Dental ImplantsNCT06808854
Variable-thread Versus Standard Dental Implants for Replacing Missing Teeth
A study testing Dental implant treatment (variable-thread implants) and Dental implant treatment (standard implants) in people with Dental Implants, run by Mohammed Bin Rashid University of Medicine and Health Sciences at 1 site in United Arab Emirates.
Trial summary
Background and objectives: Primary and secondary implant stability remain the most relevant and reliable clinical indicator for long-term survival of dental implants. Hence modifications of surface characteristics and implant macro-designs were introduced over the last two decades to enhance osseointegration during… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- Dental implant treatment (variable-thread implants) and Dental implant treatment (standard implants)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Aug 2025to 1 Nov 2027
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged more than 18 years.
- Good general health (ASA I or II, according to the American Academy of Anesthesiology).
- Require replacement of a posterior single missing tooth with a dental implant.
- Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline.
- Good compliance and commitment to attend follow-up review appointments.
- Willing to provide informed consent. Exclusion criteria
Show all 15Show fewer
- A healing period of less than four months postextraction at implant site.
- Localized/generalized periodontitis.
- Bone metabolic disease and/or taking medications that affect bone metabolism.
- Long term use of non-steroidal anti-inflammatory medications.
- History of malignancy, radiotherapy or chemotherapy.
- Pregnant or lactating women.
- Severe bruxism or parafunctional habits.
- Large occlusal discrepancies.
- Smokers.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site, 1 recruiting
- Recruiting
MBRU
Dubai
Momen Atieh, BDS, MSc, DClinDent, PhD, +971 4 383 8905, momen.atieh@mbru.ac.ae
About this study
Official title: Variable-thread Versus Standard Dental Implants for Replacing Missing Teeth: a Randomized Controlled Trial
Background and objectives:
Primary and secondary implant stability remain the most relevant and reliable clinical indicator for long-term survival of dental implants. Hence modifications of surface characteristics and implant macro-designs were introduced over the last two decades to enhance osseointegration during the initial phase of healing. In this context, a variable-thread self-cutting implant design was recently introduced to improve primary stability. At present, there are limited number of studies that evaluated this variable-thread implant design. These studies were mostly experimental, of short duration and limited number of participants. Therefore, the aim of the present randomized controlled trial is to compare two implant designs (variable-thread versus standard) in terms of clinical, radiographic and patient-reported outcomes.
Read more
Methods:
A total of 24 participants, who require replacement of a posterior single tooth with dental implant, will be randomly allocated to two equal sized groups. In the test group, the participants will receive variable-thread implants, while standard implants will be placed to replace missing teeth in the control group. In addition to evaluating implant stability, the trial will also report on clinical and radiographic implant outcomes at various time points.
Read the detailed description
Introduction
Implant stability is a prerequisite for successful osseointegration and implant survival as implant micro-motion can compromise osseointegration and lead to implant failure. Maintenance of implant stability over time has been considered one of the implant success criteria that is identified at the primary or secondary level. Primary implant stability occurs as a result of bone compression and mechanical interlocking between implant surface and bone at the time of implant placement. Therefore, primary stability can be largely influenced by implant surface characteristics and implant design in terms of microstructure, thread design and geometry as well as bone quality and quantity. In contrast, secondary implant stability is a biologically mediated process by which bone matures and remodels at the bone-implant interface.
Primary and secondary implant stability remain the most relevant and reliable clinical indicator for long-term survival of dental implants. Hence modifications of surface characteristics and implant macro-designs were introduced over the last two decades to enhance osseointegration during the initial phase of healing. In this context, an implant design was recently introduced to improve primary stability particularly in areas of poor bone quality such as the posterior maxilla. The recently introduced implant has self-cutting self-drilling body with variable thread configurations that are designed to allow controlled compaction and condensation of bone during insertion thus enhancing the initial bone to implant contact. It is claimed that high primary stability is achieved by a controlled bone compaction and densification mechanism resulting from the double variable thread design and the apical sharp threads. In addition, the implant is made up of titanium-zirconium alloy that provide strength, high resistance to loading and biocompatibility. Its moderately rough hydrophilic sandblasted and acid-etched (SLActive) surface can also improve bone-implant contact during the early phase of osseointegration.
At present, there are limited number of studies that evaluated this variable-thread implant design. These studies were mostly experimental, of short duration and limited number of participants. Therefore, the aim of the present randomized controlled trial is to compare two implant designs (variable-thread versus standard) in terms of clinical, radiographic and patient-reported outcomes.
Objectives:
The aims of the present randomized controlled trial are:
- To evaluate implant stability.
- To evaluate the changes in peri-implant marginal bone level.
- To evaluate implant survival rates.
- To evaluate biological and technical complications during the follow-up period.
- Conditions
- Dental Implants
- Being tested
- Dental implant treatment (variable-thread implants), Dental implant treatment (standard implants)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant treatment (variable-thread implants)Procedure or surgery
Replacement of a missing tooth with a dental implant with variable-thread implants
Dental implant treatment (standard implants)Procedure or surgery
Replacement of a missing tooth with a dental implant with standard implants
| Study group | Role | What they receive |
|---|---|---|
| Variable-thread implants | Experimental | The placement of a variable-thread implant to replace single missing posterior tooth Receives: Procedure: Dental implant treatment (variable-thread implants) |
| Standard implants | Active comparator | The placement of standard implant to replace single missing posterior tooth Receives: Procedure: Dental implant treatment (standard implants) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability measurements
A resonance frequency analysis device will used to measure the stability of the dental implant. The measurements will be recorded The use of a resonance frequency analysis device involves the following steps: attach the sensor to the implant, activate the device to measure resonance frequency, read the implant stability quotient (ISQ) value displayed on the device.
Measured: "during implant placement procedure" "1 year" "up to 24 weeks" "through study completion, an average of 1 year".
Secondary outcomes (3)
Changes in peri-implant marginal bone level
Changes in peri-implant marginal bone level will be assessed using standardized peri-apical radiograph
Measured: "during implant placement procedure" "1 year" "up to 24 weeks" "through study completion, an average of 1 year".
Implant survival rate
Implant survival rate will be assessed clinically after one year of implant restoration and annually up to three years. Unlike other measurements, implant survival, defined as a dental implant that remains in place and functional, will be only assessed once a year.
Measured: "1 year" "up to 24 weeks" "through study completion, an average of 1 year".
Biological and technical complications
Biological and technical complications will be recorded during the follow-up period
Measured: "1 year" "up to 24 weeks" "through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Model description
- Prospective, in which participants will be recruited and then followed up throughout a specified period of time. Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either test or control groups.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Momen Atieh, Mohammed Bin Rashid University of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808854
- Sponsor's protocol ID
- MBRUMHS - 2024
- Status last verified
- Feb 2025
- First submitted
- 7 Jan 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variable-thread Versus Standard Dental Implants for Replacing Missing Teeth: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06808854
- Acronym / sponsor ID
- MBRUMHS - 2024
- Conditions
- Dental Implants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health SciencesUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 5 Feb 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.
Background and objectives:
Primary and secondary implant stability remain the most relevant and reliable clinical indicator for long-term survival of dental implants. Hence modifications of surface characteristics and implant macro-designs were introduced over the last two decades to enhance osseointegration during the initial phase of healing. In this context, a variable-thread self-cutting implant design was recently introduced to improve primary stability. At present, there are limited number of studies that evaluated this variable-thread implant design. These studies were mostly experimental, of short duration and limited number of participants. Therefore, the aim of the present randomized controlled trial is to compare two implant designs (variable-thread versus standard) in terms of clinical, radiographic and patient-reported outcomes.
Methods:
A total of 24 participants, who require replacement of a posterior single tooth with dental implant, will be randomly allocated to two equal sized groups. In the test group, the participants will receive variable-thread implants, while standard implants will be placed to replace missing teeth in the control group. In addition to evaluating implant stability, the trial will also report on clinical and radiographic implant outcomes at various time points.
Detailed description
Introduction
Implant stability is a prerequisite for successful osseointegration and implant survival as implant micro-motion can compromise osseointegration and lead to implant failure. Maintenance of implant stability over time has been considered one of the implant success criteria that is identified at the primary or secondary level. Primary implant stability occurs as a result of bone compression and mechanical interlocking between implant surface and bone at the time of implant placement. Therefore, primary stability can be largely influenced by implant surface characteristics and implant design in terms of microstructure, thread design and geometry as well as bone quality and quantity. In contrast, secondary implant stability is a biologically mediated process by which bone matures and remodels at the bone-implant interface.
Primary and secondary implant stability remain the most relevant and reliable clinical indicator for long-term survival of dental implants. Hence modifications of surface characteristics and implant macro-designs were introduced over the last two decades to enhance osseointegration during the initial phase of healing. In this context, an implant design was recently introduced to improve primary stability particularly in areas of poor bone quality such as the posterior maxilla. The recently introduced implant has self-cutting self-drilling body with variable thread configurations that are designed to allow controlled compaction and condensation of bone during insertion thus enhancing the initial bone to implant contact. It is claimed that high primary stability is achieved by a controlled bone compaction and densification mechanism resulting from the double variable thread design and the apical sharp threads. In addition, the implant is made up of titanium-zirconium alloy that provide strength, high resistance to loading and biocompatibility. Its moderately rough hydrophilic sandblasted and acid-etched (SLActive) surface can also improve bone-implant contact during the early phase of osseointegration.
At present, there are limited number of studies that evaluated this variable-thread implant design. These studies were mostly experimental, of short duration and limited number of participants. Therefore, the aim of the present randomized controlled trial is to compare two implant designs (variable-thread versus standard) in terms of clinical, radiographic and patient-reported outcomes.
Objectives:
The aims of the present randomized controlled trial are:
- To evaluate implant stability.
- To evaluate the changes in peri-implant marginal bone level.
- To evaluate implant survival rates.
- To evaluate biological and technical complications during the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, in which participants will be recruited and then followed up throughout a specified period of time. Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either test or control groups.
| Arm | Type | Receives |
|---|---|---|
| Variable-thread implants | Experimental | Procedure: Dental implant treatment (variable-thread implants)The placement of a variable-thread implant to replace single missing posterior tooth |
| Standard implants | Active comparator | Procedure: Dental implant treatment (standard implants)The placement of standard implant to replace single missing posterior tooth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Aged more than 18 years.
- Good general health (ASA I or II, according to the American Academy of Anesthesiology).
- Require replacement of a posterior single missing tooth with a dental implant.
- Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline.
- Good compliance and commitment to attend follow-up review appointments.
Key exclusion criteria (0 listed)
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 implant treatment (variable-thread implants)Replacement of a missing tooth with a dental implant with variable-thread implants | Procedure or surgery | Variable-thread implants |
| Dental implant treatment (standard implants)Replacement of a missing tooth with a dental implant with standard implants | Procedure or surgery | Standard implants |
Primary outcome
Implant stability measurements
Time frame: "during implant placement procedure" "1 year" "up to 24 weeks" "through study completion, an average of 1 year".
A resonance frequency analysis device will used to measure the stability of the dental implant. The measurements will be recorded The use of a resonance frequency analysis device involves the following steps: attach the sensor to the implant, activate the device to measure resonance frequency, read the implant stability quotient (ISQ) value displayed on the device.
3 secondary outcomes
Changes in peri-implant marginal bone level
Time frame: "during implant placement procedure" "1 year" "up to 24 weeks" "through study completion, an average of 1 year".
Implant survival rate
Time frame: "1 year" "up to 24 weeks" "through study completion, an average of 1 year".
Biological and technical complications
Time frame: "1 year" "up to 24 weeks" "through study completion, an average of 1 year".
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 1 Jul 2025.
Related trials for Dental Implants
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
Recruiting
Multi-Evaluation of Dental Abutments With Different Surfaces
Edentulism, Dental Implant
Recruiting
Evaluation of Different Grafting Technique of Thin Gingival Phenotype With Delayed Dental Implants
Implant Dentistry, Connective Tissue Graft
Not yet recruiting
Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Recruiting
Clinical Performance of Dual-cantilevered Single-implant Bridge
Dental Implant Failed
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant treatment (variable-thread implants) and Dental implant treatment (standard implants) in people with Dental Implants, run by Mohammed Bin Rashid University of Medicine and Health Sciences at 1 site in United Arab Emirates.
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 15 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 1 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 United Arab Emirates. 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?
Contact Momen Atieh, BDS, MSc, DClinDent, PhD (+9714 383 8905, momen.atieh@mbru.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability measurements (time frame: "during implant placement procedure" "1 year" "up to 24 weeks" "through study completion, an average of 1 year".). 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 1 Jul 2025.