some clinicians used under-sized drilling however the efficiency of this technique is conditioned by decreasing osteotomy diameter by 10% of implant diameter.
Another method introduced by Dr. Robert Summer. This method uses bone condensers to densify bone through the condensation and expansion of spongy bone as it squeezes bone trabeculae laterally against the wall of implant bed at the site of osteotomy increasing the bone density and conserving osseous tissue around implants.
Recently Osseodensification (OD) was introduced as a novel implant site preparation technique that uses specially designed drills with large negative rake angles. When the drills are operated in a counterclockwise direction it acts as a non-cutting drill which is used to expand and compact bone against the osteotomy walls. This non-subtractive approach aims to increase the primary stability of the dental implants inserted into low-density bone compared with conventional drilling techniques. The drills also can be used as a cutting drill when operated in a clockwise direction according to the operator's need. This type of drill can improve bone density leading to improved implant primary stability, giving these drills the ability to cut and densify without the need for additional tools.
Ossoe-densification technique showed greater insertion torques, bone-to implant contact, and bone area fraction occupancy when compared to standard Drilling technique.
this study is comparing between the three different drilling techniques (conventional, osseo-densification, osteotome bone compaction) in enhancing insertion torque and isq values in posterior maxillary area.
the study also compare between the effect of these techniques on marginal bone loss with follow up 6 month after loading using cbct
- Conditions
- Low Bone Density
- Being tested
- Conventional Osteotomy, Densah Bur drilling, osteotome bone condensation
- Keywords
- Osseodensification
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional OsteotomyProcedure or surgery
Also called Subtractive Drilling, Standard Drilling
The implant site will be prepared using a standard sequence of drills (subtractive osteotomy) according to the implant manufacturer's instructions. Drilling will be performed with profuse irrigation at speed between 800-1200 rpm to remove bone and prepare the osteotomy site to the final diameter before implant insertion
Densah Bur drillingProcedure or surgery
Also called Osseodensification, Non-subtractive Drilling
after using the pilot drill in a clockwise direction to drill to the desired depth according to the planned implant length The implant site will be prepared using Densah burs (Versah). the motor is adjusted to rotate in a counter-clockwise direction (densifying mode) at 800-1200 rpm with profuse irrigation. This technique expands the osteotomy site by compacting bone at the periphery rather than removing it, aiming to enhance bone density around the implant then the implant is inserted after reaching the desired diameter according to densah bur soft bone drilling protocol
osteotome bone condensationProcedure or surgery
Also called Manual Bone Condensation, Osteotome Expansion
osteotomy was prepared using (Xive BoneCondensers by dentsply sirona GERMANY) starting from the pilot drill of 1.7mm in diameter to penetrate the cortical bone and gain access. Then instrumentation was done in the following sequence: 2.0mm, 3.0mm, and 3.4mm according to the planned implant diameter. The osteotome was inserted manually and rotated while being pressed towards the apical part of osteotomy till it reaches the full working depth. Once the desired depth was reached, and before moving to the next instrument we wait 1 min for the osteotome to compress and compact the spongy bone. After the implant bed had been prepared, we inserted the implant immediately to avoid any dimensional changes in the site of osteotomy.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Drilling | Active comparator | Implant sites in this arm will undergo osteotomy preparation using standard conventional drilling sequences according to the implant manufacturer's recommendations prior to implant placement Receives: Procedure: Conventional Osteotomy |
| Densah Bur (Osseodensification) | Experimental | Implant sites in this arm will undergo osteotomy preparation using the osseodensification technique with Densah burs (Versah) running in a counter-clockwise direction (densifying mode) prior to implant placement. Receives: Procedure: Densah Bur drilling |
| osteotome | Experimental | Implant sites in this arm will undergo osteotomy preparation using summers osteotome technique for lateral bone condensation and expansion prior to implant placement Receives: Procedure: osteotome bone condensation |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary stability using Insertion Torque Value.
Evaluation of implant stability was done by measuring Insertion torque. Using the surgical contra-angled hand piece the initial torque value was set to10Ncm then increased sequentially by 5Ncm according to the torque required to place the implant at the desired depth. The final torque value used to drive the implant to its position was recorded as the peak insertion torque
Measured: day of surgery
Primary Implant Stability measured through Resonance Frequency Analysis (RFA)
Implant stability will be measured using Resonance Frequency Analysis (RFA) via an Osstell device. The values are recorded as Implant Stability Quotient (ISQ) on a scale from 1 to 100, where higher scores indicate greater stability
Measured: the day of surgery
Secondary Implant Stability using radio frequency analysis (RFA)
Implant stability measured using Resonance Frequency Analysis (RFA) via Osstell. Values recorded as ISQ (1-100) to evaluate osseointegration. where higher scores indicates higher stability
Measured: readings were taken 3 months post operative and 6 months after loading.
Secondary outcomes (1)
Marginal Bone Loss (MBL)
Radiographic evaluation of crestal bone changes measured using cone beam CT. The difference in bone level between baseline and follow-up will be calculated in millimeters.
Measured: cbct was done at implant placement and 3 months post operative and 6 months after loading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start5 Jan 2024
- Primary completion5 Jan 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Bone DensityStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud, Future University in Egypt
- Investigators
- dr lobna abdelaziz aly, PhD, Study director, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378020
- Sponsor's protocol ID
- FUE.REC (25)/7-2023
- Status last verified
- Mar 2026
- First submitted
- 18 Jan 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elsheikh HA, Gadallah AT, Mowafey B, Kandil I, Salem AS. Impact of Three Different Surgical Drilling Protocols on Early Loaded Single Implant in Posterior Maxilla: A 3-year Follow-up. J Contemp Dent Pract. 2022 Aug 1;23(8):819-827. doi: 10.5005/jp-journals-10024-3391.
PubMed 37283017Orak B, Akgul M, Akdogan T, Kahraman OE. Evaluation of implant primary stability using different drilling protocols: an in vitro study. BMC Oral Health. 2025 Aug 9;25(1):1306. doi: 10.1186/s12903-025-06661-4.
PubMed 40783517Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
PubMed 27741329Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.
PubMed 8055503
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Osseodensification Burs Versus Osteotome Preparation on the Stability of Implants Placed in Low Bone Density Areas: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07378020
- Acronym / sponsor ID
- FUE.REC (25)/7-2023
- Conditions
- Low Bone Density
- Keywords
- Osseodensification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 30 Jan 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.
The objective of this study is to compare the primary stability of implant sites prepared using conventional drilling, osseodensification (Densah bur), and osteotome preparation techniques, and to evaluate the influence of these methods on implant success rates in areas of low bone density.
Detailed description
in different conditions implants that lack primary stability is subjected to excessive micromotion that can lead to implant failure. This usually happens when dental implants pass the critical limit of micro-motion. Passing this critical limit can interfere with Osseo-integration and cause fibrous encapsulation of dental implant .
Implant Failure usually occurs in completely edentulous maxillae especially in the posterior area where bone quality is compromised.
Clinicians usually refer implants success rates to the difference in bone quality between mandible and maxilla. Higher failure rates seem to be associated with poor bone quality.
Primary stability is affected by several factors including Bone Quantity and quality, the Implant macro- and micro- design, and the used osteotomy technique.
Osteotomies are usually created using conventional drills, although the implant diameter must be slightly larger than the final drill to ensure primary stability However, this conventional drilling technique might be insufficient to provide the primary stability required for Osseo-integration in areas of low bone quality. Several site preparation techniques have been introduced to enhance primary stability in soft bone. Some clinicians used under-sized drilling however the efficiency of this technique is conditioned by decreasing osteotomy diameter by 10% of implant diameter.
Another method introduced by Dr. Robert Summer. This method uses bone condensers to densify bone through the condensation and expansion of spongy bone as it squeezes bone trabeculae laterally against the wall of implant bed at the site of osteotomy increasing the bone density and conserving osseous tissue around implants.
Recently Osseodensification (OD) was introduced as a novel implant site preparation technique that uses specially designed drills with large negative rake angles. When the drills are operated in a counterclockwise direction it acts as a non-cutting drill which is used to expand and compact bone against the osteotomy walls. This non-subtractive approach aims to increase the primary stability of the dental implants inserted into low-density bone compared with conventional drilling techniques. The drills also can be used as a cutting drill when operated in a clockwise direction according to the operator's need. This type of drill can improve bone density leading to improved implant primary stability, giving these drills the ability to cut and densify without the need for additional tools.
Ossoe-densification technique showed greater insertion torques, bone-to implant contact, and bone area fraction occupancy when compared to standard Drilling technique.
this study is comparing between the three different drilling techniques (conventional, osseo-densification, osteotome bone compaction) in enhancing insertion torque and isq values in posterior maxillary area.
the study also compare between the effect of these techniques on marginal bone loss with follow up 6 month after loading using cbct
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Drilling | Active comparator | Procedure: Conventional OsteotomyImplant sites in this arm will undergo osteotomy preparation using standard conventional drilling sequences according to the implant manufacturer's recommendations prior to implant placement |
| Densah Bur (Osseodensification) | Experimental | Procedure: Densah Bur drillingImplant sites in this arm will undergo osteotomy preparation using the osseodensification technique with Densah burs (Versah) running in a counter-clockwise direction (densifying mode) prior to implant placement. |
| osteotome | Experimental | Procedure: osteotome bone condensationImplant sites in this arm will undergo osteotomy preparation using summers osteotome technique for lateral bone condensation and expansion prior to implant placement |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with low bone density (D3), (D4) Missing maxillary posterior teeth
- edentulous ridge should be 8 mm or more of bone height and bone width ≥ 7mm with adequate inter-occlusal space of at least 8mm,
- Patients with good oral hygiene or willing to improve their oral hygiene.
Key exclusion criteria (4 listed)
- Patients with uncontrolled medical conditions that affect Osseo-integration.
- Patients receiving medications that contraindicate osteotomy.
- Heavy smokers.
- History of receiving irradiation in the head and neck region.
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 |
|---|---|---|
| Conventional OsteotomyAlso: Subtractive Drilling, Standard DrillingThe implant site will be prepared using a standard sequence of drills (subtractive osteotomy) according to the implant manufacturer's instructions. Drilling will be performed with profuse irrigation at speed between 800-1200 rpm to remove bone and prepare the osteotomy site to the final diameter before implant insertion | Procedure or surgery | Conventional Drilling |
| Densah Bur drillingAlso: Osseodensification, Non-subtractive Drillingafter using the pilot drill in a clockwise direction to drill to the desired depth according to the planned implant length The implant site will be prepared using Densah burs (Versah). the motor is adjusted to rotate in a counter-clockwise direction (densifying mode) at 800-1200 rpm with profuse irrigation. This technique expands the osteotomy site by compacting bone at the periphery rather than removing it, aiming to enhance bone density around the implant then the implant is inserted after reaching the desired diameter according to densah bur soft bone drilling protocol | Procedure or surgery | Densah Bur (Osseodensification) |
| osteotome bone condensationAlso: Manual Bone Condensation, Osteotome Expansionosteotomy was prepared using (Xive BoneCondensers by dentsply sirona GERMANY) starting from the pilot drill of 1.7mm in diameter to penetrate the cortical bone and gain access. Then instrumentation was done in the following sequence: 2.0mm, 3.0mm, and 3.4mm according to the planned implant diameter. The osteotome was inserted manually and rotated while being pressed towards the apical part of osteotomy till it reaches the full working depth. Once the desired depth was reached, and before moving to the next instrument we wait 1 min for the osteotome to compress and compact the spongy bone. After the implant bed had been prepared, we inserted the implant immediately to avoid any dimensional changes in the site of osteotomy. | Procedure or surgery | osteotome |
Primary outcome
primary stability using Insertion Torque Value.
Time frame: day of surgery
Evaluation of implant stability was done by measuring Insertion torque. Using the surgical contra-angled hand piece the initial torque value was set to10Ncm then increased sequentially by 5Ncm according to the torque required to place the implant at the desired depth. The final torque value used to drive the implant to its position was recorded as the peak insertion torque
Primary Implant Stability measured through Resonance Frequency Analysis (RFA)
Time frame: the day of surgery
Implant stability will be measured using Resonance Frequency Analysis (RFA) via an Osstell device. The values are recorded as Implant Stability Quotient (ISQ) on a scale from 1 to 100, where higher scores indicate greater stability
Secondary Implant Stability using radio frequency analysis (RFA)
Time frame: readings were taken 3 months post operative and 6 months after loading.
Implant stability measured using Resonance Frequency Analysis (RFA) via Osstell. Values recorded as ISQ (1-100) to evaluate osseointegration. where higher scores indicates higher stability
1 secondary outcome
Marginal Bone Loss (MBL)
Time frame: cbct was done at implant placement and 3 months post operative and 6 months after loading.
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 6 Apr 2026.
- Background: PubMed 37283017Elsheikh HA, Gadallah AT, Mowafey B, Kandil I, Salem AS. Impact of Three Different Surgical Drilling Protocols on Early Loaded Single Implant in Posterior Maxilla: A 3-year Follow-up. J Contemp Dent Pract. 2022 Aug 1;23(8):819-827. doi: 10.5005/jp-journals-10024-3391.
- Background: PubMed 40783517Orak B, Akgul M, Akdogan T, Kahraman OE. Evaluation of implant primary stability using different drilling protocols: an in vitro study. BMC Oral Health. 2025 Aug 9;25(1):1306. doi: 10.1186/s12903-025-06661-4.
- Background: PubMed 27741329Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
- Background: PubMed 8055503Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.
- Individual participant dataSharing planned: No
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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.
dr lobna abdelaziz aly, PhD study director
Future University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Osteotomy, Densah Bur drilling and osteotome bone condensation in people with Low Bone Density, run by Future University in Egypt at 1 site in Egypt.
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 3 inclusion and 4 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 6 Apr 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 Egypt. 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 using Insertion Torque Value. (time frame: day of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07378020, which also lists 4 linked publications.
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 6 Apr 2026.