Evaluation of Implant Site Preparation With Three Different Drilling Systems in Posterior MaxillaNCT07068750
Evaluation of Implant Site Preparation With Three Different Drilling Systems in Posterior Maxilla (Randomized Controlled Clinical Trial)
A study testing patients received dental implants using single drilling system in posterior maxilla, patients received dental implants using Densah burs in posterior maxilla and patients received dental implants using conventional drills in posterior maxilla in people with Evaluation of Implant Site Preparation With Three Different Drilling Systems in Posterior Maxilla, run by ALZAHRANI,MOHAMMED AHMED Y at 1 site in Egypt.
Trial summary
The rationale for conducting this study is to compare between three implant drilling systems (conventional sequential system, single drilling system and osseodensification surgical drills) for implant site preparation in the posterior maxillay region through measuring implant stability and bone density around dental… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluation of Implant Site Preparation With Three Different Drilling Systems in Posterior Maxilla
- What is being tested?
- patients received dental implants using single drilling system in posterior maxilla, patients received dental implants using Densah burs in posterior maxilla and patients received dental implants using conventional drills in posterior maxilla
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Aug 2023to 3 Jun 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient between 20-50 years old.
- remaining bone height of more than 8 mm, remaining bone width of 6 mm
- Adequate keratinized soft tissue.
- Favorable pattern of occlusion.
- Good oral hygiene.
- Patient ability to comply with the required recall visits
Who cannot join
- Insufficient bone width (less than 6 mm) mesiodistal or buccolingually.
- Patients having any uncontrolled systemic disease which could affect bone healing.
- Patients treated with radiotherapy to the head and neck area within the past 12 months.
- Heavy Smokers (more than 20 cigarette per day) according to WHO.
- Inability or unwillingness to return for follow-up visits.
Trial locations and contacts
1 site in 1 country.
About this study
The rationale for conducting this study is to compare between three implant drilling systems (conventional sequential system, single drilling system and osseodensification surgical drills) for implant site preparation in the posterior maxillay region through measuring implant stability and bone density around dental implants. Therefore, the primary objective of this study is to evaluate the primary and secondary implant stability performed by the three types through measuring implant stability quotient (ISQ), whereas the secondary objective is to assess marginal bone loss, the operation time for the osteotomy preparation, and finally bone density through measuring grey values on CBCT around implants for all drilling methods at different evaluation intervals of the study.
Read the detailed description
Primary stability is a critical factor that determines the long-term success of dental implants. It is responsible for preventing the micro- motion of the implant in the bone site, promoting natural healing and effective bone formation until adequate biological stability has been established. Primary stability of dental implants is highly dependent on implant design, surgical technique and the bone density and quality. Conventional implant shaping drills are widely used because they are easy to handle, time-efficient, and not expensive. Nevertheless, the heat that they generate might cause tissue damage, necrosis to the surrounding structures, difficulty in providing a proper three-dimensional positioning and the risk of invading and injuring important anatomical structures such as the inferior alveolar nerve and the Schneiderian membrane. Hence, several studies introduce different techniques and methods to resolve these problems. Recently, new hollow drill in a single drilling system was developed. It was hypothesized that hollow drill design with single drilling system results in decreasing the time for surgery (faster implant placement) and minimum bone removal for implant site preparation. Moreover, it was found that it reduces bone trauma, micro-fractures and allow fasters healing time. Moreover, the hollow design of the single drilling system allows harvesting of the bone core, that bone which result during the osteotomy site preparation can be used in bone grafting as autogenous bone grafting material. Osseodensification (OD) is also a new method of biomechanical bone preparation performed for dental implant placement. The procedure is characterized by low plastic deformation of bone that is created by rolling and sliding contact using a densifying bur that is fluted such that it densifies the bone with minimal heat elevation. OD, a bone nonextraction technique, was developed by Huwais 2013 and done using specially designed burs (Densah™ burs) that help densify bone as they prepare an osteotomy these burs provide advantages of both osteotomes combining the speed along with improved tactile control of the drills during osteotomy.
- Conditions
- Evaluation of Implant Site Preparation With Three Different Drilling Systems in Posterior Maxilla
- Being tested
- patients received dental implants using single drilling system in posterior maxilla, patients received dental implants using Densah burs in posterior maxilla, patients received dental implants using conventional drills in posterior maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients received dental implants using single drilling system in posterior maxillaProcedure or surgery
All patients will be operated under local anaesthesia Articaine hydrochloride 4% with Epinephrine (1:100,000). Crestal incision will performed and full thickness mucoperiosteal flap will be reflected to access the site. The implant will be prepared using the new specially designed drill. These drills are available with four drilling lengths (7, 9, 11, 13 mm) characterized by different color codes, and three different diameters (4, 4.5, 5 mm). They allow a single drilling procedure before implant placement in bone with all types. Drilling speed of 1500 RPM and profuse normal saline irrigation will be used throughout the drilling procedure. Tapered implants will be inserted in all patients with insertion torque 30-50Ncm. Suturing of the flap with interrupted sutures, using 5/0 polypropylene suturing material (According to the protocol provided by the manufacturer).
patients received dental implants using Densah burs in posterior maxillaProcedure or surgery
All patients will be operated under local anaesthesia Articaine hydrochloride 4% with Epinephrine (1:100,000). Crestal incision will be performed and full thickness mucoperiosteal flap will be reflected to access the site. Implant sites will be prepared using osseodensification burs (Densah, Versah) at 1200 rpm in the following sequence: (I) pilot (clockwise); (II) WT1828 (counterclockwise), and (III) WT2838 (counterclockwise). These burs have a cutting chisel edge, a tapered shank and non- cutting edges with four or more lands with a negative rake angle. Suturing of the flap with interrupted sutures, using 5/0 polypropylene suturing material (According to the protocol provided by the manufacturer).
patients received dental implants using conventional drills in posterior maxillaProcedure or surgery
All patients will be operated under local anaesthesia Articaine hydrochloride 4% with Epinephrine (1:100,000). Crestal incision will be performed and full thickness mucoperiosteal flap will be reflected to access the site. Implant sites will be prepared using conventional surgical drills at 1200 rpm. Suturing of the flap with interrupted sutures, using 5/0 polypropylene suturing material (According to the protocol provided by the manufacturer).
| Study group | Role | What they receive |
|---|---|---|
| Group I: 10 patients received dental implants using single drilling system in posterior maxilla | Active comparator | Not described Receives: Procedure: patients received dental implants using single drilling system in posterior maxilla |
| Group II: 10 patients received dental implants using Densah burs in posterior maxilla | Active comparator | Not described Receives: Procedure: patients received dental implants using Densah burs in posterior maxilla |
| Group III: 10 patients received dental implants using conventional drills in posterior maxilla | Active comparator | Not described Receives: Procedure: patients received dental implants using conventional drills in posterior maxilla |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary and secondary implant stability
the primary objective of this study is to evaluate the primary and secondary implant stability performed by the three types through measuring implant stability quotient (ISQ)
Measured: the primary stability will be taken immediately after implant placement. while secondary implant stability will be taken after 6-months
Secondary outcomes (2)
assessment of marginal bone loss
The secondary objective is to assess marginal bone loss measured on CBCT around implants for all drilling methods at different evaluation intervals of the study.
Measured: marginal bone loss will be measured after 6 months from implant placement
operation time
The secondary objective is to assess the operation time for the osteotomy preparation in each study group.
Measured: operation time will be measured immediately during implant placement in minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start16 Aug 2023
- Primary completion1 May 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of Implant Site Preparation With Three Different Drilling Systems in Posterior MaxillaStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALZAHRANI,MOHAMMED AHMED Y
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ALZAHRANI,MOHAMMED AHMED Y, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068750
- Sponsor's protocol ID
- A01011023OM
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Implant Site Preparation With Three Different Drilling Systems in Posterior Maxilla (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07068750
- Acronym / sponsor ID
- A01011023OM
- Conditions
- Evaluation of Implant Site Preparation With Three Different Drilling Systems in Posterior Maxilla
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ALZAHRANI,MOHAMMED AHMED YUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 16 Jul 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 rationale for conducting this study is to compare between three implant drilling systems (conventional sequential system, single drilling system and osseodensification surgical drills) for implant site preparation in the posterior maxillay region through measuring implant stability and bone density around dental implants. Therefore, the primary objective of this study is to evaluate the primary and secondary implant stability performed by the three types through measuring implant stability quotient (ISQ), whereas the secondary objective is to assess marginal bone loss, the operation time for the osteotomy preparation, and finally bone density through measuring grey values on CBCT around implants for all drilling methods at different evaluation intervals of the study.
Detailed description
Primary stability is a critical factor that determines the long-term success of dental implants. It is responsible for preventing the micro- motion of the implant in the bone site, promoting natural healing and effective bone formation until adequate biological stability has been established. Primary stability of dental implants is highly dependent on implant design, surgical technique and the bone density and quality. Conventional implant shaping drills are widely used because they are easy to handle, time-efficient, and not expensive. Nevertheless, the heat that they generate might cause tissue damage, necrosis to the surrounding structures, difficulty in providing a proper three-dimensional positioning and the risk of invading and injuring important anatomical structures such as the inferior alveolar nerve and the Schneiderian membrane. Hence, several studies introduce different techniques and methods to resolve these problems. Recently, new hollow drill in a single drilling system was developed. It was hypothesized that hollow drill design with single drilling system results in decreasing the time for surgery (faster implant placement) and minimum bone removal for implant site preparation. Moreover, it was found that it reduces bone trauma, micro-fractures and allow fasters healing time. Moreover, the hollow design of the single drilling system allows harvesting of the bone core, that bone which result during the osteotomy site preparation can be used in bone grafting as autogenous bone grafting material. Osseodensification (OD) is also a new method of biomechanical bone preparation performed for dental implant placement. The procedure is characterized by low plastic deformation of bone that is created by rolling and sliding contact using a densifying bur that is fluted such that it densifies the bone with minimal heat elevation. OD, a bone nonextraction technique, was developed by Huwais 2013 and done using specially designed burs (Densah™ burs) that help densify bone as they prepare an osteotomy these burs provide advantages of both osteotomes combining the speed along with improved tactile control of the drills during osteotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I: 10 patients received dental implants using single drilling system in posterior maxilla | Active comparator | Procedure: patients received dental implants using single drilling system in posterior maxilla |
| Group II: 10 patients received dental implants using Densah burs in posterior maxilla | Active comparator | Procedure: patients received dental implants using Densah burs in posterior maxilla |
| Group III: 10 patients received dental implants using conventional drills in posterior maxilla | Active comparator | Procedure: patients received dental implants using conventional drills in posterior maxilla |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient between 20-50 years old.
- remaining bone height of more than 8 mm, remaining bone width of 6 mm
- Adequate keratinized soft tissue.
- Favorable pattern of occlusion.
- Good oral hygiene.
Key exclusion criteria (5 listed)
- Insufficient bone width (less than 6 mm) mesiodistal or buccolingually.
- Patients having any uncontrolled systemic disease which could affect bone healing.
- Patients treated with radiotherapy to the head and neck area within the past 12 months.
- Heavy Smokers (more than 20 cigarette per day) according to WHO.
- Inability or unwillingness to return for follow-up visits.
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 |
|---|---|---|
| patients received dental implants using single drilling system in posterior maxillaAll patients will be operated under local anaesthesia Articaine hydrochloride 4% with Epinephrine (1:100,000). Crestal incision will performed and full thickness mucoperiosteal flap will be reflected to access the site. The implant will be prepared using the new specially designed drill. These drills are available with four drilling lengths (7, 9, 11, 13 mm) characterized by different color codes, and three different diameters (4, 4.5, 5 mm). They allow a single drilling procedure before implant placement in bone with all types. Drilling speed of 1500 RPM and profuse normal saline irrigation will be used throughout the drilling procedure. Tapered implants will be inserted in all patients with insertion torque 30-50Ncm. Suturing of the flap with interrupted sutures, using 5/0 polypropylene suturing material (According to the protocol provided by the manufacturer). | Procedure or surgery | Group I: 10 patients received dental implants using single drilling system in posterior maxilla |
| patients received dental implants using Densah burs in posterior maxillaAll patients will be operated under local anaesthesia Articaine hydrochloride 4% with Epinephrine (1:100,000). Crestal incision will be performed and full thickness mucoperiosteal flap will be reflected to access the site. Implant sites will be prepared using osseodensification burs (Densah, Versah) at 1200 rpm in the following sequence: (I) pilot (clockwise); (II) WT1828 (counterclockwise), and (III) WT2838 (counterclockwise). These burs have a cutting chisel edge, a tapered shank and non- cutting edges with four or more lands with a negative rake angle. Suturing of the flap with interrupted sutures, using 5/0 polypropylene suturing material (According to the protocol provided by the manufacturer). | Procedure or surgery | Group II: 10 patients received dental implants using Densah burs in posterior maxilla |
| patients received dental implants using conventional drills in posterior maxillaAll patients will be operated under local anaesthesia Articaine hydrochloride 4% with Epinephrine (1:100,000). Crestal incision will be performed and full thickness mucoperiosteal flap will be reflected to access the site. Implant sites will be prepared using conventional surgical drills at 1200 rpm. Suturing of the flap with interrupted sutures, using 5/0 polypropylene suturing material (According to the protocol provided by the manufacturer). | Procedure or surgery | Group III: 10 patients received dental implants using conventional drills in posterior maxilla |
Primary outcome
primary and secondary implant stability
Time frame: the primary stability will be taken immediately after implant placement. while secondary implant stability will be taken after 6-months
the primary objective of this study is to evaluate the primary and secondary implant stability performed by the three types through measuring implant stability quotient (ISQ)
2 secondary outcomes
assessment of marginal bone loss
Time frame: marginal bone loss will be measured after 6 months from implant placement
operation time
Time frame: operation time will be measured immediately during implant placement in minutes.
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 16 Jul 2025.
- Individual participant dataSharing planned: Undecided
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 patients received dental implants using single drilling system in posterior maxilla, patients received dental implants using Densah burs in posterior maxilla and patients received dental implants using conventional drills in posterior maxilla in people with Evaluation of Implant Site Preparation With Three Different Drilling Systems in Posterior Maxilla, run by ALZAHRANI,MOHAMMED AHMED Y 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 6 inclusion and 5 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 16 Jul 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 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 and secondary implant stability (time frame: the primary stability will be taken immediately after implant placement. while secondary implant stability will be taken after 6-months). 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 16 Jul 2025.