Partially Edentulous PatientsNCT07557836
Comparative Clinical Study of Implant Stability and Peri-implant Bone Loss in Two Implant Designs
A study testing Double-threaded straight-body dental implant and Triple-threaded conical-body dental implant in people with Partially Edentulous Patients and Implant Stability, run by Career Postgraduate Institute of Dental Science and Hospital Lucknow at 1 site in India.
Trial summary
This clinical study was conducted to evaluate the effect of different dental implant designs on implant stability and peri-implant bone levels during the early healing phase. Dental implants are widely used for the replacement of missing teeth, and their long-term success depends on achieving adequate primary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partially Edentulous Patients, Implant Stability, Peri-implant Marginal Bone Loss
- What is being tested?
- Double-threaded straight-body dental implant and Triple-threaded conical-body dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 20 Jun 2022to 12 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and above
- Patients with missing mandibular premolars or molars requiring implant-supported restoration
- Presence of adequate bone volume and density at the implant site for proper implant placement
- Patients with good general health and no systemic conditions affecting healing
- Patients maintaining satisfactory oral hygiene
- Patients who are cooperative and able to understand the treatment procedure
- Patients willing to undergo implant surgery and attend follow-up visits
- Patients who provide written informed consent
Who cannot join
- Patients with active infection or pathology at the implant site
- Patients with insufficient bone quality or volume for implant placement
- Patients with systemic diseases or conditions that may impair healing
- Patients with a history of bleeding disorders or on anticoagulant therapy
- Immunocompromised or medically compromised patients
- Patients with poor oral hygiene or non-compliance
- Pregnant or lactating women
- Patients unwilling to participate or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
India1 site
Career Postgraduate Institute of Dental Science and Hospital, Lucknow, Indi
Lucknow, Uttar Pradesh, 226020
About this study
Official title: A Comparative Study to Evaluate Implant Stability and Peri-Implant Marginal Bone Loss Around Two Different Thread and Body Designs of Implants at Specified Time Intervals - An In Vivo Study
This clinical study was conducted to evaluate the effect of different dental implant designs on implant stability and peri-implant bone levels during the early healing phase. Dental implants are widely used for the replacement of missing teeth, and their long-term success depends on achieving adequate primary stability and maintaining the surrounding bone. Variations in implant design, including thread configuration and body geometry, may influence the mechanical and biological behavior of implants, thereby affecting treatment outcomes.
The purpose of this study was to compare two different implant designs: double-threaded straight-body implants and triple-threaded conical-body implants. A total of 30 patients requiring implant-supported restorations in the posterior mandibular region were included in the study. Participants were randomly allocated into two groups, with each group receiving one type of implant design.
Read more
Implant stability was assessed using resonance frequency analysis (RFA), which provides implant stability quotient (ISQ) values as an objective measure of stability. In addition, peri-implant marginal bone levels were evaluated using standardized intraoral radiographs. These measurements were recorded at three time points: at the time of implant placement (baseline), at 3 months, and at 6 months after placement.
The primary objective of the study was to determine whether implant design influences implant stability over time. The secondary objective was to evaluate and compare marginal bone loss around the implants between the two groups during the early healing period.
The main research question addressed in this study was: Does the difference in implant thread design and body geometry significantly affect implant stability and peri-implant marginal bone loss during the early healing phase?
It was hypothesized that implants with a conical body design and multiple thread configuration may provide higher stability due to improved bone engagement and load distribution, while maintaining comparable bone levels around the implant.
The findings of this study are expected to provide clinically relevant evidence regarding the influence of implant macro-design on treatment outcomes. This may assist dental practitioners in selecting appropriate implant systems to enhance primary stability, promote successful osseointegration, and improve long-term prognosis in implant therapy.
Read the detailed description
Dental implants have become a widely accepted and predictable treatment modality for the rehabilitation of partially and completely edentulous patients. The long-term success of dental implants is primarily dependent on achieving and maintaining adequate implant stability and preserving peri-implant bone levels. Implant stability is influenced by several factors, including bone quality, surgical technique, and implant design. Among these, implant macro-design-particularly thread configuration and body geometry-plays a critical role in determining primary stability and stress distribution at the bone-implant interface.
Implant designs vary in terms of thread pitch, depth, and number of threads, as well as body shape (straight/cylindrical versus tapered/conical). Conical implants are believed to enhance primary stability by generating compressive forces within the surrounding bone, especially in areas of low bone density. Similarly, multiple-thread configurations may increase bone-to-implant contact and improve insertion efficiency and mechanical engagement. However, the combined influence of thread design and implant body geometry on implant stability and peri-implant bone behavior remains an area requiring further clinical investigation.
The present study was designed as a randomized, prospective interventional clinical trial with a parallel-group design to evaluate and compare implant stability and peri-implant marginal bone loss between two implant systems with different macro-design characteristics. A total of 30 patients requiring implant-supported restoration in the posterior mandibular region were included. Participants were randomly assigned into two groups using a computer-generated randomization method to ensure unbiased allocation.
Group A received double-threaded straight-body implants, while group B received triple-threaded conical-body implants. All implant placements were performed under standardized clinical conditions using a two-stage surgical protocol. Preoperative clinical and radiographic assessments were carried out to determine bone quality, quantity, and suitability for implant placement. Implant dimensions (diameter and length) were selected based on available bone at the implant site.
Primary implant stability was measured immediately after implant placement using resonance frequency analysis, which provides implant stability quotient values as an objective and non-invasive measure of stability. The same measurements were repeated at 3 months and 6 months postoperatively to evaluate changes in stability over time, reflecting the transition from primary mechanical stability to secondary biological stability during osseointegration.
Peri-implant marginal bone levels were assessed using standardized intraoral periapical radiographs obtained using a paralleling technique with grid calibration. Mesial and distal bone levels were measured relative to the implant platform at baseline, 3 months, and 6 months. These measurements were used to evaluate bone remodeling and marginal bone loss during the early healing phase.
All patients were followed up at regular intervals to monitor clinical healing, implant stability, and peri-implant tissue health. Postoperative care and follow-up protocols were standardized for all participants to minimize variability. Radiographic measurements were performed twice by the same examiner to ensure consistency, and intra-examiner reliability was evaluated.
The primary objective of the study was to compare implant stability between the two implant designs over time. The secondary objective was to evaluate and compare peri-implant marginal bone changes associated with each implant design during early healing.
The underlying hypothesis of the study was that triple-threaded conical-body implants would demonstrate superior implant stability due to enhanced mechanical engagement and compressive force distribution, while both implant designs would show comparable peri-implant bone response within clinically acceptable limits.
The results of this study are expected to contribute to the existing body of clinical evidence regarding the role of implant macro-design in influencing stability and bone preservation. This information may assist clinicians in selecting appropriate implant systems based on clinical requirements, thereby improving treatment outcomes and long-term success in implant dentistry.
- Being tested
- Double-threaded straight-body dental implant, Triple-threaded conical-body dental implant
- Keywords
- Implants, Implant Stability Quotient (ISQ), Thread design, Conical implants, Marginal bone loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-threaded straight-body dental implantDevice
Placement of double-threaded, straight-body dental implants (Dentium Narrow ridge (NR)- Line) made of commercially pure titanium with an SLA surface. Implants were placed using a standardized two-stage surgical protocol in the posterior mandibular region. Implant stability and peri-implant marginal bone levels were assessed at baseline, 3 months, and 6 months.
Triple-threaded conical-body dental implantDevice
Placement of triple-threaded, conical-body dental implants (Make it simple (MIS) Lance+) made of commercially pure titanium with a sandblasted and acid-etched surface. Implants were placed using the same standardized two-stage surgical protocol in the posterior mandibular region. Implant stability and peri-implant marginal bone levels were evaluated at baseline, 3 months, and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Double-threaded straight-body implant group | Experimental | Participants in this arm received double-threaded, straight-body dental implants placed using a standardized two-stage surgical protocol. Implant stability (ISQ) and peri-implant marginal bone levels were assessed at baseline, 3 months, and 6 months to evaluate clinical performance during the early healing phase. Receives: Device: Double-threaded straight-body dental implant |
| Triple-threaded conical-body implant group | Experimental | Participants in this arm received triple-threaded, conical-body dental implants. Implant placement was carried out following the same standardized two-stage surgical protocol. Implant stability and peri-implant marginal bone levels were assessed at baseline, 3 months, and 6 months. Receives: Device: Triple-threaded conical-body dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Stability Quotient
Implant stability was measured using resonance frequency analysis and expressed as implant stability quotient values to evaluate the primary and secondary stability of dental implants.
Measured: Baseline (immediately after implant placement), 3 months, and 6 months
Secondary outcomes (2)
Peri-implant marginal bone height
Assessment of mesial and distal marginal bone levels around the implant was performed using standardized intraoral periapical radiographs to evaluate bone changes over time.
Measured: Baseline, 3 months, and 6 months
Marginal bone loss
Measurement of changes in peri-implant bone height was calculated as the difference between baseline and follow-up bone levels at mesial and distal aspects.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start20 Jun 2022
- Primary completion22 Jul 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Partially Edentulous PatientsStudies 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
- Participants were randomly assigned into two parallel groups using a computer-generated randomization method. Group A received double-threaded straight-body implants, while Group B received triple-threaded conical-body implants. Each participant received only one type of implant, and outcomes were assessed at baseline, 3 months, and 6 months without crossover between groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Career Postgraduate Institute of Dental Science and Hospital Lucknow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shyamolima Hazarika, Career Postgraduate Institute of Dental Science and Hospital Lucknow
- Investigators
- Kaushik Pandey, MDS, Study chair, Career Postgraduate Institute of Dental Science and Hospital, Lucknow, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557836
- Sponsor's protocol ID
- CPGIDSH/22/385
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including demographic details (age, sex), implant characteristics (type, size), implant stability quotient values recorded at baseline, 3 months, and 6 months, and peri-implant marginal bone measurements (mesial and distal bone levels and calculated bone loss) at corresponding time points, will be shared.
Publications
Ayub FA, Sunarso S, Dewi RS. The Influence of Implant Macro-geometry in Primary Stability in Low-Density Bone: An in vitro Study. J Int Soc Prev Community Dent. 2025 Apr 30;15(2):134-143. doi: 10.4103/jispcd.jispcd_155_24. eCollection 2025 Mar-Apr.
PubMed 40433430Yamaguchi Y, Shiota M, Fujii M, Shimogishi M, Munakata M. Effects of implant thread design on primary stability-a comparison between single- and double-threaded implants in an artificial bone model. Int J Implant Dent. 2020 Aug 20;6(1):42. doi: 10.1186/s40729-020-00239-1.
PubMed 32815046
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study to Evaluate Implant Stability and Peri-Implant Marginal Bone Loss Around Two Different Thread and Body Designs of Implants at Specified Time Intervals - An In Vivo Study
- ClinicalTrials.gov ID
- NCT07557836
- Acronym / sponsor ID
- CPGIDSH/22/385
- Keywords
- Implants, Implant Stability Quotient (ISQ), Thread design, Conical implants, Marginal bone loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Career Postgraduate Institute of Dental Science and Hospital LucknowUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 29 Apr 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.
This clinical study was conducted to evaluate the effect of different dental implant designs on implant stability and peri-implant bone levels during the early healing phase. Dental implants are widely used for the replacement of missing teeth, and their long-term success depends on achieving adequate primary stability and maintaining the surrounding bone. Variations in implant design, including thread configuration and body geometry, may influence the mechanical and biological behavior of implants, thereby affecting treatment outcomes.
The purpose of this study was to compare two different implant designs: double-threaded straight-body implants and triple-threaded conical-body implants. A total of 30 patients requiring implant-supported restorations in the posterior mandibular region were included in the study. Participants were randomly allocated into two groups, with each group receiving one type of implant design.
Implant stability was assessed using resonance frequency analysis (RFA), which provides implant stability quotient (ISQ) values as an objective measure of stability. In addition, peri-implant marginal bone levels were evaluated using standardized intraoral radiographs. These measurements were recorded at three time points: at the time of implant placement (baseline), at 3 months, and at 6 months after placement.
The primary objective of the study was to determine whether implant design influences implant stability over time. The secondary objective was to evaluate and compare marginal bone loss around the implants between the two groups during the early healing period.
The main research question addressed in this study was: Does the difference in implant thread design and body geometry significantly affect implant stability and peri-implant marginal bone loss during the early healing phase?
It was hypothesized that implants with a conical body design and multiple thread configuration may provide higher stability due to improved bone engagement and load distribution, while maintaining comparable bone levels around the implant.
The findings of this study are expected to provide clinically relevant evidence regarding the influence of implant macro-design on treatment outcomes. This may assist dental practitioners in selecting appropriate implant systems to enhance primary stability, promote successful osseointegration, and improve long-term prognosis in implant therapy.
Detailed description
Dental implants have become a widely accepted and predictable treatment modality for the rehabilitation of partially and completely edentulous patients. The long-term success of dental implants is primarily dependent on achieving and maintaining adequate implant stability and preserving peri-implant bone levels. Implant stability is influenced by several factors, including bone quality, surgical technique, and implant design. Among these, implant macro-design-particularly thread configuration and body geometry-plays a critical role in determining primary stability and stress distribution at the bone-implant interface.
Implant designs vary in terms of thread pitch, depth, and number of threads, as well as body shape (straight/cylindrical versus tapered/conical). Conical implants are believed to enhance primary stability by generating compressive forces within the surrounding bone, especially in areas of low bone density. Similarly, multiple-thread configurations may increase bone-to-implant contact and improve insertion efficiency and mechanical engagement. However, the combined influence of thread design and implant body geometry on implant stability and peri-implant bone behavior remains an area requiring further clinical investigation.
The present study was designed as a randomized, prospective interventional clinical trial with a parallel-group design to evaluate and compare implant stability and peri-implant marginal bone loss between two implant systems with different macro-design characteristics. A total of 30 patients requiring implant-supported restoration in the posterior mandibular region were included. Participants were randomly assigned into two groups using a computer-generated randomization method to ensure unbiased allocation.
Group A received double-threaded straight-body implants, while group B received triple-threaded conical-body implants. All implant placements were performed under standardized clinical conditions using a two-stage surgical protocol. Preoperative clinical and radiographic assessments were carried out to determine bone quality, quantity, and suitability for implant placement. Implant dimensions (diameter and length) were selected based on available bone at the implant site.
Primary implant stability was measured immediately after implant placement using resonance frequency analysis, which provides implant stability quotient values as an objective and non-invasive measure of stability. The same measurements were repeated at 3 months and 6 months postoperatively to evaluate changes in stability over time, reflecting the transition from primary mechanical stability to secondary biological stability during osseointegration.
Peri-implant marginal bone levels were assessed using standardized intraoral periapical radiographs obtained using a paralleling technique with grid calibration. Mesial and distal bone levels were measured relative to the implant platform at baseline, 3 months, and 6 months. These measurements were used to evaluate bone remodeling and marginal bone loss during the early healing phase.
All patients were followed up at regular intervals to monitor clinical healing, implant stability, and peri-implant tissue health. Postoperative care and follow-up protocols were standardized for all participants to minimize variability. Radiographic measurements were performed twice by the same examiner to ensure consistency, and intra-examiner reliability was evaluated.
The primary objective of the study was to compare implant stability between the two implant designs over time. The secondary objective was to evaluate and compare peri-implant marginal bone changes associated with each implant design during early healing.
The underlying hypothesis of the study was that triple-threaded conical-body implants would demonstrate superior implant stability due to enhanced mechanical engagement and compressive force distribution, while both implant designs would show comparable peri-implant bone response within clinically acceptable limits.
The results of this study are expected to contribute to the existing body of clinical evidence regarding the role of implant macro-design in influencing stability and bone preservation. This information may assist clinicians in selecting appropriate implant systems based on clinical requirements, thereby improving treatment outcomes and long-term success in implant dentistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned into two parallel groups using a computer-generated randomization method. Group A received double-threaded straight-body implants, while Group B received triple-threaded conical-body implants. Each participant received only one type of implant, and outcomes were assessed at baseline, 3 months, and 6 months without crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Double-threaded straight-body implant group | Experimental | Device: Double-threaded straight-body dental implantParticipants in this arm received double-threaded, straight-body dental implants placed using a standardized two-stage surgical protocol. Implant stability (ISQ) and peri-implant marginal bone levels were assessed at baseline, 3 months, and 6 months to evaluate clinical performance during the early healing phase. |
| Triple-threaded conical-body implant group | Experimental | Device: Triple-threaded conical-body dental implantParticipants in this arm received triple-threaded, conical-body dental implants. Implant placement was carried out following the same standardized two-stage surgical protocol. Implant stability and peri-implant marginal bone levels were assessed at baseline, 3 months, and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged 18 years and above
- Patients with missing mandibular premolars or molars requiring implant-supported restoration
- Presence of adequate bone volume and density at the implant site for proper implant placement
- Patients with good general health and no systemic conditions affecting healing
- Patients maintaining satisfactory oral hygiene
Key exclusion criteria (8 listed)
- Patients with active infection or pathology at the implant site
- Patients with insufficient bone quality or volume for implant placement
- Patients with systemic diseases or conditions that may impair healing
- Patients with a history of bleeding disorders or on anticoagulant therapy
- Immunocompromised or medically compromised patients
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 |
|---|---|---|
| Double-threaded straight-body dental implantPlacement of double-threaded, straight-body dental implants (Dentium Narrow ridge (NR)- Line) made of commercially pure titanium with an SLA surface. Implants were placed using a standardized two-stage surgical protocol in the posterior mandibular region. Implant stability and peri-implant marginal bone levels were assessed at baseline, 3 months, and 6 months. | Device | Double-threaded straight-body implant group |
| Triple-threaded conical-body dental implantPlacement of triple-threaded, conical-body dental implants (Make it simple (MIS) Lance+) made of commercially pure titanium with a sandblasted and acid-etched surface. Implants were placed using the same standardized two-stage surgical protocol in the posterior mandibular region. Implant stability and peri-implant marginal bone levels were evaluated at baseline, 3 months, and 6 months. | Device | Triple-threaded conical-body implant group |
Primary outcome
Implant Stability Quotient
Time frame: Baseline (immediately after implant placement), 3 months, and 6 months
Implant stability was measured using resonance frequency analysis and expressed as implant stability quotient values to evaluate the primary and secondary stability of dental implants.
2 secondary outcomes
Peri-implant marginal bone height
Time frame: Baseline, 3 months, and 6 months
Marginal bone loss
Time frame: 3 months and 6 months
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 5 May 2026.
- Background: PubMed 40433430Ayub FA, Sunarso S, Dewi RS. The Influence of Implant Macro-geometry in Primary Stability in Low-Density Bone: An in vitro Study. J Int Soc Prev Community Dent. 2025 Apr 30;15(2):134-143. doi: 10.4103/jispcd.jispcd_155_24. eCollection 2025 Mar-Apr.
- Background: PubMed 32815046Yamaguchi Y, Shiota M, Fujii M, Shimogishi M, Munakata M. Effects of implant thread design on primary stability-a comparison between single- and double-threaded implants in an artificial bone model. Int J Implant Dent. 2020 Aug 20;6(1):42. doi: 10.1186/s40729-020-00239-1.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including demographic details (age, sex), implant characteristics (type, size), implant stability quotient values recorded at baseline, 3 months, and 6 months, and peri-implant marginal bone measurements (mesial and distal bone levels and calculated bone loss) at corresponding time points, will be shared.
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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.
Kaushik Pandey, MDS study chair
Career Postgraduate Institute of Dental Science and Hospital, Lucknow, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double-threaded straight-body dental implant and Triple-threaded conical-body dental implant in people with Partially Edentulous Patients and Implant Stability, run by Career Postgraduate Institute of Dental Science and Hospital Lucknow at 1 site in India.
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 8 inclusion and 8 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 5 May 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 India. 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?
Implant Stability Quotient (time frame: Baseline (immediately after implant placement), 3 months, and 6 months). 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 NCT07557836, which also lists 2 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 5 May 2026.