Peri-implant Soft Tissue HealingFDAM-CMNCT07647120
Comparison of Freeze-Dried Amniotic and Collagen Membranes for Soft Tissue Healing After Grafted Implant Surgery
A study testing Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM) in people with Peri-implant Soft Tissue Healing, run by RAJAS DENTAL COLLEGE AND HOSPITAL at 1 site in India.
Trial summary
The goal of this clinical trial is to learn whether Freeze-Dried Amniotic Membrane (FD-AM) or Collagen Membrane (CM) provides better soft tissue healing after Stage I dental implant surgery with particulate bone grafting in adults requiring implant treatment in bilateral posterior maxillary edentulous sites. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Peri-implant Soft Tissue Healing
- What is being tested?
- Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- 19 Jun 2025to 18 Feb 2026
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 25-55 years.
- Male and female participants.
- Bilateral posterior maxillary edentulous area in the premolar region (Bedrossian Zone 2 classification).
- Patients with teeth requiring extraction and eligible for immediate implant placement in the bilateral posterior maxillary region.
- Patients with ridge defects classified as Siebert Class II or Class III and eligible for delayed implant placement in the bilateral posterior maxillary region.
Who cannot join
- Current smokers.
- History of systemic diseases affecting bone turnover, including hyperthyroidism (T4 outside 5.0-12.0 μg/dL or T3 outside 80-220 ng/dL), Type I diabetes mellitus (HbA1c > 6%), Cushing's disease, or hyperlipidemia.
- Pregnant women.
- Lactating mothers.
- Presence of periodontal disease.
- Known allergy to study materials or medications.
- Blood-borne infectious diseases, including HIV or HBsAg positivity.
- Vitamin D level < 30 ng/mL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM) in Soft Tissue Healing After Stage 1 Implant Surgery With Particulate Grafting: An In Vivo Study
The goal of this clinical trial is to learn whether Freeze-Dried Amniotic Membrane (FD-AM) or Collagen Membrane (CM) provides better soft tissue healing after Stage I dental implant surgery with particulate bone grafting in adults requiring implant treatment in bilateral posterior maxillary edentulous sites. It will also evaluate postoperative pain associated with the two membrane types.
The main questions it aims to answer are:
Read more
Does FD-AM result in improved early soft tissue healing compared with CM as assessed by the Early Healing Score (EHS)? Does FD-AM reduce postoperative pain compared with CM as assessed by the Visual Analogue Scale (VAS)?
Researchers will compare FD-AM and CM placed over grafted implant sites to determine whether one membrane provides superior healing outcomes and patient comfort.
Participants will:
Undergo Stage I implant surgery with particulate bone grafting. Receive FD-AM at one implant site and CM at the contralateral implant site according to the study randomization protocol.
Attend follow-up visits for assessment of soft tissue healing and postoperative pain.
Complete questionnaires related to pain and healing outcomes during the postoperative period.
Read the detailed description
This prospective interventional in vivo study was conducted in the Department of Advanced Dental Sciences, Rajas Dental College and Hospital, to compare the effectiveness of Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM) in promoting soft tissue healing following Stage I implant surgery with particulate bone grafting.
A total of 10 partially edentulous patients with bilateral posterior maxillary edentulous sites meeting the predefined inclusion and exclusion criteria were recruited. The study employed a split-mouth design in which each patient contributed two implant sites, allowing direct within-patient comparison of the two membrane types. One site received FD-AM and the contralateral site received CM according to a randomization protocol based on a simple coin toss performed by an independent individual not involved in surgery or outcome assessment.
The study included patients aged 25-55 years presenting with bilateral posterior maxillary edentulous areas, immediate implant placement requirements following extraction, or delayed implant placement in ridge defects requiring grafting. Patients with smoking history, pregnancy, systemic diseases affecting bone metabolism, active periodontal disease, infectious diseases, vitamin D deficiency, or known allergies to study materials were excluded.
All surgical procedures were performed under aseptic conditions using standard implant surgical protocols. Following implant placement, xenogeneic demineralized bone matrix graft material (Osseograft) was placed around the implant site as required. Platelet-Rich Fibrin (PRF) was prepared from autologous venous blood and used to enhance the regenerative environment. Barrier membranes were adapted over the grafted sites to facilitate guided bone regeneration and were followed by primary wound closure using interrupted sutures.
The primary outcome measure was soft tissue healing assessed using the Early Healing Score (EHS) by a blinded examiner. Secondary outcome assessment included postoperative pain evaluation using a Visual Analogue Scale (VAS) and structured questionnaires administered during follow-up visits.
The study aimed to determine whether FD-AM provides comparable or superior soft tissue healing compared with conventional collagen membranes. The results demonstrated favorable healing responses with both membrane types, characterized by adequate hemostasis, absence of significant inflammatory signs, and satisfactory epithelialization during the early healing period. The findings suggest that both FD-AM and CM are effective barrier membranes for supporting early soft tissue healing and guided bone regeneration around dental implants.
- Conditions
- Peri-implant Soft Tissue Healing
- Being tested
- Freeze-Dried Amniotic Membrane (FD-AM), Collagen Membrane (CM)
- Keywords
- Freeze-dried amniotic membrane, Collagen membrane, Dental implants, Early Healing Score, Visual Analog Scale, Amniotic Membrane, Collagen Barrier Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-Dried Amniotic Membrane (FD-AM)Device
Also called Amniotic Membrane FD-AM
Freeze-Dried Amniotic Membrane (FD-AM) was placed over the particulate bone grafted implant site following Stage I implant surgery. The membrane was trimmed and adapted to cover the grafted area, serving as a barrier membrane for guided bone regeneration and promoting soft tissue healing during the postoperative period.
Collagen Membrane (CM)Device
Also called Collagen Barrier Membrane CM
Collagen Membrane (CM) was placed over the particulate bone grafted implant site following Stage I implant surgery. The membrane was trimmed and adapted to cover the grafted area, serving as a barrier membrane for guided bone regeneration and supporting soft tissue healing during the postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| Freeze-Dried Amniotic Membrane (FD-AM) Group | Experimental | Participants underwent Stage I implant surgery with particulate bone grafting at the implant site. Following graft placement, a Freeze-Dried Amniotic Membrane (FD-AM) was adapted and placed over the grafted area to facilitate guided bone regeneration and enhance soft tissue healing. Postoperative healing was evaluated using the Early Healing Score (EHS) and Visual Analogue Scale (VAS). Receives: Device: Freeze-Dried Amniotic Membrane (FD-AM) |
| Collagen Membrane (CM) Group | Experimental | Participants underwent Stage I implant surgery with particulate bone grafting at the implant site. Following graft placement, a Collagen Membrane (CM) was adapted and placed over the grafted area to facilitate guided bone regeneration and support soft tissue healing. Postoperative healing was evaluated using the Early Healing Score (EHS) and Visual Analogue Scale (VAS). Receives: Device: Collagen Membrane (CM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Healing Score
Assessment and comparison of soft tissue healing around bone-grafted implant sites covered with Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM) following Stage I implant surgery using the Early Healing Score (EHS). The EHS evaluates wound healing based on three clinical parameters:
Clinical Signs of Re-epithelialization (CSR): 0 = visible distance between incision margins; 3 = incision margins in contact; 6 = merged incision margins.
Clinical Signs of Haemostasis (CSH): 0 = bleeding at incision margins; 1 = presence of fibrin ; 2 = absence of fibrin. Clinical Signs of Inflammation (CSI): 0 = redness involving >50% of incision length and/or pronounced swelling; 1 = redness involving <50% of incision length; 2 = absence of redness along incision length.
The EHS is calculated as the sum of CSR, CSH, and CSI scores , where 0 represents the poorest healing and 10 represents ideal wound healing. Higher scores indicate better soft tissue healing outcomes.
Measured: 1 week and 2 weeks
Secondary outcomes (1)
Postoperative Pain Assessment Using Visual Analogue Scale (VAS)
Assessment and comparison of postoperative pain at bone-grafted implant sites covered with Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM) using the Visual Analog Scale (VAS). Participants rate pain intensity on a scale from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate greater pain severity and a worse outcome.
Measured: 1 week and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start19 Jun 2025
- Primary completion27 Jan 2026
- Study completion18 Feb 2026
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 Peri-implant Soft Tissue HealingStudies 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
- Crossover
- Model description
- This study employed a randomized split-mouth crossover design in which each participant contributed two bilateral posterior implant sites. Following implant placement and particulate bone grafting, one site received Freeze-Dried Amniotic Membrane (FD-AM) and the contralateral site received Collagen Membrane (CM) according to a simple coin-toss randomization protocol. This design allowed each participant to serve as their own control, minimizing inter-individual variability and enabling direct comparison of soft tissue healing and postoperative pain outcomes between the two membrane types.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAJAS DENTAL COLLEGE AND HOSPITAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex M Muruppel, MDS, Study chair, RAJAS DENTAL COLLEGE AND HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647120
- Sponsor's protocol ID
- RDCH/PRL/IEC/D-0138/2024
- Other IDs
- RDCH/PRL/IEC/D-0138/2024
- Acronym
- FDAM-CM
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared because the study was conducted as part of an academic postgraduate research project, and no formal data-sharing plan was established. Participant confidentiality and privacy will be maintained in accordance with institutional ethics requirements.
Publications
Velez I, Parker WB, Siegel MA, Hernandez M. Cryopreserved amniotic membrane for modulation of periodontal soft tissue healing: a pilot study. J Periodontol. 2010 Dec;81(12):1797-804. doi: 10.1902/jop.2010.100060. Epub 2010 Jul 14.
PubMed 20629549Agrawal E, Chopra R, Gupta SJ, Sharma N, Khan F, Gupta N. Comparative evaluation of the efficacy of amniotic membrane with collagen membrane along with demineralized freeze-dried bone allograft in the treatment of periodontal intrabony defects - A clinico-radiographic study. J Indian Soc Periodontol. 2022 Sep-Oct;26(5):458-464. doi: 10.4103/jisp.jisp_305_21. Epub 2022 Sep 1.
PubMed 36339389
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM) in Soft Tissue Healing After Stage 1 Implant Surgery With Particulate Grafting: An In Vivo Study
- ClinicalTrials.gov ID
- NCT07647120
- Acronym / sponsor ID
- FDAM-CM / RDCH/PRL/IEC/D-0138/2024
- Conditions
- Peri-implant Soft Tissue Healing
- Keywords
- Freeze-dried amniotic membrane, Collagen membrane, Dental implants, Early Healing Score, Visual Analog Scale, Amniotic Membrane, Collagen Barrier Membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- RAJAS DENTAL COLLEGE AND HOSPITALUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 15 Jun 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.
The goal of this clinical trial is to learn whether Freeze-Dried Amniotic Membrane (FD-AM) or Collagen Membrane (CM) provides better soft tissue healing after Stage I dental implant surgery with particulate bone grafting in adults requiring implant treatment in bilateral posterior maxillary edentulous sites. It will also evaluate postoperative pain associated with the two membrane types.
The main questions it aims to answer are:
Does FD-AM result in improved early soft tissue healing compared with CM as assessed by the Early Healing Score (EHS)? Does FD-AM reduce postoperative pain compared with CM as assessed by the Visual Analogue Scale (VAS)?
Researchers will compare FD-AM and CM placed over grafted implant sites to determine whether one membrane provides superior healing outcomes and patient comfort.
Participants will:
Undergo Stage I implant surgery with particulate bone grafting. Receive FD-AM at one implant site and CM at the contralateral implant site according to the study randomization protocol.
Attend follow-up visits for assessment of soft tissue healing and postoperative pain.
Complete questionnaires related to pain and healing outcomes during the postoperative period.
Detailed description
This prospective interventional in vivo study was conducted in the Department of Advanced Dental Sciences, Rajas Dental College and Hospital, to compare the effectiveness of Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM) in promoting soft tissue healing following Stage I implant surgery with particulate bone grafting.
A total of 10 partially edentulous patients with bilateral posterior maxillary edentulous sites meeting the predefined inclusion and exclusion criteria were recruited. The study employed a split-mouth design in which each patient contributed two implant sites, allowing direct within-patient comparison of the two membrane types. One site received FD-AM and the contralateral site received CM according to a randomization protocol based on a simple coin toss performed by an independent individual not involved in surgery or outcome assessment.
The study included patients aged 25-55 years presenting with bilateral posterior maxillary edentulous areas, immediate implant placement requirements following extraction, or delayed implant placement in ridge defects requiring grafting. Patients with smoking history, pregnancy, systemic diseases affecting bone metabolism, active periodontal disease, infectious diseases, vitamin D deficiency, or known allergies to study materials were excluded.
All surgical procedures were performed under aseptic conditions using standard implant surgical protocols. Following implant placement, xenogeneic demineralized bone matrix graft material (Osseograft) was placed around the implant site as required. Platelet-Rich Fibrin (PRF) was prepared from autologous venous blood and used to enhance the regenerative environment. Barrier membranes were adapted over the grafted sites to facilitate guided bone regeneration and were followed by primary wound closure using interrupted sutures.
The primary outcome measure was soft tissue healing assessed using the Early Healing Score (EHS) by a blinded examiner. Secondary outcome assessment included postoperative pain evaluation using a Visual Analogue Scale (VAS) and structured questionnaires administered during follow-up visits.
The study aimed to determine whether FD-AM provides comparable or superior soft tissue healing compared with conventional collagen membranes. The results demonstrated favorable healing responses with both membrane types, characterized by adequate hemostasis, absence of significant inflammatory signs, and satisfactory epithelialization during the early healing period. The findings suggest that both FD-AM and CM are effective barrier membranes for supporting early soft tissue healing and guided bone regeneration around dental implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study employed a randomized split-mouth crossover design in which each participant contributed two bilateral posterior implant sites. Following implant placement and particulate bone grafting, one site received Freeze-Dried Amniotic Membrane (FD-AM) and the contralateral site received Collagen Membrane (CM) according to a simple coin-toss randomization protocol. This design allowed each participant to serve as their own control, minimizing inter-individual variability and enabling direct comparison of soft tissue healing and postoperative pain outcomes between the two membrane types.
| Arm | Type | Receives |
|---|---|---|
| Freeze-Dried Amniotic Membrane (FD-AM) Group | Experimental | Device: Freeze-Dried Amniotic Membrane (FD-AM)Participants underwent Stage I implant surgery with particulate bone grafting at the implant site. Following graft placement, a Freeze-Dried Amniotic Membrane (FD-AM) was adapted and placed over the grafted area to facilitate guided bone regeneration and enhance soft tissue healing. Postoperative healing was evaluated using the Early Healing Score (EHS) and Visual Analogue Scale (VAS). |
| Collagen Membrane (CM) Group | Experimental | Device: Collagen Membrane (CM)Participants underwent Stage I implant surgery with particulate bone grafting at the implant site. Following graft placement, a Collagen Membrane (CM) was adapted and placed over the grafted area to facilitate guided bone regeneration and support soft tissue healing. Postoperative healing was evaluated using the Early Healing Score (EHS) and Visual Analogue Scale (VAS). |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 25-55 years.
- Male and female participants.
- Bilateral posterior maxillary edentulous area in the premolar region (Bedrossian Zone 2 classification).
- Patients with teeth requiring extraction and eligible for immediate implant placement in the bilateral posterior maxillary region.
- Patients with ridge defects classified as Siebert Class II or Class III and eligible for delayed implant placement in the bilateral posterior maxillary region.
Key exclusion criteria (8 listed)
- Current smokers.
- History of systemic diseases affecting bone turnover, including hyperthyroidism (T4 outside 5.0-12.0 μg/dL or T3 outside 80-220 ng/dL), Type I diabetes mellitus (HbA1c > 6%), Cushing's disease, or hyperlipidemia.
- Pregnant women.
- Lactating mothers.
- Presence of periodontal disease.
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 |
|---|---|---|
| Freeze-Dried Amniotic Membrane (FD-AM)Also: Amniotic Membrane FD-AMFreeze-Dried Amniotic Membrane (FD-AM) was placed over the particulate bone grafted implant site following Stage I implant surgery. The membrane was trimmed and adapted to cover the grafted area, serving as a barrier membrane for guided bone regeneration and promoting soft tissue healing during the postoperative period. | Device | Freeze-Dried Amniotic Membrane (FD-AM) Group |
| Collagen Membrane (CM)Also: Collagen Barrier Membrane CMCollagen Membrane (CM) was placed over the particulate bone grafted implant site following Stage I implant surgery. The membrane was trimmed and adapted to cover the grafted area, serving as a barrier membrane for guided bone regeneration and supporting soft tissue healing during the postoperative period. | Device | Collagen Membrane (CM) Group |
Primary outcome
Early Healing Score
Time frame: 1 week and 2 weeks
Assessment and comparison of soft tissue healing around bone-grafted implant sites covered with Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM) following Stage I implant surgery using the Early Healing Score (EHS). The EHS evaluates wound healing based on three clinical parameters: Clinical Signs of Re-epithelialization (CSR): 0 = visible distance between incision margins; 3 = incision margins in contact; 6 = merged incision margins. Clinical Signs of Haemostasis (CSH): 0 = bleeding at incision margins; 1 = presence of fibrin ; 2 = absence of fibrin. Clinical Signs of Inflammation (CSI): 0 = redness involving >50% of incision length and/or pronounced swelling; 1 = redness involving <50% of incision length; 2 = absence of redness along incision length. The EHS is calculated as the sum of CSR, CSH, and CSI scores , where 0 represents the poorest healing and 10 represents ideal wound healing. Higher scores indicate better soft tissue healing outcomes.
1 secondary outcome
Postoperative Pain Assessment Using Visual Analogue Scale (VAS)
Time frame: 1 week and 2 weeks
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 15 Jun 2026.
- Background: PubMed 20629549Velez I, Parker WB, Siegel MA, Hernandez M. Cryopreserved amniotic membrane for modulation of periodontal soft tissue healing: a pilot study. J Periodontol. 2010 Dec;81(12):1797-804. doi: 10.1902/jop.2010.100060. Epub 2010 Jul 14.
- Background: PubMed 36339389Agrawal E, Chopra R, Gupta SJ, Sharma N, Khan F, Gupta N. Comparative evaluation of the efficacy of amniotic membrane with collagen membrane along with demineralized freeze-dried bone allograft in the treatment of periodontal intrabony defects - A clinico-radiographic study. J Indian Soc Periodontol. 2022 Sep-Oct;26(5):458-464. doi: 10.4103/jisp.jisp_305_21. Epub 2022 Sep 1.
- Cryopreserved amniotic membrane for modulation of periodontal soft tissue healing: a pilot studyLink provided by the sponsor.
- Comparative evaluation of the efficacy of amniotic membrane with collagen membrane along with demineralized freeze-dried bone allograft in the treatment of periodontal intrabony defects - A clinico-radiographic studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared because the study was conducted as part of an academic postgraduate research project, and no formal data-sharing plan was established. Participant confidentiality and privacy will be maintained in accordance with institutional ethics requirements.
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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.
Alex M Muruppel, MDS study chair
RAJAS DENTAL COLLEGE AND HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM) in people with Peri-implant Soft Tissue Healing, run by RAJAS DENTAL COLLEGE AND HOSPITAL 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 5 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 15 Jun 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?
Early Healing Score (time frame: 1 week and 2 weeks). 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 NCT07647120, 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 15 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.