Primary Stability of Knife Threads Dental Implant Versus Double Threads Using Osseodensification TechniqueNCT07242716
Evaluation of the Effect of Different Thread Designs on Primary Stability of Dental Implant Using Osseodensification Technique in Posterior Maxilla : Randomized Clinical Trial
A study testing dental implant in people with Primary Stability of Knife Threads Dental Implant Versus Double Threads Using Osseodensification Technique, run by Cairo University.
Trial summary
the aim of this study is to compare the primary stability of dental implant with knife threads design versus dental implant with double threads design using osseodensification technique in posterior maxilla . Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Primary Stability of Knife Threads Dental Implant Versus Double Threads Using Osseodensification Technique
- What is being tested?
- dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Dec 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age from 20 to 60 years
- both sex
- patient with deficient width in posterior maxilla
Who cannot join
- inadequate oral hygiene
- smoking habit > 10 cigarettes per day
- abuse of alcohol or drugs
- pregnancy
- local or systemic infection
- sever hepatic or renal dysfunction
Show all 10Show fewer
- bony or soft tissue pathological condition at surgical site
- uncontrolled systemic diseases
- parafunctional habits
- inability or unwillingness to return for follow-up visits
About this study
the aim of this study is to compare the primary stability of dental implant with knife threads design versus dental implant with double threads design using osseodensification technique in posterior maxilla .
Read the detailed description
Introduction:
- Background and rationale: Research question: Is the use of knife threads dental implants enhancing primary stability in the posterior maxilla more than double threads when using the osseodensification technique? Statement of the problem: Implant design affects implant stability especially thread design. Osseodensification (OD) working in a non-subtractive fashion, condense the implant osteotomy soft bone in lateral direction, leading to a greater bone volume and density, an increase in the bone implant contact, with subsequent increase in insertion torque levels, and reduction in micromotion (Seo et al., 2022). However, it has been claimed that OD increases the implant bone bed density but does not improve implant primary stability (Almutairi et al., 2018). Thus, the aim of this study is to evaluate the effect of different threads design on primary stability of dental implant using osseodensification on posterior edentulous maxillary region.
- Rationale for conducting the research:
Dental implants have become a treatment option widely used for the replacement of lost teeth. The development of dental implants has had a major impact on the patients. The implant supported oral restoration has become an increasingly used treatment option for partially and completely edentulous patients (Duong et al., 2022).
The replacement of a tooth using an implant is derived from an evolution in concepts, technology, and clinical applications, following years of basic research and fundamental studies on the concept of osseointegration (Cooper and Shirazi, 2021).
Implant design parameters lay the foundation for properties like implant primary stability and ability to sustain loading during or after osseointegration (Huang et al., 2023). Implant design is divided into two major categories: micro design and macro design. Macro design includes implant body shape, thread and thread design, while micro design constitutes surface morphology, implant materials, and surface coating (Kumar et al., 2024).
Surgical techniques of implant placement also play a vital role in establishing osseointegration. If, during ostetomy preparation, drilling temperature exceeds 47°C for more than a minute, local osteonecrosis and impair osseointegration may happen (Soldatos et al., 2022).Various drilling protocols have been established for implant placement namely, conventional, under preparation or OD techniques (Inchingolo et al., 2021).
Therefore, a high initial (primary) implant stability is essential for successful osseointegration of implants with the adjacent bone, and this itself is influenced by several factors including implant design, size, macro-and micro-surface, quality and quantity of bone, and the surgical technique used for implant placement in addition to the operator's skills (Xiao et al., 2024).
Bone density is a key factor to consider when predicting implant stability. A good surgical technique and good stability favors implant osseointegration. The long-term success of implant therapy is achieved by the primary stability of the implant for mechanical support from the surrounding bone in the early stage and osseointegration between the surrounding bone and implant through bone regeneration and remodeling in the late stage (Huang et al., 2023). Primary stability is especially necessary in poor quality bone. The instability of dental implants results in fibrous encapsulation and failure to achieve osseointegration (Hossain et al., 2023).
Clinically, the dental implant primary stability can be evaluated using several techniques, such as the amount of torque needed during insertion, or after insertion using the resonance frequency analysis technology implemented in the Osstell device, or the mechanical percussion principle used in the Periotest (Almutairi et al., 2018).
Although the OD may minimize the use of other more invasive techniques, such as ridge splitting, sinus lifting, and onlay bone grafting, there has been a claim that the OD surgical technique may not be effective in improving the primary stability of dental implants, and that the dental implant macro-design is not crucial for the implant primary stability so long as the surrounding bone is of good quantity and quality (Othman et al., 2024).
Explanation for choice of comparators:
The use of osseodensification in combination with these thread designs is an important factor in this study, as it enhances bone density and improves implant stability through controlled bone compaction. Therefore, comparing different thread designs such as those with aggressive threads for great mechanical retention versus those with more moderate threads for less bone stress allows us to observe differences in primary stability outcomes.
- Objectives: The aim of this study is to compare the primary stability of dental implant with knife threads design versus dental implant with double threads design using osseodensification technique.
Hypothesis:
We hypothesis that using knife threads dental implant will provide primary stability of dental implants in the posterior maxillary region more than double threads dental implant.
- Being tested
- dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implantDevice
dental implant with double thread design
dental implantDevice
dental implant with knife threads design
| Study group | Role | What they receive |
|---|---|---|
| knife threads design dental implant | Experimental | the intervention group is the knife threads dental implant using the osseodensification technique Receives: Device: dental implant |
| double threads design dental implant | Active comparator | the control group is the double threads dental implant using osseodensification technique Receives: Device: dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary stability of dental implant
measuring the primary stability using osstell device and smart peg
Measured: primary stability will be measured immediately after implant placement and 2nd record after 4 months
Secondary outcomes (1)
marginal bone height changes
measuring changes in marginal bone height using cone beam CT
Measured: after 6 months of dental implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Stability of Knife Threads Dental Implant Versus Double Threads Using Osseodensification TechniqueStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akram Osman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242716
- Sponsor's protocol ID
- stability of dental implant
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Different Thread Designs on Primary Stability of Dental Implant Using Osseodensification Technique in Posterior Maxilla : Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07242716
- Acronym / sponsor ID
- stability of dental implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 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 aim of this study is to compare the primary stability of dental implant with knife threads design versus dental implant with double threads design using osseodensification technique in posterior maxilla .
Detailed description
Introduction:
- Background and rationale: Research question: Is the use of knife threads dental implants enhancing primary stability in the posterior maxilla more than double threads when using the osseodensification technique? Statement of the problem: Implant design affects implant stability especially thread design. Osseodensification (OD) working in a non-subtractive fashion, condense the implant osteotomy soft bone in lateral direction, leading to a greater bone volume and density, an increase in the bone implant contact, with subsequent increase in insertion torque levels, and reduction in micromotion (Seo et al., 2022). However, it has been claimed that OD increases the implant bone bed density but does not improve implant primary stability (Almutairi et al., 2018). Thus, the aim of this study is to evaluate the effect of different threads design on primary stability of dental implant using osseodensification on posterior edentulous maxillary region.
- Rationale for conducting the research:
Dental implants have become a treatment option widely used for the replacement of lost teeth. The development of dental implants has had a major impact on the patients. The implant supported oral restoration has become an increasingly used treatment option for partially and completely edentulous patients (Duong et al., 2022).
The replacement of a tooth using an implant is derived from an evolution in concepts, technology, and clinical applications, following years of basic research and fundamental studies on the concept of osseointegration (Cooper and Shirazi, 2021).
Implant design parameters lay the foundation for properties like implant primary stability and ability to sustain loading during or after osseointegration (Huang et al., 2023). Implant design is divided into two major categories: micro design and macro design. Macro design includes implant body shape, thread and thread design, while micro design constitutes surface morphology, implant materials, and surface coating (Kumar et al., 2024).
Surgical techniques of implant placement also play a vital role in establishing osseointegration. If, during ostetomy preparation, drilling temperature exceeds 47°C for more than a minute, local osteonecrosis and impair osseointegration may happen (Soldatos et al., 2022).Various drilling protocols have been established for implant placement namely, conventional, under preparation or OD techniques (Inchingolo et al., 2021).
Therefore, a high initial (primary) implant stability is essential for successful osseointegration of implants with the adjacent bone, and this itself is influenced by several factors including implant design, size, macro-and micro-surface, quality and quantity of bone, and the surgical technique used for implant placement in addition to the operator's skills (Xiao et al., 2024).
Bone density is a key factor to consider when predicting implant stability. A good surgical technique and good stability favors implant osseointegration. The long-term success of implant therapy is achieved by the primary stability of the implant for mechanical support from the surrounding bone in the early stage and osseointegration between the surrounding bone and implant through bone regeneration and remodeling in the late stage (Huang et al., 2023). Primary stability is especially necessary in poor quality bone. The instability of dental implants results in fibrous encapsulation and failure to achieve osseointegration (Hossain et al., 2023).
Clinically, the dental implant primary stability can be evaluated using several techniques, such as the amount of torque needed during insertion, or after insertion using the resonance frequency analysis technology implemented in the Osstell device, or the mechanical percussion principle used in the Periotest (Almutairi et al., 2018).
Although the OD may minimize the use of other more invasive techniques, such as ridge splitting, sinus lifting, and onlay bone grafting, there has been a claim that the OD surgical technique may not be effective in improving the primary stability of dental implants, and that the dental implant macro-design is not crucial for the implant primary stability so long as the surrounding bone is of good quantity and quality (Othman et al., 2024).
Explanation for choice of comparators:
The use of osseodensification in combination with these thread designs is an important factor in this study, as it enhances bone density and improves implant stability through controlled bone compaction. Therefore, comparing different thread designs such as those with aggressive threads for great mechanical retention versus those with more moderate threads for less bone stress allows us to observe differences in primary stability outcomes.
- Objectives: The aim of this study is to compare the primary stability of dental implant with knife threads design versus dental implant with double threads design using osseodensification technique.
Hypothesis:
We hypothesis that using knife threads dental implant will provide primary stability of dental implants in the posterior maxillary region more than double threads dental implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| knife threads design dental implant | Experimental | Device: dental implantthe intervention group is the knife threads dental implant using the osseodensification technique |
| double threads design dental implant | Active comparator | Device: dental implantthe control group is the double threads dental implant using osseodensification technique |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age from 20 to 60 years
- both sex
- patient with deficient width in posterior maxilla
Key exclusion criteria (10 listed)
- inadequate oral hygiene
- smoking habit > 10 cigarettes per day
- abuse of alcohol or drugs
- pregnancy
- local or systemic infection
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 implantdental implant with double thread design | Device | double threads design dental implant |
| dental implantdental implant with knife threads design | Device | knife threads design dental implant |
Primary outcome
primary stability of dental implant
Time frame: primary stability will be measured immediately after implant placement and 2nd record after 4 months
measuring the primary stability using osstell device and smart peg
1 secondary outcome
marginal bone height changes
Time frame: after 6 months of dental implant placement
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 21 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing dental implant in people with Primary Stability of Knife Threads Dental Implant Versus Double Threads Using Osseodensification Technique, run by Cairo University.
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 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: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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 of dental implant (time frame: primary stability will be measured immediately after implant placement and 2nd record after 4 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 21 Nov 2025.