Gingival RecessionNCT07554625
Volumetric Changes After Free Gingival Graft: Tuberosity vs Palatal Donor Site (VolFGG-TP)
A study testing Free Gingival Graft from Anterior Palatal Donor Site and Free Gingival Graft from Posterior Palatal / Tuberosity Donor Site in people with Gingival Recession and Periodontal Plastic Surgery, run by Hooman Hashemzadeh at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled clinical trial evaluated volumetric changes at recipient and donor sites following free gingival graft (FGG) surgery, comparing two different palatal donor regions. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Periodontal Plastic Surgery
- What is being tested?
- Free Gingival Graft from Anterior Palatal Donor Site and Free Gingival Graft from Posterior Palatal / Tuberosity Donor Site
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 May 2025
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 20 to 40 years (both male and female)
- Presence of Miller Class I gingival recession at mandibular anterior teeth (teeth 31, 32, 41, and 42)
- Systemically healthy (no known systemic diseases)
- Non-smokers
- Adequate oral hygiene
- Able and willing to provide written informed consent and attend follow-up visits
Who cannot join
- Pregnancy or lactation
- Current or past smoking
- Diagnosis of diabetes mellitus
- Use of isotretinoin or similar systemic anti-acne medications
- Inadequate oral hygiene
- Current anticoagulant therapy
- Systemic contraindications to periodontal surgery
- History of previous periodontal surgery at the recipient site
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University, Faculty of Dentistry, Department of Periodontology
Samsun, Samsun, 55270
About this study
Official title: Volumetric Analysis of Recipient and Donor Sites Following Free Gingival Graft Surgery Harvested From Different Palatal Donor Sites: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial evaluated volumetric changes at recipient and donor sites following free gingival graft (FGG) surgery, comparing two different palatal donor regions. Forty systemically healthy non-smoking adults aged 20-40 years with Miller Class I gingival recession defects at the mandibular anterior teeth (teeth 31, 32, 41, and 42) were randomly allocated using a sealed envelope method into two groups based on the donor site: (1) the anterior palatal region (from the distal of the canine to the first molar), and (2) the posterior palatal/tuberosity region (between the first molar and the tuberosity). All grafts were harvested targeting a standardized size of 8x10 mm (80 mm²). Digital intraoral scans (3Shape TRIOS 5) were obtained preoperatively and at 1, 3, and 6 months postoperatively. Volumetric changes at both recipient and donor sites were measured using STL-based superimposition in Exocad software. The aim was to compare time-dependent volumetric change patterns at both the recipient and donor sites between the two donor groups.
Read the detailed description
BACKGROUND:
Free gingival graft (FGG) is a well-established procedure to augment keratinized tissue width and manage gingival recession defects. Despite widespread clinical use, comparative data on volumetric outcomes from different palatal donor sites remain limited, and most existing studies rely on one-dimensional clinical measurements rather than volumetric analysis. Emerging evidence suggests that donor tissue composition may differ between anterior palatal and posterior palatal/tuberosity regions, potentially influencing graft behavior at the recipient site.
STUDY DESIGN:
Single-center, parallel-group, randomized controlled clinical trial with 1:1 allocation via sealed envelope randomization.
INTERVENTION:
All surgical procedures were performed by a single operator under local infiltration anesthesia (Ultracain DS, epinephrine 1:200,000). At the recipient site, a split-thickness recipient bed was prepared and the autogenous free gingival graft was stabilized using five 7-0 polypropylene monofilament sutures. Sutures were removed between days 10-14. At the donor site, no sutures were placed and the wound was left to heal by secondary intention. Grafts were harvested aiming for 8x10 mm dimensions.
OUTCOME ASSESSMENT:
Intraoral scans were acquired at T0 (preoperative baseline), T1 (1 month), T2 (3 months), and T3 (6 months) using a 3Shape TRIOS 5 intraoral scanner and saved as STL files. STL files were superimposed in Exocad using a point-based landmark registration protocol, with three corresponding dental landmarks identified on stable hard-tissue surfaces; each postoperative scan was aligned to the T0 baseline. Recipient and donor regions of interest were isolated. MeshMixer was used for STL preparation, while final volumetric calculations were performed in Exocad and recorded in mm³. To account for unavoidable minor variations in graft dimensions, volumetric data were mathematically normalized to a theoretical standard graft surface area of 80 mm² (8x10 mm).
STATISTICAL ANALYSIS:
Sample size was calculated a priori using G*Power 3.1 (α=0.05, power=0.80, matched-pairs model, effect size dz≈0.69), yielding 20 patients per group (40 total). Analyses were conducted in SPSS v25.0 with significance set at p<0.05. Data distribution was assessed using the Shapiro-Wilk test. Within-group time effects were evaluated using Repeated Measures ANOVA; between-group comparisons at each time point were performed using independent samples t-test. Time × donor-site interaction was analyzed to determine whether volumetric change patterns differed between groups over time.
- Conditions
- Gingival Recession, Periodontal Plastic Surgery
- Being tested
- Free Gingival Graft from Anterior Palatal Donor Site, Free Gingival Graft from Posterior Palatal / Tuberosity Donor Site
- Keywords
- free gingival graft, palatal donor site, volumetric analysis, digital dentistry, intraoral scanner
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Gingival Graft from Anterior Palatal Donor SiteProcedure or surgery
Free gingival graft (FGG) surgery was performed under local infiltration anesthesia (Ultracain DS, epinephrine 1:200,000) by a single experienced operator. At the recipient site, a split-thickness recipient bed was prepared at the buccal aspect of mandibular anterior teeth presenting Miller Class I gingival recession. The autogenous free gingival graft was harvested from the anterior palatal region, defined as the area between the distal aspect of the maxillary canine and the first molar, targeting dimensions of 8 × 10 mm. The graft was secured at the recipient site using five 7-0 polypropylene monofilament sutures. No sutures were placed at the donor site; the wound was left to heal by secondary intention. Sutures at the recipient site were removed between postoperative days 10 and 14. All patients received standardized postoperative instructions and analgesic recommendations.
Free Gingival Graft from Posterior Palatal / Tuberosity Donor SiteProcedure or surgery
Free gingival graft (FGG) surgery was performed under local infiltration anesthesia (Ultracain DS, epinephrine 1:200,000) by a single experienced operator. At the recipient site, a split-thickness recipient bed was prepared at the buccal aspect of mandibular anterior teeth presenting Miller Class I gingival recession. The autogenous free gingival graft was harvested from the maxillary tuberosity / posterior palatal region, targeting dimensions of 8 × 10 mm. The graft was secured at the recipient site using five 7-0 polypropylene monofilament sutures. No sutures were placed at the donor site; the wound was left to heal by secondary intention. Sutures at the recipient site were removed between postoperative days 10 and 14. All patients received standardized postoperative instructions and analgesic recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Anterior Palatal Donor Group | Experimental | Free gingival graft was harvested from the anterior palatal region, defined as the area between the distal of the maxillary canine and the first molar. The graft was targeted to be 8x10 mm (approximately 80 mm²) in dimension. After harvesting, the graft was placed at the recipient site (Miller Class I gingival recession at mandibular anterior teeth 31, 32, 41, 42) and stabilized with five 7-0 polypropylene sutures. The donor site was left to heal by secondary intention without sutures. Receives: Procedure: Free Gingival Graft from Anterior Palatal Donor Site |
| Posterior Palatal / Tuberosity Donor Group | Experimental | Free gingival graft was harvested exclusively from the maxillary tuberosity region. The graft was targeted to be 8x10 mm (approximately 80 mm²) in dimension. After harvesting, the graft was placed at the recipient site (Miller Class I gingival recession at mandibular anterior teeth 31, 32, 41, 42) and stabilized with five 7-0 polypropylene sutures. The donor site was left to heal by secondary intention without sutures. Receives: Procedure: Free Gingival Graft from Posterior Palatal / Tuberosity Donor Site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric change at the recipient site
Standardized volumetric change (mm³) at the recipient site compared with preoperative baseline (T0), measured via three-dimensional STL-based superimposition of intraoral scans (3Shape TRIOS 5) using Exocad software. Volumetric data were mathematically normalized to a theoretical standard graft surface area of 80 mm² (8x10 mm) to account for minor graft size variations. Negative values indicate volume loss; positive values indicate volume gain relative to baseline.
Measured: 1, 3, and 6 months postoperatively
Secondary outcomes (2)
Volumetric change at the donor site
Standardized volumetric change (mm³) at the palatal donor site (either anterior palatal or posterior palatal/tuberosity, as per group allocation) compared with preoperative baseline (T0), measured via three-dimensional STL-based superimposition of intraoral scans (3Shape TRIOS 5) using Exocad software. Negative values indicate volume loss relative to baseline; positive values indicate volume gain relative to baseline.
Measured: 1, 3, and 6 months postoperatively
Time × donor-site interaction effect on volumetric change at the recipient site
Repeated Measures ANOVA interaction term evaluating whether time-dependent volumetric change patterns at the recipient site differ between the two donor groups (anterior palatal versus posterior palatal/tuberosity). A significant interaction (p<0.05) indicates that volumetric change trajectories across time differ between donor groups.
Measured: Across 1, 3, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 Dec 2023
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hooman Hashemzadeh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hooman Hashemzadeh, Ondokuz Mayıs University
- Investigators
- Tugrul Kirtiloglu, PHD, Principal investigator, Ondokuz Mayıs UniversityEmir Akan, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554625
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/569
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parvini P, Galarraga-Vinueza ME, Obreja K, Magini RS, Sader R, Schwarz F. Prospective study assessing three-dimensional changes of mucosal healing following soft tissue augmentation using free gingival grafts. J Periodontol. 2021 Mar;92(3):400-408. doi: 10.1002/JPER.19-0640. Epub 2020 Aug 21.
PubMed 33448379Tavelli L, Barootchi S, Siqueira R, Kauffmann F, Majzoub J, Stefanini M, Zucchelli G, Wang HL. Three-Dimensional Volumetric Analysis of the Palatal Donor Site Following Soft Tissue Harvesting. Int J Periodontics Restorative Dent. 2022 May-Jun;42(3):393-399. doi: 10.11607/prd.5268.
PubMed 35472117Akan E, Hashemzadeh H, Kirtiloglu T. Volumetric comparison of free gingival grafts harvested from palatal versus tuberosity donor sites: a six-month randomised controlled trial using three-dimensional intraoral scanning. Odontology. 2026 Oct 31. doi: 10.1007/s10266-026-01590-2. Online ahead of print.
PubMed 42966784
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Analysis of Recipient and Donor Sites Following Free Gingival Graft Surgery Harvested From Different Palatal Donor Sites: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07554625
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/569
- Conditions
- Gingival Recession, Periodontal Plastic Surgery
- Keywords
- free gingival graft, palatal donor site, volumetric analysis, digital dentistry, intraoral scanner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hooman HashemzadehUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 28 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 randomized controlled clinical trial evaluated volumetric changes at recipient and donor sites following free gingival graft (FGG) surgery, comparing two different palatal donor regions. Forty systemically healthy non-smoking adults aged 20-40 years with Miller Class I gingival recession defects at the mandibular anterior teeth (teeth 31, 32, 41, and 42) were randomly allocated using a sealed envelope method into two groups based on the donor site: (1) the anterior palatal region (from the distal of the canine to the first molar), and (2) the posterior palatal/tuberosity region (between the first molar and the tuberosity). All grafts were harvested targeting a standardized size of 8x10 mm (80 mm²). Digital intraoral scans (3Shape TRIOS 5) were obtained preoperatively and at 1, 3, and 6 months postoperatively. Volumetric changes at both recipient and donor sites were measured using STL-based superimposition in Exocad software. The aim was to compare time-dependent volumetric change patterns at both the recipient and donor sites between the two donor groups.
Detailed description
BACKGROUND:
Free gingival graft (FGG) is a well-established procedure to augment keratinized tissue width and manage gingival recession defects. Despite widespread clinical use, comparative data on volumetric outcomes from different palatal donor sites remain limited, and most existing studies rely on one-dimensional clinical measurements rather than volumetric analysis. Emerging evidence suggests that donor tissue composition may differ between anterior palatal and posterior palatal/tuberosity regions, potentially influencing graft behavior at the recipient site.
STUDY DESIGN:
Single-center, parallel-group, randomized controlled clinical trial with 1:1 allocation via sealed envelope randomization.
INTERVENTION:
All surgical procedures were performed by a single operator under local infiltration anesthesia (Ultracain DS, epinephrine 1:200,000). At the recipient site, a split-thickness recipient bed was prepared and the autogenous free gingival graft was stabilized using five 7-0 polypropylene monofilament sutures. Sutures were removed between days 10-14. At the donor site, no sutures were placed and the wound was left to heal by secondary intention. Grafts were harvested aiming for 8x10 mm dimensions.
OUTCOME ASSESSMENT:
Intraoral scans were acquired at T0 (preoperative baseline), T1 (1 month), T2 (3 months), and T3 (6 months) using a 3Shape TRIOS 5 intraoral scanner and saved as STL files. STL files were superimposed in Exocad using a point-based landmark registration protocol, with three corresponding dental landmarks identified on stable hard-tissue surfaces; each postoperative scan was aligned to the T0 baseline. Recipient and donor regions of interest were isolated. MeshMixer was used for STL preparation, while final volumetric calculations were performed in Exocad and recorded in mm³. To account for unavoidable minor variations in graft dimensions, volumetric data were mathematically normalized to a theoretical standard graft surface area of 80 mm² (8x10 mm).
STATISTICAL ANALYSIS:
Sample size was calculated a priori using G*Power 3.1 (α=0.05, power=0.80, matched-pairs model, effect size dz≈0.69), yielding 20 patients per group (40 total). Analyses were conducted in SPSS v25.0 with significance set at p<0.05. Data distribution was assessed using the Shapiro-Wilk test. Within-group time effects were evaluated using Repeated Measures ANOVA; between-group comparisons at each time point were performed using independent samples t-test. Time × donor-site interaction was analyzed to determine whether volumetric change patterns differed between groups over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Palatal Donor Group | Experimental | Procedure: Free Gingival Graft from Anterior Palatal Donor SiteFree gingival graft was harvested from the anterior palatal region, defined as the area between the distal of the maxillary canine and the first molar. The graft was targeted to be 8x10 mm (approximately 80 mm²) in dimension. After harvesting, the graft was placed at the recipient site (Miller Class I gingival recession at mandibular anterior teeth 31, 32, 41, 42) and stabilized with five 7-0 polypropylene sutures. The donor site was left to heal by secondary intention without sutures. |
| Posterior Palatal / Tuberosity Donor Group | Experimental | Procedure: Free Gingival Graft from Posterior Palatal / Tuberosity Donor SiteFree gingival graft was harvested exclusively from the maxillary tuberosity region. The graft was targeted to be 8x10 mm (approximately 80 mm²) in dimension. After harvesting, the graft was placed at the recipient site (Miller Class I gingival recession at mandibular anterior teeth 31, 32, 41, 42) and stabilized with five 7-0 polypropylene sutures. The donor site was left to heal by secondary intention without sutures. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 20 to 40 years (both male and female)
- Presence of Miller Class I gingival recession at mandibular anterior teeth (teeth 31, 32, 41, and 42)
- Systemically healthy (no known systemic diseases)
- Non-smokers
- Adequate oral hygiene
Key exclusion criteria (8 listed)
- Pregnancy or lactation
- Current or past smoking
- Diagnosis of diabetes mellitus
- Use of isotretinoin or similar systemic anti-acne medications
- Inadequate oral hygiene
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 |
|---|---|---|
| Free Gingival Graft from Anterior Palatal Donor SiteFree gingival graft (FGG) surgery was performed under local infiltration anesthesia (Ultracain DS, epinephrine 1:200,000) by a single experienced operator. At the recipient site, a split-thickness recipient bed was prepared at the buccal aspect of mandibular anterior teeth presenting Miller Class I gingival recession. The autogenous free gingival graft was harvested from the anterior palatal region, defined as the area between the distal aspect of the maxillary canine and the first molar, targeting dimensions of 8 × 10 mm. The graft was secured at the recipient site using five 7-0 polypropylene monofilament sutures. No sutures were placed at the donor site; the wound was left to heal by secondary intention. Sutures at the recipient site were removed between postoperative days 10 and 14. All patients received standardized postoperative instructions and analgesic recommendations. | Procedure or surgery | Anterior Palatal Donor Group |
| Free Gingival Graft from Posterior Palatal / Tuberosity Donor SiteFree gingival graft (FGG) surgery was performed under local infiltration anesthesia (Ultracain DS, epinephrine 1:200,000) by a single experienced operator. At the recipient site, a split-thickness recipient bed was prepared at the buccal aspect of mandibular anterior teeth presenting Miller Class I gingival recession. The autogenous free gingival graft was harvested from the maxillary tuberosity / posterior palatal region, targeting dimensions of 8 × 10 mm. The graft was secured at the recipient site using five 7-0 polypropylene monofilament sutures. No sutures were placed at the donor site; the wound was left to heal by secondary intention. Sutures at the recipient site were removed between postoperative days 10 and 14. All patients received standardized postoperative instructions and analgesic recommendations. | Procedure or surgery | Posterior Palatal / Tuberosity Donor Group |
Primary outcome
Volumetric change at the recipient site
Time frame: 1, 3, and 6 months postoperatively
Standardized volumetric change (mm³) at the recipient site compared with preoperative baseline (T0), measured via three-dimensional STL-based superimposition of intraoral scans (3Shape TRIOS 5) using Exocad software. Volumetric data were mathematically normalized to a theoretical standard graft surface area of 80 mm² (8x10 mm) to account for minor graft size variations. Negative values indicate volume loss; positive values indicate volume gain relative to baseline.
2 secondary outcomes
Volumetric change at the donor site
Time frame: 1, 3, and 6 months postoperatively
Time × donor-site interaction effect on volumetric change at the recipient site
Time frame: Across 1, 3, and 6 months postoperatively
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 13 Aug 2026.
- Background: PubMed 33448379Parvini P, Galarraga-Vinueza ME, Obreja K, Magini RS, Sader R, Schwarz F. Prospective study assessing three-dimensional changes of mucosal healing following soft tissue augmentation using free gingival grafts. J Periodontol. 2021 Mar;92(3):400-408. doi: 10.1002/JPER.19-0640. Epub 2020 Aug 21.
- Background: PubMed 35472117Tavelli L, Barootchi S, Siqueira R, Kauffmann F, Majzoub J, Stefanini M, Zucchelli G, Wang HL. Three-Dimensional Volumetric Analysis of the Palatal Donor Site Following Soft Tissue Harvesting. Int J Periodontics Restorative Dent. 2022 May-Jun;42(3):393-399. doi: 10.11607/prd.5268.
- Derived from this study: PubMed 42966784Akan E, Hashemzadeh H, Kirtiloglu T. Volumetric comparison of free gingival grafts harvested from palatal versus tuberosity donor sites: a six-month randomised controlled trial using three-dimensional intraoral scanning. Odontology. 2026 Oct 31. doi: 10.1007/s10266-026-01590-2. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Tugrul Kirtiloglu, PHD principal investigator
Ondokuz Mayıs University
Emir Akan study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free Gingival Graft from Anterior Palatal Donor Site and Free Gingival Graft from Posterior Palatal / Tuberosity Donor Site in people with Gingival Recession and Periodontal Plastic Surgery, run by Hooman Hashemzadeh at 1 site in Turkey (Türkiye).
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 6 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 13 Aug 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 Turkey (Türkiye). 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?
Volumetric change at the recipient site (time frame: 1, 3, and 6 months postoperatively). 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 NCT07554625, which also lists 3 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 13 Aug 2026.