Gingival Recession, LocalizedEarly Phase 1NCT06228534
Root Coverage With Tunneling Technique With Connective Tissue Versus Coronal Advancement Flap Technique.
A Early Phase 1 study testing Root coverage with tunneling technique in people with Gingival Recession, Localized and Gingival Recession, run by Luis Alberto Chauca Bajaña at 1 site in Ecuador.
Trial summary
This is a randomized triple-blind clinical trial. This comparative clinical study investigates the efficacy of root coverage using two periodontal techniques: the tunneling technique and the coronal advancement technique. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Localized, Gingival Recession
- What is being tested?
- Root coverage with tunneling technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEcuador
- Study dates
- 15 Jan 2024to 20 Jun 2025
- Phase
- Early Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking
- No systemic diseases, no pregnancy
- No active periodontal disease
- Bacterial plaque and bleeding Score ≤9%.
- No medication that interferes with periodontal tissue health or scarring.
- Teeth without root canal treatments
Show all 10Show fewer
- No contraindication to periodontal surgery
- Presence of at least one type I and II Miller O RT1 - RT2 recession defect with at least 4 recessions in the upper or lower jaw that clearly shows the amelocementary limit.
- Work will be done on upper central incisors, upper lateral incisors, upper canines and upper premolars.
- For the coronal advancement technique, multiple or unitary gingival recessions will be used
Who cannot join
- SMOKING PATIENT
- PATIENT WITH A SYSTEMIC DISEASE
- WITH PERIODONTAL DISEASE
- GINGIVAL RECESSION CLASS III OR RT3
- PATIENT WITH EDENTULISM
- PATIENT WITHOUT AMELOCEMENTARY LIMIT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Root Coverage With Tunneling Technique With Connective Tissue Versus Coronal Advancement Flap Technique. A 3- and 6-month Follow-up of a Randomized Clinical Trial.
This is a randomized triple-blind clinical trial. This comparative clinical study investigates the efficacy of root coverage using two periodontal techniques: the tunneling technique and the coronal advancement technique. The objective is to evaluate and compare the clinical, esthetic and patient perception outcomes after undergoing each procedure. Participants with specific gingival recessions will be included, and follow-up will be performed to measure root coverage, keratinized tissue gain and other relevant parameters. In addition, a detailed analysis of the morbidity associated with each technique will be performed. This study aims to provide valuable information to guide oral health professionals in choosing the most appropriate technique for the treatment of gingival recessions.
Read the detailed description
Donor area Surgeries were initiated in all participants by removing connective tissue from the mucosa of the palate using the deepithelialized free gingival graft technique.
Receiving area
- TUN + CTG (test group)
Zabalegui et al. detailed the surgical procedure as follows:
The tunnel is created by making a partial-thickness incision in each recession area that will be addressed in the procedure. Special attention is paid to the manipulation of the tissue beyond the mucogingival junction, in order to obtain a tunnel without tension that facilitates the insertion of the graft.
At the level of the interdental papillae, a careful incision is made, raising the papillae gently without separating their tips.
A graft is extracted from the palate that extends from the canine area to the tuberosity, ensuring that it is long enough to cover the root of all the teeth involved.
The graft is inserted into the tunnel using a specific suture technique. The first suture is passed through the most distal part of the recession, and the needle emerges in the most medial part of the recession. The second suture is placed on the opposite side, and the needle emerges in the same medial location of the recession.
The graft, supported by both sutures (mesial and distal), slides smoothly into the tunnel, passing under the interdental papillae. In some cases, specific instruments can help adjust the graft within the tunnel.
Once the graft is in the desired position, both sutures are tied with knots to secure and stabilize the inserted graft. This exposes grafting into the recession area.
CAF + CTG (grupo control) Two beveled incisions were made in a horizontal position, one on the mesial side and one on the distal side of the recession-affected area. These incisions were located at the bases of the papillae and distanced 1 mm from the tip of the anatomical papillae, which made it possible to suture the gingival margin upwards towards the cementum-enamel junction.
Subsequently, two slightly divergent oblique beveled incisions were made, starting at the ends of the two horizontal incisions and extending to the alveolar mucosa along 3-4 mm. The resulting flap had partial thickness in the surgical papilla area, full thickness from the gingival margin to 3-4 mm of bone exposure, and partial thickness beyond the mucogingival junction. The flap muscle insertions in the apical zone of bone exposure were eliminated to allow its passive upward movement in the coronal direction.
The root surface was subjected to mechanical treatment with curettes, but only in the area where the clinical junction had been lost, in order to prevent possible damage to the connective tissue fibers that were still anchored in the root cementum. In addition, facial soft tissue deepithelialization was carried out in the anatomical papillae located coronally to the horizontal incisions.
The closure of the flap was performed by a combination of band sutures, applied in the areas of the interdental papillae, and simple sutures, used in the areas of the vertical incisions. Special care was taken to position the soft tissue at the top, in the direction of the cementum-enamel junction, with the aim of counteracting physiological retraction during the healing process.
- Conditions
- Gingival Recession, Localized, Gingival Recession
- Being tested
- Root coverage with tunneling technique
- Keywords
- Root coverage, randomized clinical trial, connective tissue graft, coronally advanced flap
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root coverage with tunneling techniqueProcedure or surgery
Also called Root coverage
THIS IS THE INTERVENTION GROUP THE RECIPIENT AREA OF THE CONNECTIVE GRAFT IS PREPARED.
| Study group | Role | What they receive |
|---|---|---|
| tunneling technique with connective tissue | Experimental | GRUPO TEST: THE RECIPIENT BED OF THE CONNECTIVE GRAFT, THE TUNNELING TECHNIQUE IS PREPARED. Receives: Procedure: Root coverage with tunneling technique |
| coronal advancement flap technique | Experimental | GRUPO CONTROL: THE RECIPIENT BED OF THE CONNECTIVE GRAFT, THE CORONAL ADVANCEMENT FLAP TECHNIQUE IS PREPARED Receives: Procedure: Root coverage with tunneling technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
tunneling technique
Periodontal status and smoking habits (% of bleeding and bacterial plaque) Type ode recesión (I o II) Recession location (upper and lower jaw) Preoperative preparation Treatment in the intervention group Post-surgical treatment Suture time mRC ± SD (%) (recubrimiento radicular) Aesthetic Root Cover Score (RES) percentage of root coverage (RC, %) and percentage of defects with complete root coverage (CRC, %)
Measured: A 3 month follow-up
coronal advancement flap technique
Periodontal status and smoking habits (% of bleeding and bacterial plaque) Type ode recesión (I o II) Recession location (upper and lower jaw) Preoperative preparation Treatment in the control group Post-surgical treatment Suture time Follow-up (months) mRC ± SD (%) (recubrimiento radicular) Aesthetic Root Cover Score (RES) percentage of root coverage (RC, %) and percentage of defects with complete root coverage (CRC, %)
Measured: A 3 month follow-up
tunneling technique
Periodontal status and smoking habits (% of bleeding and bacterial plaque) Type ode recesión (I o II) Recession location (upper and lower jaw) Preoperative preparation Treatment in the intervention group Post-surgical treatment Suture time mRC ± SD (%) (recubrimiento radicular) Aesthetic Root Cover Score (RES) percentage of root coverage (RC, %) and percentage of defects with complete root coverage (CRC, %)
Measured: A 6 month follow-up
coronal advancement flap technique
Periodontal status and smoking habits (% of bleeding and bacterial plaque) Type ode recesión (I o II) Recession location (upper and lower jaw) Preoperative preparation Treatment in the intervention group Post-surgical treatment Suture time mRC ± SD (%) (recubrimiento radicular) Aesthetic Root Cover Score (RES) percentage of root coverage (RC, %) and percentage of defects with complete root coverage (CRC, %)
Measured: A 6 month follow-up
Secondary outcomes (2)
tunneling technique
KERATINIZED TISSUE, RECESSION DEPTH REDUCTION (RECred, mm)
Measured: A 3 - 6 month follow-up
coronal advancement flap technique
KERATINIZED TISSUE, RECESSION DEPTH REDUCTION (RECred, mm)
Measured: A 3 - 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start15 Jan 2024
- Primary completion15 Dec 2024
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, LocalizedStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luis Alberto Chauca Bajaña
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Guayaquil
- Responsible party
- Sponsor-investigator, Luis Alberto Chauca Bajaña, Universidad de Guayaquil
- Investigators
- LUIS CHAUCA, PHD (C), Principal investigator, Universidad de Guayaquil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228534
- Sponsor's protocol ID
- TUN/CAF25/2024
- Status last verified
- Jun 2025
- First submitted
- 18 Jan 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will anonymize and categorize the clinical data of the patients to share the information with the other researchers
Publications
Azaripour A, Kissinger M, Farina VS, Van Noorden CJ, Gerhold-Ay A, Willershausen B, Cortellini P. Root coverage with connective tissue graft associated with coronally advanced flap or tunnel technique: a randomized, double-blind, mono-centre clinical trial. J Clin Periodontol. 2016 Dec;43(12):1142-1150. doi: 10.1111/jcpe.12627. Epub 2016 Oct 25.
PubMed 27716979Tavelli L, Majzoub J, Kauffmann F, Rodriguez MV, Mancini L, Chan HL, Kripfgans OD, Giannobile WV, Wang HL, Barootchi S. Coronally advanced flap versus tunnel technique for the treatment of peri-implant soft tissue dehiscences with the connective tissue graft: A randomized, controlled clinical trial. J Clin Periodontol. 2023 Jul;50(7):980-995. doi: 10.1111/jcpe.13806. Epub 2023 Apr 4.
PubMed 36935199Gonzalez-Febles J, Romandini M, Laciar-Oudshoorn F, Noguerol F, Marruganti C, Bujaldon-Daza A, Zabalegui I, Sanz M. Tunnel vs. coronally advanced flap in combination with a connective tissue graft for the treatment of multiple gingival recessions: a multi-center randomized clinical trial. Clin Oral Investig. 2023 Jul;27(7):3627-3638. doi: 10.1007/s00784-023-04975-7. Epub 2023 Mar 29.
PubMed 36988824Chauca-Bajana L, Vasquez Gonzalez PS, Alban Guijarro MJ, Guim Martinez CA, Velasquez Ron B, Proano Yela P, Lorenzo-Pouso AI, Perez-Jardon A, Ordonez Balladares A. Comparative Effectiveness of Tunneling vs. Coronally Advanced Flap Techniques for Root Coverage: A 6-12-Month Randomized Clinical Trial. Bioengineering (Basel). 2025 Jul 30;12(8):824. doi: 10.3390/bioengineering12080824.
PubMed 40868339
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Root Coverage With Tunneling Technique With Connective Tissue Versus Coronal Advancement Flap Technique. A 3- and 6-month Follow-up of a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06228534
- Acronym / sponsor ID
- TUN/CAF25/2024
- Conditions
- Gingival Recession, Localized, Gingival Recession
- Keywords
- Root coverage, randomized clinical trial, connective tissue graft, coronally advanced flap
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Luis Alberto Chauca BajañaUniversity, hospital or other
- Collaborators
- Universidad de Guayaquil
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 29 Jan 2024 (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 is a randomized triple-blind clinical trial. This comparative clinical study investigates the efficacy of root coverage using two periodontal techniques: the tunneling technique and the coronal advancement technique. The objective is to evaluate and compare the clinical, esthetic and patient perception outcomes after undergoing each procedure. Participants with specific gingival recessions will be included, and follow-up will be performed to measure root coverage, keratinized tissue gain and other relevant parameters. In addition, a detailed analysis of the morbidity associated with each technique will be performed. This study aims to provide valuable information to guide oral health professionals in choosing the most appropriate technique for the treatment of gingival recessions.
Detailed description
Donor area Surgeries were initiated in all participants by removing connective tissue from the mucosa of the palate using the deepithelialized free gingival graft technique.
Receiving area
- TUN + CTG (test group)
Zabalegui et al. detailed the surgical procedure as follows:
The tunnel is created by making a partial-thickness incision in each recession area that will be addressed in the procedure. Special attention is paid to the manipulation of the tissue beyond the mucogingival junction, in order to obtain a tunnel without tension that facilitates the insertion of the graft.
At the level of the interdental papillae, a careful incision is made, raising the papillae gently without separating their tips.
A graft is extracted from the palate that extends from the canine area to the tuberosity, ensuring that it is long enough to cover the root of all the teeth involved.
The graft is inserted into the tunnel using a specific suture technique. The first suture is passed through the most distal part of the recession, and the needle emerges in the most medial part of the recession. The second suture is placed on the opposite side, and the needle emerges in the same medial location of the recession.
The graft, supported by both sutures (mesial and distal), slides smoothly into the tunnel, passing under the interdental papillae. In some cases, specific instruments can help adjust the graft within the tunnel.
Once the graft is in the desired position, both sutures are tied with knots to secure and stabilize the inserted graft. This exposes grafting into the recession area.
CAF + CTG (grupo control) Two beveled incisions were made in a horizontal position, one on the mesial side and one on the distal side of the recession-affected area. These incisions were located at the bases of the papillae and distanced 1 mm from the tip of the anatomical papillae, which made it possible to suture the gingival margin upwards towards the cementum-enamel junction.
Subsequently, two slightly divergent oblique beveled incisions were made, starting at the ends of the two horizontal incisions and extending to the alveolar mucosa along 3-4 mm. The resulting flap had partial thickness in the surgical papilla area, full thickness from the gingival margin to 3-4 mm of bone exposure, and partial thickness beyond the mucogingival junction. The flap muscle insertions in the apical zone of bone exposure were eliminated to allow its passive upward movement in the coronal direction.
The root surface was subjected to mechanical treatment with curettes, but only in the area where the clinical junction had been lost, in order to prevent possible damage to the connective tissue fibers that were still anchored in the root cementum. In addition, facial soft tissue deepithelialization was carried out in the anatomical papillae located coronally to the horizontal incisions.
The closure of the flap was performed by a combination of band sutures, applied in the areas of the interdental papillae, and simple sutures, used in the areas of the vertical incisions. Special care was taken to position the soft tissue at the top, in the direction of the cementum-enamel junction, with the aim of counteracting physiological retraction during the healing process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tunneling technique with connective tissue | Experimental | Procedure: Root coverage with tunneling techniqueGRUPO TEST: THE RECIPIENT BED OF THE CONNECTIVE GRAFT, THE TUNNELING TECHNIQUE IS PREPARED. |
| coronal advancement flap technique | Experimental | Procedure: Root coverage with tunneling techniqueGRUPO CONTROL: THE RECIPIENT BED OF THE CONNECTIVE GRAFT, THE CORONAL ADVANCEMENT FLAP TECHNIQUE IS PREPARED |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Non-smoking
- No systemic diseases, no pregnancy
- No active periodontal disease
- Bacterial plaque and bleeding Score ≤9%.
- No medication that interferes with periodontal tissue health or scarring.
Key exclusion criteria (6 listed)
- SMOKING PATIENT
- PATIENT WITH A SYSTEMIC DISEASE
- WITH PERIODONTAL DISEASE
- GINGIVAL RECESSION CLASS III OR RT3
- PATIENT WITH EDENTULISM
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 |
|---|---|---|
| Root coverage with tunneling techniqueAlso: Root coverageTHIS IS THE INTERVENTION GROUP THE RECIPIENT AREA OF THE CONNECTIVE GRAFT IS PREPARED. | Procedure or surgery | coronal advancement flap technique, tunneling technique with connective tissue |
Primary outcome
tunneling technique
Time frame: A 3 month follow-up
Periodontal status and smoking habits (% of bleeding and bacterial plaque) Type ode recesión (I o II) Recession location (upper and lower jaw) Preoperative preparation Treatment in the intervention group Post-surgical treatment Suture time mRC ± SD (%) (recubrimiento radicular) Aesthetic Root Cover Score (RES) percentage of root coverage (RC, %) and percentage of defects with complete root coverage (CRC, %)
coronal advancement flap technique
Time frame: A 3 month follow-up
Periodontal status and smoking habits (% of bleeding and bacterial plaque) Type ode recesión (I o II) Recession location (upper and lower jaw) Preoperative preparation Treatment in the control group Post-surgical treatment Suture time Follow-up (months) mRC ± SD (%) (recubrimiento radicular) Aesthetic Root Cover Score (RES) percentage of root coverage (RC, %) and percentage of defects with complete root coverage (CRC, %)
tunneling technique
Time frame: A 6 month follow-up
Periodontal status and smoking habits (% of bleeding and bacterial plaque) Type ode recesión (I o II) Recession location (upper and lower jaw) Preoperative preparation Treatment in the intervention group Post-surgical treatment Suture time mRC ± SD (%) (recubrimiento radicular) Aesthetic Root Cover Score (RES) percentage of root coverage (RC, %) and percentage of defects with complete root coverage (CRC, %)
coronal advancement flap technique
Time frame: A 6 month follow-up
Periodontal status and smoking habits (% of bleeding and bacterial plaque) Type ode recesión (I o II) Recession location (upper and lower jaw) Preoperative preparation Treatment in the intervention group Post-surgical treatment Suture time mRC ± SD (%) (recubrimiento radicular) Aesthetic Root Cover Score (RES) percentage of root coverage (RC, %) and percentage of defects with complete root coverage (CRC, %)
2 secondary outcomes
tunneling technique
Time frame: A 3 - 6 month follow-up
coronal advancement flap technique
Time frame: A 3 - 6 month follow-up
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 2 Jul 2025.
- Results publication: PubMed 27716979Azaripour A, Kissinger M, Farina VS, Van Noorden CJ, Gerhold-Ay A, Willershausen B, Cortellini P. Root coverage with connective tissue graft associated with coronally advanced flap or tunnel technique: a randomized, double-blind, mono-centre clinical trial. J Clin Periodontol. 2016 Dec;43(12):1142-1150. doi: 10.1111/jcpe.12627. Epub 2016 Oct 25.
- Results publication: PubMed 36935199Tavelli L, Majzoub J, Kauffmann F, Rodriguez MV, Mancini L, Chan HL, Kripfgans OD, Giannobile WV, Wang HL, Barootchi S. Coronally advanced flap versus tunnel technique for the treatment of peri-implant soft tissue dehiscences with the connective tissue graft: A randomized, controlled clinical trial. J Clin Periodontol. 2023 Jul;50(7):980-995. doi: 10.1111/jcpe.13806. Epub 2023 Apr 4.
- Results publication: PubMed 36988824Gonzalez-Febles J, Romandini M, Laciar-Oudshoorn F, Noguerol F, Marruganti C, Bujaldon-Daza A, Zabalegui I, Sanz M. Tunnel vs. coronally advanced flap in combination with a connective tissue graft for the treatment of multiple gingival recessions: a multi-center randomized clinical trial. Clin Oral Investig. 2023 Jul;27(7):3627-3638. doi: 10.1007/s00784-023-04975-7. Epub 2023 Mar 29.
- Derived from this study: PubMed 40868339Chauca-Bajana L, Vasquez Gonzalez PS, Alban Guijarro MJ, Guim Martinez CA, Velasquez Ron B, Proano Yela P, Lorenzo-Pouso AI, Perez-Jardon A, Ordonez Balladares A. Comparative Effectiveness of Tunneling vs. Coronally Advanced Flap Techniques for Root Coverage: A 6-12-Month Randomized Clinical Trial. Bioengineering (Basel). 2025 Jul 30;12(8):824. doi: 10.3390/bioengineering12080824.
- Individual participant dataSharing planned: Yes. We will anonymize and categorize the clinical data of the patients to share the information with the other researchers
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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.
LUIS CHAUCA, PHD (C) principal investigator
Universidad de Guayaquil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Root coverage with tunneling technique in people with Gingival Recession, Localized and Gingival Recession, run by Luis Alberto Chauca Bajaña at 1 site in Ecuador.
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 10 inclusion and 6 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 2 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 Ecuador. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
tunneling technique (time frame: A 3 month follow-up). The study lists 4 primary outcomes in all. 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 NCT06228534, which also lists 4 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 2 Jul 2025.