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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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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
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:

  1. 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.
  2. 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.

  1. 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 groups in NCT07242716
Study groupRoleWhat they receive
knife threads design dental implantExperimentalthe intervention group is the knife threads dental implant using the osseodensification technique
Receives: Device: dental implant
double threads design dental implantActive comparatorthe 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.

  1. 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)
  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.

  1. First posted21 Nov 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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)
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

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.

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