Gingival RecessionNCT04225351
Treatment of Multiple Gingival Recessions With a MCAF or a MCAT and a Collagen Matrix
A study testing MCAF+CM and MCAT+CM in people with Gingival Recession, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
In a recent meta-analysis, Graziani et al. reported that despite the "ideal" treatment for multiple gingival recession defects is not yet identified, there are some indirect suggestions from the analyzed data that, in comparison to the traditional coronally advanced flap (CAF) approach, the use of additional grafting… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- MCAF+CM and MCAT+CM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 12 May 2019to Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- multiple (i.e., at least 2) Miller Class I and/or II gingival recessions located in the maxillary, with an apico-coronal extension (i.e., defect depth > 1 mm with at least one defect > 2 mm) and with at least 1 mm of residual keratinized tissue,
- good general health, with no systemic diseases that could influence the outcome of the therapy,
- healthy periodontal conditions (i.e., no presence of sites ≥ 4 mm and/or presence of intra-bony defects in the selected sites),
- adequate oral hygiene (full mouth plaque score (FMPS) of <25% at baseline (following initial oral hygiene instructions and prophylaxis),
- an adequate control of inflammation (full mouth bleeding score [FMBS]) of <25% at baseline (following initial oral hygiene instructions and prophylaxis).
Who cannot join
- subjects who currently smoke >10 cigarettes/day,
- female subjects who are nursing, pregnant, or plan to become pregnant,
- contraindication against oral surgical interventions,
- contraindication against use of Fibro-Gide (acute infection in the area of surgery and patient with collagen allergy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Multiple Gingival Recession Defects With a Coronally Advanced Flap or a Modified Tunnel Technique and a Volume Stable Three-dimensional Xenogeneic Collagen Matrix: a Monocentric Randomized Clinical Trial
In a recent meta-analysis, Graziani et al. reported that despite the "ideal" treatment for multiple gingival recession defects is not yet identified, there are some indirect suggestions from the analyzed data that, in comparison to the traditional coronally advanced flap (CAF) approach, the use of additional grafting, modifications of the flap technique or tunnel variation with connective tissue graft (CTG) may improve clinical results.
Furthermore, various allografts or replacement biomaterials have been developed instead of a connective tissue graft in order to reduce patient morbidity. A newly developed porcine-derived bio-resorbable collagen matrix (CM) (Fibro-Gide) has been recently introduced as an alternative to CTG in periodontal plastic surgery.
Read more
The aim of this study will be to compare the outcomes of two muco-gingival surgery techniques, the modified coronali advanced flap (MCAF) for multiple recession defects and the modified coronally advanced tunnel technique (MCAT), performed in the Department of Periodontology of San Raffaele Hospital with the results reported in the literature.
Secondarily, the study will evaluate whether patients report a preference in terms of discomfort and perception of aesthetics between the two surgical techniques.
Read the detailed description
The present research is a monocentric prospective parallel randomized controlled clinical trial.
Patients presenting multiple gingival recessions in the maxillary will be enrolled in the study after having signed an informed consent. Recessions will be treated by means of two mucogingival surgery techniques: modified coronally advanced flap (MCAF) and modified coronally advanced tunnel technique (MCAT), in association with the use of a collagen matrix (CM).
Two experienced practitioners (M.d.S. and S.A.) will perform the surgical session according to the technique as presented by Zucchelli \& de Sanctis 2000 and Aroca et al. 2013.
- Modified coronally advanced flap (MCAF): After local anesthesia, a horizontal incision is made to include one tooth on each side of the teeth to be treated. The horizontal incision of the envelope flap consists of oblique sub-marginal incisions in the interdental areas, incisions which continue with the intra-sulcular incision at the recession defects.
Each surgical papilla (SP) is dislocated with respect to the anatomic papilla by the oblique sub-marginal interdental incisions; in particular, the surgical papilla mesial to the flap midline are dislocated more apically and distally, while the papilla distal to the mid-line are shifted in a more apical and mesial position.
The envelope flap is raised with a split-full-split approach in the coronal-apical direction: the surgical papilla is dissected in a split-thickness manner, while gingival tissue apical to the root exposures is raised in a full-thickness manner (to provide that portion of the flap critical for root coverage with more thickness). Finally, the most apical portion of the flap is elevated in a split-thickness manner to facilitate the coronal displacement of the flap.
The portion of the root exposure with loss of clinical attachment (gingival recession plus probeable gingival sulcus/pocket) are mechanically treated with the use of curettes and EDTA is applied for 2 minutes.
The remaining tissue of the anatomic interdental papilla is de-epithelialized to create connective tissue beds to which the surgical papilla are sutured.
A sharp dissection into the vestibular lining mucosa is then carried out to eliminate muscle tension. Flap mobilization is considered "adequate" when the marginal portion of the flap is able to passively reach a level coronal to the cemento-enamel junction (CEJ) at each single tooth in the surgical site. The flap, in fact, should be stable in its final position even without the sutures.
The porcine-derived bio-resorbable collagen matrix (CM) (Fibro-Gide) is now prepared for placement on the interested areas: the width of the matrix must be reduced to 3-4 mm and the matrix has to adapt to the receiving tissues, when placed, a suture (6/00) must be used to hold it in position.
Sling sutures (6/00) are performed to accomplish a precise adaptation of the buccal flap on the exposed root surfaces and to stabilize every single surgical papilla over the interdental connective tissue bed.
- Modified coronally advanced tunnel technique (MCAT): Immediately before surgery, composite stops are placed at the contact points to prevent collapse of the future suspended sutures into the inter-proximal spaces.
After local anaesthesia, root planing of the exposed root surface is performed by means of hand instruments. Ethylenediaminetetraacetic (EDTA) is applied on the sites.
Subsequently, intra-sulcular incisions were placed and muco-periosteal flap separation are raised using sharp tunnel elevators. The muco-periosteal dissection is extended beyond the muco-gingival junction (MGJ) and under each papilla, to allow passive, tension-free mobilization in coronal direction. Muscle fibres and any remaining collagen bundles on the inner aspect of the flap alveolar mucosa are cut using Gracey curettes with extreme care in order to obtain a passive coronal positioning of the flap and the papilla and to avoid perforation of the flap.
The porcine-derived bio-resorbable collagen matrix (Fibro-Gide) is now prepared for placement on the interested areas: the width of the matrix must be reduced to 3-4 mm, then it can be inserted under the MCAT by starting at the deepest recession. Then, the matrix is retracted laterally towards each end of the tunnel by means of mattress sutures. After positioning the matrix laterally, the site is rinsed with saline solution to remove any clot. The matrix has to be held in position using a suture (6/00).
Finally, the flap is positioned coronally to CEJ by means of suspended sutures (6/00) around the contact points.
At surgery, the duration of the full procedure will be evaluated (from anesthesia to suture).
All patients will be recall after 1, 2 and 4 weeks. They will be further recalled 3, 6 and 12 months after surgery for professional oral hygiene procedures and measurements.
- Conditions
- Gingival Recession
- Being tested
- MCAF+CM, MCAT+CM
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCAF+CMProcedure or surgery
CAF procedure + collagen matrix
MCAT+CMProcedure or surgery
Tunnel procedure + collagen matrix
| Study group | Role | What they receive |
|---|---|---|
| MCAF+CM | Experimental | Modified coronally advanced flap + collagen matrix Receives: Procedure: MCAF+CM |
| MCAT+CM | Active comparator | Modified coronally advanced tunnel technique + collagen matrix Receives: Procedure: MCAT+CM |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage (%) of complete root coverage (CRC)
Ratio scale - higher values represent a better result
Measured: 12 months
Secondary outcomes (4)
keratinized tissue width (KTW)
Ratio scale - higher values represent a better result
Measured: 3, 6 and 12 months
gingival thickness (GT)
Ratio scale - higher values represent a better result
Measured: 3, 6 and 12 months
percentage of root coverage (RC %)
Ratio scale - higher values represent a better result
Measured: 3, 6 and 12 months
post-surgical pain (PP),
Visual analog scale (VAS) - values from 0=[no pain] to 10=[worst pain ever]
Measured: 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start12 May 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo de Sanctis, Università Vita-Salute San Raffaele
- Investigators
- Massimo de Sanctis, MD, Principal investigator, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225351
- Sponsor's protocol ID
- Fibro-gide 1
- Status last verified
- Mar 2024
- First submitted
- 8 Jan 2020
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aroca S, Molnar B, Windisch P, Gera I, Salvi GE, Nikolidakis D, Sculean A. Treatment of multiple adjacent Miller class I and II gingival recessions with a Modified Coronally Advanced Tunnel (MCAT) technique and a collagen matrix or palatal connective tissue graft: a randomized, controlled clinical trial. J Clin Periodontol. 2013 Jul;40(7):713-20. doi: 10.1111/jcpe.12112. Epub 2013 Apr 30.
PubMed 23627374Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Coronally advanced flap with and without vertical releasing incisions for the treatment of multiple gingival recessions: a comparative controlled randomized clinical trial. J Periodontol. 2009 Jul;80(7):1083-94. doi: 10.1902/jop.2009.090041.
PubMed 19563288Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10.
PubMed 23050490Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009 Feb;80(2):244-52. doi: 10.1902/jop.2009.080253.
PubMed 19186964Thombre V, Koudale SB, Bhongade ML. Comparative evaluation of the effectiveness of coronally positioned flap with or without acellular dermal matrix allograft in the treatment of multiple marginal gingival recession defects. Int J Periodontics Restorative Dent. 2013 May-Jun;33(3):e88-94. doi: 10.11607/prd.1371.
PubMed 23593633
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Multiple Gingival Recession Defects With a Coronally Advanced Flap or a Modified Tunnel Technique and a Volume Stable Three-dimensional Xenogeneic Collagen Matrix: a Monocentric Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04225351
- Acronym / sponsor ID
- Fibro-gide 1
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- 12 May 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Jan 2020 (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.
In a recent meta-analysis, Graziani et al. reported that despite the "ideal" treatment for multiple gingival recession defects is not yet identified, there are some indirect suggestions from the analyzed data that, in comparison to the traditional coronally advanced flap (CAF) approach, the use of additional grafting, modifications of the flap technique or tunnel variation with connective tissue graft (CTG) may improve clinical results.
Furthermore, various allografts or replacement biomaterials have been developed instead of a connective tissue graft in order to reduce patient morbidity. A newly developed porcine-derived bio-resorbable collagen matrix (CM) (Fibro-Gide) has been recently introduced as an alternative to CTG in periodontal plastic surgery.
The aim of this study will be to compare the outcomes of two muco-gingival surgery techniques, the modified coronali advanced flap (MCAF) for multiple recession defects and the modified coronally advanced tunnel technique (MCAT), performed in the Department of Periodontology of San Raffaele Hospital with the results reported in the literature.
Secondarily, the study will evaluate whether patients report a preference in terms of discomfort and perception of aesthetics between the two surgical techniques.
Detailed description
The present research is a monocentric prospective parallel randomized controlled clinical trial.
Patients presenting multiple gingival recessions in the maxillary will be enrolled in the study after having signed an informed consent. Recessions will be treated by means of two mucogingival surgery techniques: modified coronally advanced flap (MCAF) and modified coronally advanced tunnel technique (MCAT), in association with the use of a collagen matrix (CM).
Two experienced practitioners (M.d.S. and S.A.) will perform the surgical session according to the technique as presented by Zucchelli \& de Sanctis 2000 and Aroca et al. 2013.
- Modified coronally advanced flap (MCAF): After local anesthesia, a horizontal incision is made to include one tooth on each side of the teeth to be treated. The horizontal incision of the envelope flap consists of oblique sub-marginal incisions in the interdental areas, incisions which continue with the intra-sulcular incision at the recession defects.
Each surgical papilla (SP) is dislocated with respect to the anatomic papilla by the oblique sub-marginal interdental incisions; in particular, the surgical papilla mesial to the flap midline are dislocated more apically and distally, while the papilla distal to the mid-line are shifted in a more apical and mesial position.
The envelope flap is raised with a split-full-split approach in the coronal-apical direction: the surgical papilla is dissected in a split-thickness manner, while gingival tissue apical to the root exposures is raised in a full-thickness manner (to provide that portion of the flap critical for root coverage with more thickness). Finally, the most apical portion of the flap is elevated in a split-thickness manner to facilitate the coronal displacement of the flap.
The portion of the root exposure with loss of clinical attachment (gingival recession plus probeable gingival sulcus/pocket) are mechanically treated with the use of curettes and EDTA is applied for 2 minutes.
The remaining tissue of the anatomic interdental papilla is de-epithelialized to create connective tissue beds to which the surgical papilla are sutured.
A sharp dissection into the vestibular lining mucosa is then carried out to eliminate muscle tension. Flap mobilization is considered "adequate" when the marginal portion of the flap is able to passively reach a level coronal to the cemento-enamel junction (CEJ) at each single tooth in the surgical site. The flap, in fact, should be stable in its final position even without the sutures.
The porcine-derived bio-resorbable collagen matrix (CM) (Fibro-Gide) is now prepared for placement on the interested areas: the width of the matrix must be reduced to 3-4 mm and the matrix has to adapt to the receiving tissues, when placed, a suture (6/00) must be used to hold it in position.
Sling sutures (6/00) are performed to accomplish a precise adaptation of the buccal flap on the exposed root surfaces and to stabilize every single surgical papilla over the interdental connective tissue bed.
- Modified coronally advanced tunnel technique (MCAT): Immediately before surgery, composite stops are placed at the contact points to prevent collapse of the future suspended sutures into the inter-proximal spaces.
After local anaesthesia, root planing of the exposed root surface is performed by means of hand instruments. Ethylenediaminetetraacetic (EDTA) is applied on the sites.
Subsequently, intra-sulcular incisions were placed and muco-periosteal flap separation are raised using sharp tunnel elevators. The muco-periosteal dissection is extended beyond the muco-gingival junction (MGJ) and under each papilla, to allow passive, tension-free mobilization in coronal direction. Muscle fibres and any remaining collagen bundles on the inner aspect of the flap alveolar mucosa are cut using Gracey curettes with extreme care in order to obtain a passive coronal positioning of the flap and the papilla and to avoid perforation of the flap.
The porcine-derived bio-resorbable collagen matrix (Fibro-Gide) is now prepared for placement on the interested areas: the width of the matrix must be reduced to 3-4 mm, then it can be inserted under the MCAT by starting at the deepest recession. Then, the matrix is retracted laterally towards each end of the tunnel by means of mattress sutures. After positioning the matrix laterally, the site is rinsed with saline solution to remove any clot. The matrix has to be held in position using a suture (6/00).
Finally, the flap is positioned coronally to CEJ by means of suspended sutures (6/00) around the contact points.
At surgery, the duration of the full procedure will be evaluated (from anesthesia to suture).
All patients will be recall after 1, 2 and 4 weeks. They will be further recalled 3, 6 and 12 months after surgery for professional oral hygiene procedures and measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCAF+CM | Experimental | Procedure: MCAF+CMModified coronally advanced flap + collagen matrix |
| MCAT+CM | Active comparator | Procedure: MCAT+CMModified coronally advanced tunnel technique + collagen matrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- multiple (i.e., at least 2) Miller Class I and/or II gingival recessions located in the maxillary, with an apico-coronal extension (i.e., defect depth > 1 mm with at least one defect > 2 mm) and with at least 1 mm of residual keratinized tissue,
- good general health, with no systemic diseases that could influence the outcome of the therapy,
- healthy periodontal conditions (i.e., no presence of sites ≥ 4 mm and/or presence of intra-bony defects in the selected sites),
- adequate oral hygiene (full mouth plaque score (FMPS) of <25% at baseline (following initial oral hygiene instructions and prophylaxis),
- an adequate control of inflammation (full mouth bleeding score [FMBS]) of <25% at baseline (following initial oral hygiene instructions and prophylaxis).
Key exclusion criteria (4 listed)
- subjects who currently smoke >10 cigarettes/day,
- female subjects who are nursing, pregnant, or plan to become pregnant,
- contraindication against oral surgical interventions,
- contraindication against use of Fibro-Gide (acute infection in the area of surgery and patient with collagen allergy)
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 |
|---|---|---|
| MCAF+CMCAF procedure + collagen matrix | Procedure or surgery | MCAF+CM |
| MCAT+CMTunnel procedure + collagen matrix | Procedure or surgery | MCAT+CM |
Primary outcome
percentage (%) of complete root coverage (CRC)
Time frame: 12 months
Ratio scale - higher values represent a better result
4 secondary outcomes
keratinized tissue width (KTW)
Time frame: 3, 6 and 12 months
gingival thickness (GT)
Time frame: 3, 6 and 12 months
percentage of root coverage (RC %)
Time frame: 3, 6 and 12 months
post-surgical pain (PP),
Time frame: 1 week after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Background: PubMed 23627374Aroca S, Molnar B, Windisch P, Gera I, Salvi GE, Nikolidakis D, Sculean A. Treatment of multiple adjacent Miller class I and II gingival recessions with a Modified Coronally Advanced Tunnel (MCAT) technique and a collagen matrix or palatal connective tissue graft: a randomized, controlled clinical trial. J Clin Periodontol. 2013 Jul;40(7):713-20. doi: 10.1111/jcpe.12112. Epub 2013 Apr 30.
- Background: PubMed 19563288Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Coronally advanced flap with and without vertical releasing incisions for the treatment of multiple gingival recessions: a comparative controlled randomized clinical trial. J Periodontol. 2009 Jul;80(7):1083-94. doi: 10.1902/jop.2009.090041.
- Background: PubMed 23050490Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10.
- Background: PubMed 19186964Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009 Feb;80(2):244-52. doi: 10.1902/jop.2009.080253.
- Background: PubMed 23593633Thombre V, Koudale SB, Bhongade ML. Comparative evaluation of the effectiveness of coronally positioned flap with or without acellular dermal matrix allograft in the treatment of multiple marginal gingival recession defects. Int J Periodontics Restorative Dent. 2013 May-Jun;33(3):e88-94. doi: 10.11607/prd.1371.
- 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.
Massimo de Sanctis, MD principal investigator
Università Vita-Salute San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCAF+CM and MCAT+CM in people with Gingival Recession, run by Università Vita-Salute San Raffaele at 1 site in Italy.
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 4 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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. 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 Italy. 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?
Results are not available in the source record.
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?
percentage (%) of complete root coverage (CRC) (time frame: 12 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 NCT04225351, which also lists 5 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 7 Mar 2024.