Gingival RecessionNCT03791554
Laterally Closed Tunnel VS Tunneling Technique in Recession Type 2
A study testing Group A (Lateral closed tunnel subepithelial CT graft) and Group B (Tunnel procedure with subepithelial CT graft) in people with Gingival Recession, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to assess the effect of tunneling technique with subepithelial connective tissue graft versus tunneling technique with laterally closed tunnel in treatment of recession type 2 defect.Few randomized clinical trial has been involved with recession type 2 defects treated with tunneling technique and… 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?
- Group A (Lateral closed tunnel subepithelial CT graft) and Group B (Tunnel procedure with subepithelial CT graft)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 1 Sep 2021
- 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
- Patients 18 years or older.
- Patients with healthy systemic condition
- Buccal recession defects with recession type 2 defects.
- Clinical indication and/or patient request for recession coverage.
- O'Leary index less than 20%
Who cannot join
- Pregnant females.
- Smokers as it is a contraindication for any plastic periodontal surgery
- Unmotivated, uncooperative patients with poor oral hygiene
- Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of Laterally Closed Tunnel With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Subepithelial Connective Tissue Graft in Isolated Recession Type 2; Randomized Clinical Trial
This study aims to assess the effect of tunneling technique with subepithelial connective tissue graft versus tunneling technique with laterally closed tunnel in treatment of recession type 2 defect.Few randomized clinical trial has been involved with recession type 2 defects treated with tunneling technique and coronal advanced flap.
Read the detailed description
Tunneling with subepithelial connective tissue graft:
At the recipient site (recession defect):
After scaling and root planning. A sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact.
At donor site (palate):
A connective tissue graft is harvested from the palate after administration of local anesthesia using a partial thickness flap which will be raised with single incision.
Then the graft is placed and secured in the recipient site using suture. The flap is displaced to be in a coronal position using a suture.
Tunneling technique with the laterally closed tunnel):
After local anesthesia, root planing of the exposed root surface will be performed. An intrasulcular incisions will be made creating a tunnel extending to the mucogingival line and mesial and distal recession defects while keeping the interdental papilla intact as well as not perforating the flap.
- Donor SCTG Subsequently, a palatal SCTG will be harvested by means of the single incision technique with immediate closure of the donor site.
- Recipient site; Using either single or mattress sutures, the SCTG will be pulled and fixed mesially and distally at the inner aspect of the pouch. The graft will be adapted to the CEJ by means of a sling suture. Finally, the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface.
- Conditions
- Gingival Recession
- Being tested
- Group A (Lateral closed tunnel subepithelial CT graft), Group B (Tunnel procedure with subepithelial CT graft)
- Keywords
- tunneling, laterally closed tunnel, gingival recession, recession type 2
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (Lateral closed tunnel subepithelial CT graft)Procedure or surgery
Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the adjacent teeth to treating gingival recession with edges of the recession sutured together after placing connective tissue graft
Group B (Tunnel procedure with subepithelial CT graft)Procedure or surgery
Also called Autogenous sCTG will be used with tunnel procedure
Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the prepared tunnel to treating gingival recession
| Study group | Role | What they receive |
|---|---|---|
| Group A : Lateral closed Tunnel | Active comparator | Laterally closed tunnel procedure with subepithelial connective tissue graft (sCTG) After local anesthesia, root planing will be performed. Recession defect - a tunneling technique will be prepared using sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact.
• Recipient site; Using either single or mattress sutures, the graft will be pulled and fixed mesially and distally at the inner aspect of the pouch. The graft will be adapted to the CEJ by means of a sling suture. Margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface. Receives: Procedure: Group A (Lateral closed tunnel subepithelial CT graft) |
| Group B : Tunneling | Active comparator | Tunnel procedure with subepithelial connective tissue graft (sCTG) - Control:
At the recipient site (recession defect): a tunneling technique will be prepared using sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact.
Then the graft is placed and secured in the recipient site. The flap is displaced to be in a coronal position using a sling suture with no suturing to approximate the margins together. Receives: Procedure: Group B (Tunnel procedure with subepithelial CT graft) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction Recession Depth
recession depth measured from CEJ to the gingival margin in a cross-section at the central buccal site.
Measured: 6 month
Secondary outcomes (10)
Gingival recession depth.
Measured as the distance between the gingival margin and the mucogingival junction
Measured: 6 month
Gingival recession width
Measured as the distance between the gingival margin adjacent to the defect
Measured: 6 month
Root coverage esthetic score (RES)
system used to evaluated five variables 6 months gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC).
Measured: 6 month
Probing depth
Measured from the gingival margin to the bottom of the gingival sulcus
Measured: 6 month
Clinical attachment level
Measured from the CEJ to the bottom of the gingival sulcus.
Measured: 6 month
Width of keratinized tissue
Measured as the distance between the gingival margin and the mucogingival junction
Measured: 6 month
Gingival thickness
The measurement of Gingival tissue thickness is performed 2 mm apical from the gingival margin.
Measured: 6 month
Post-operative pain
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst' pain imaginable)
Measured: 2 weeks
Post-Surgical Patient Satisfaction Questionnaire
A 3-item questionnaire is asked and the patients shall use a 7-point answer scale. The answers were given on a 7-point scale ranging from 1 ''not at all'' to 7 ''very likely''
Measured: 6 month
Percentage complete root coverage
(Preoperative vertical recession -- Postoperative vertical recession/preoperative vertical recession) x 100
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start1 Aug 2020
- Primary completion16 Mar 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Its a randomised clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yahya Hassan El Banna Amer, Cairo University
- Investigators
- Manal Hosny, PhD, Study chair, Cairo UniversityHani El-Nahass, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791554
- Sponsor's protocol ID
- Perio2414
- Status last verified
- Nov 2023
- First submitted
- 15 Dec 2018
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I will check with my Study Chair
Publications
Agudio G, Nieri M, Rotundo R, Cortellini P, Pini Prato G. Free gingival grafts to increase keratinized tissue: a retrospective long-term evaluation (10 to 25 years) of outcomes. J Periodontol. 2008 Apr;79(4):587-94. doi: 10.1902/jop.2008.070414.
PubMed 18380550Aroca S, Keglevich T, Nikolidakis D, Gera I, Nagy K, Azzi R, Etienne D. Treatment of class III multiple gingival recessions: a randomized-clinical trial. J Clin Periodontol. 2010 Jan;37(1):88-97. doi: 10.1111/j.1600-051X.2009.01492.x. Epub 2009 Nov 30.
PubMed 19968743Baldi C, Pini-Prato G, Pagliaro U, Nieri M, Saletta D, Muzzi L, Cortellini P. Coronally advanced flap procedure for root coverage. Is flap thickness a relevant predictor to achieve root coverage? A 19-case series. J Periodontol. 1999 Sep;70(9):1077-84. doi: 10.1902/jop.1999.70.9.1077.
PubMed 10505811Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.
PubMed 21507033Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.
PubMed 19335093Cortellini P, Tonetti M, Baldi C, Francetti L, Rasperini G, Rotundo R, Nieri M, Franceschi D, Labriola A, Prato GP. Does placement of a connective tissue graft improve the outcomes of coronally advanced flap for coverage of single gingival recessions in upper anterior teeth? A multi-centre, randomized, double-blind, clinical trial. J Clin Periodontol. 2009 Jan;36(1):68-79. doi: 10.1111/j.1600-051X.2008.01346.x. Epub 2008 Nov 20.
PubMed 19046326Dominiak M, Gedrange T. New perspectives in the diagnostic of gingival recession. Adv Clin Exp Med. 2014 Nov-Dec;23(6):857-63. doi: 10.17219/acem/27907.
PubMed 25618109Edel A. Clinical evaluation of free connective tissue grafts used to increase the width of keratinised gingiva. 1974. Periodontal Clin Investig. 1998 Spring;20(1):12-20. No abstract available.
PubMed 9663118Esteibar JR, Zorzano LA, Cundin EE, Blanco JD, Medina JR. Complete root coverage of Miller Class III recessions. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):e1-7.
PubMed 21837295Kassab MM, Cohen RE. The etiology and prevalence of gingival recession. J Am Dent Assoc. 2003 Feb;134(2):220-5. doi: 10.14219/jada.archive.2003.0137.
PubMed 12636127Khuller N. Coverage of gingival recession using tunnel connective tissue graft technique. J Indian Soc Periodontol. 2009 May;13(2):101-5. doi: 10.4103/0972-124X.55838.
PubMed 20407659Langer B, Langer L. Subepithelial connective tissue graft technique for root coverage. J Periodontol. 1985 Dec;56(12):715-20. doi: 10.1902/jop.1985.56.12.715.
PubMed 3866056Miller PD Jr. A classification of marginal tissue recession. Int J Periodontics Restorative Dent. 1985;5(2):8-13. No abstract available.
PubMed 3858267Nordland WP, Tarnow DP. A classification system for loss of papillary height. J Periodontol. 1998 Oct;69(10):1124-6. doi: 10.1902/jop.1998.69.10.1124.
PubMed 9802711Raetzke PB. Covering localized areas of root exposure employing the "envelope" technique. J Periodontol. 1985 Jul;56(7):397-402. doi: 10.1902/jop.1985.56.7.397.
PubMed 3894614
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Laterally Closed Tunnel With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Subepithelial Connective Tissue Graft in Isolated Recession Type 2; Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03791554
- Acronym / sponsor ID
- Perio2414
- Conditions
- Gingival Recession
- Keywords
- tunneling, laterally closed tunnel, gingival recession, recession type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 2 Jan 2019 (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 study aims to assess the effect of tunneling technique with subepithelial connective tissue graft versus tunneling technique with laterally closed tunnel in treatment of recession type 2 defect.Few randomized clinical trial has been involved with recession type 2 defects treated with tunneling technique and coronal advanced flap.
Detailed description
Tunneling with subepithelial connective tissue graft:
At the recipient site (recession defect):
After scaling and root planning. A sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact.
At donor site (palate):
A connective tissue graft is harvested from the palate after administration of local anesthesia using a partial thickness flap which will be raised with single incision.
Then the graft is placed and secured in the recipient site using suture. The flap is displaced to be in a coronal position using a suture.
Tunneling technique with the laterally closed tunnel):
After local anesthesia, root planing of the exposed root surface will be performed. An intrasulcular incisions will be made creating a tunnel extending to the mucogingival line and mesial and distal recession defects while keeping the interdental papilla intact as well as not perforating the flap.
- Donor SCTG Subsequently, a palatal SCTG will be harvested by means of the single incision technique with immediate closure of the donor site.
- Recipient site; Using either single or mattress sutures, the SCTG will be pulled and fixed mesially and distally at the inner aspect of the pouch. The graft will be adapted to the CEJ by means of a sling suture. Finally, the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Its a randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group A : Lateral closed Tunnel | Active comparator | Procedure: Group A (Lateral closed tunnel subepithelial CT graft)Laterally closed tunnel procedure with subepithelial connective tissue graft (sCTG) After local anesthesia, root planing will be performed. Recession defect - a tunneling technique will be prepared using sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact. • Recipient site; Using either single or mattress sutures, the graft will be pulled and fixed mesially and distally at the inner aspect of the pouch. The graft will be adapted to the CEJ by means of a sling suture. Margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface. |
| Group B : Tunneling | Active comparator | Procedure: Group B (Tunnel procedure with subepithelial CT graft)Tunnel procedure with subepithelial connective tissue graft (sCTG) - Control: At the recipient site (recession defect): a tunneling technique will be prepared using sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact. Then the graft is placed and secured in the recipient site. The flap is displaced to be in a coronal position using a sling suture with no suturing to approximate the margins together. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 18 years or older.
- Patients with healthy systemic condition
- Buccal recession defects with recession type 2 defects.
- Clinical indication and/or patient request for recession coverage.
- O'Leary index less than 20%
Key exclusion criteria (4 listed)
- Pregnant females.
- Smokers as it is a contraindication for any plastic periodontal surgery
- Unmotivated, uncooperative patients with poor oral hygiene
- Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.
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 |
|---|---|---|
| Group A (Lateral closed tunnel subepithelial CT graft)Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the adjacent teeth to treating gingival recession with edges of the recession sutured together after placing connective tissue graft | Procedure or surgery | Group A : Lateral closed Tunnel |
| Group B (Tunnel procedure with subepithelial CT graft)Also: Autogenous sCTG will be used with tunnel procedureSubepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the prepared tunnel to treating gingival recession | Procedure or surgery | Group B : Tunneling |
Primary outcome
Reduction Recession Depth
Time frame: 6 month
recession depth measured from CEJ to the gingival margin in a cross-section at the central buccal site.
10 secondary outcomes
Gingival recession depth.
Time frame: 6 month
Gingival recession width
Time frame: 6 month
Root coverage esthetic score (RES)
Time frame: 6 month
Probing depth
Time frame: 6 month
Clinical attachment level
Time frame: 6 month
Width of keratinized tissue
Time frame: 6 month
Gingival thickness
Time frame: 6 month
Post-operative pain
Time frame: 2 weeks
Post-Surgical Patient Satisfaction Questionnaire
Time frame: 6 month
Percentage complete root coverage
Time frame: 6 month
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 6 Dec 2023.
- Background: PubMed 18380550Agudio G, Nieri M, Rotundo R, Cortellini P, Pini Prato G. Free gingival grafts to increase keratinized tissue: a retrospective long-term evaluation (10 to 25 years) of outcomes. J Periodontol. 2008 Apr;79(4):587-94. doi: 10.1902/jop.2008.070414.
- Background: PubMed 19968743Aroca S, Keglevich T, Nikolidakis D, Gera I, Nagy K, Azzi R, Etienne D. Treatment of class III multiple gingival recessions: a randomized-clinical trial. J Clin Periodontol. 2010 Jan;37(1):88-97. doi: 10.1111/j.1600-051X.2009.01492.x. Epub 2009 Nov 30.
- Background: PubMed 10505811Baldi C, Pini-Prato G, Pagliaro U, Nieri M, Saletta D, Muzzi L, Cortellini P. Coronally advanced flap procedure for root coverage. Is flap thickness a relevant predictor to achieve root coverage? A 19-case series. J Periodontol. 1999 Sep;70(9):1077-84. doi: 10.1902/jop.1999.70.9.1077.
- Background: PubMed 21507033Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.
- Background: PubMed 19335093Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.
- Background: PubMed 19046326Cortellini P, Tonetti M, Baldi C, Francetti L, Rasperini G, Rotundo R, Nieri M, Franceschi D, Labriola A, Prato GP. Does placement of a connective tissue graft improve the outcomes of coronally advanced flap for coverage of single gingival recessions in upper anterior teeth? A multi-centre, randomized, double-blind, clinical trial. J Clin Periodontol. 2009 Jan;36(1):68-79. doi: 10.1111/j.1600-051X.2008.01346.x. Epub 2008 Nov 20.
- Background: PubMed 25618109Dominiak M, Gedrange T. New perspectives in the diagnostic of gingival recession. Adv Clin Exp Med. 2014 Nov-Dec;23(6):857-63. doi: 10.17219/acem/27907.
- Background: PubMed 9663118Edel A. Clinical evaluation of free connective tissue grafts used to increase the width of keratinised gingiva. 1974. Periodontal Clin Investig. 1998 Spring;20(1):12-20. No abstract available.
- Background: PubMed 21837295Esteibar JR, Zorzano LA, Cundin EE, Blanco JD, Medina JR. Complete root coverage of Miller Class III recessions. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):e1-7.
- Background: PubMed 12636127Kassab MM, Cohen RE. The etiology and prevalence of gingival recession. J Am Dent Assoc. 2003 Feb;134(2):220-5. doi: 10.14219/jada.archive.2003.0137.
- Background: PubMed 20407659Khuller N. Coverage of gingival recession using tunnel connective tissue graft technique. J Indian Soc Periodontol. 2009 May;13(2):101-5. doi: 10.4103/0972-124X.55838.
- Background: PubMed 3866056Langer B, Langer L. Subepithelial connective tissue graft technique for root coverage. J Periodontol. 1985 Dec;56(12):715-20. doi: 10.1902/jop.1985.56.12.715.
- Individual participant dataSharing planned: Undecided. I will check with my Study Chair
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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.
Manal Hosny, PhD study chair
Cairo University
Hani El-Nahass, PhD study director
Cairo 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 Group A (Lateral closed tunnel subepithelial CT graft) and Group B (Tunnel procedure with subepithelial CT graft) in people with Gingival Recession, run by Cairo University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 6 Dec 2023. 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 Egypt. 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?
Reduction Recession Depth (time frame: 6 month). 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 NCT03791554, which also lists 21 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 6 Dec 2023.