Papilla ReconstructionT-PRFNCT07746622
Gingival Graft vs T-PRF in Papilla Defects
A study testing De-epithelialized gingival graft and Titanium-prepared Platelet-Rich Fibrin in people with Papilla Reconstruction, run by Pamukkale University at 2 sites in Turkey (Türkiye).
Trial summary
Objective: Titanium-prepared platelet-rich fibrin (T-PRF) has emerged as a promising biomaterial in periodontal regenerative procedures. The aim of this study will be to compare the clinical effectiveness of de-epithelialized gingival grafts (DGG) and T-PRF in the reconstruction of deficient interdental papillae using… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Papilla Reconstruction
- What is being tested?
- De-epithelialized gingival graft and Titanium-prepared Platelet-Rich Fibrin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 14 Mar 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 25 and 70 years.
- Presence of papilla loss in the anterior region of the maxilla or mandible.
- Classification of papilla loss as Class 1 or 2
- Absence of systemic diseases.
- No bleeding disorders that could interfere with the surgery.
- Non-smoker and non-alcohol consumer.
Show all 9Show fewer
- Not pregnant or breastfeeding.
- Absence of fillings, prostheses, or root canal treatments in the relevant teeth.
- No prior surgical interventions in the target area.
Who cannot join
- Smoking or alcohol consumption.
- Presence of systemic diseases
- Patients who did not attend postoperative follow-up appointments regularly.
- Pregnant or breastfeeding individuals.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Pamukkale University Faculty of Dentistry
Denizli, Denizli, 20160
Faculty of Dentistry, Pamukkale University
Denizli, Pamukkale, 20160
About this study
Official title: Comparison of De-epithelialized Gingival Graft and Titanium-Prepared Platelet-Rich Fibrin in Interdental Papilla Defects: A Randomized Controlled Trial
Objective: Titanium-prepared platelet-rich fibrin (T-PRF) has emerged as a promising biomaterial in periodontal regenerative procedures. The aim of this study will be to compare the clinical effectiveness of de-epithelialized gingival grafts (DGG) and T-PRF in the reconstruction of deficient interdental papillae using the tunnel technique.
Methods: A total of 34 patients presenting with 115 Class I and II interdental papilla defects will be enrolled in this study. Interdental papilla reconstruction will be performed using the tunnel technique in combination with either DGG or T-PRF. Demographic characteristics (age and sex), dentogingival variables (tooth shape, papilla location, jaw type, and papilla loss classification), and clinical parameters will be recorded. Clinical assessments will include probing depth (PD), gingival index (GI), plaque index (PI), gingival thickness (GT), keratinized tissue height (KTH), black triangle width (BTW), black triangle height (BTH), papilla fill percentage (%PF), and black triangle area (BTA). All clinical parameters will be assessed at baseline and at 1, 3, and 6 months following surgery.
Read the detailed description
This randomized controlled clinical trial aims to evaluate the clinical efficacy of two autogenous grafting materials, de-epithelialized gingival graft (DGG) and titanium-prepared platelet-rich fibrin (T-PRF), when used in combination with the tunnel technique for interdental papilla reconstruction (IPR).
Interdental papilla defects may cause esthetic concerns, food impaction, and phonetic difficulties. Several surgical and non-surgical methods have been proposed for IPR. Connective tissue grafts (CTG) are considered the gold standard in many periodontal procedures; however, they require a second surgical site and are associated with increased patient discomfort. As alternatives, several types of PRF have been developed; however, T-PRF demonstrates superior properties, including improved biocompatibility and prolonged growth factor release.
The study is designed as a parallel-group randomized controlled trial. Thirty-four participants with Class I or II interdental papilla defects were included and randomly assigned to one of two groups:
Control Group: tunnel technique combined with DGG
Test Group: tunnel technique combined with T-PRF membrane
Surgical procedures were performed by the same operator, while measurements were obtained by a blinded examiner. Clinical parameters will be evaluated preoperatively and at 1, 3, and 6 months postoperatively.
Inclusion criteria include participants aged 25-70 years with papilla loss in the anterior maxilla or mandible, systemically healthy, non-smokers, and with no previous surgery in the target area. Exclusion criteria include smoking, systemic diseases, pregnancy or breastfeeding, and poor compliance with follow-up visits.
Prior to the surgical procedure, all participants received Phase I periodontal therapy, including comprehensive oral hygiene instructions. Participants were re-evaluated during follow-up visits, and those meeting the inclusion criteria were subsequently enrolled in the surgical phase.
Surgical Procedure The surgical procedure involves papilla reconstruction using the tunnel technique. Sulcular and horizontal incisions are made to create a half-thickness tunnel flap. De-epithelialized gingival grafts or T-PRF membranes are prepared according to standardized protocols and placed into the prepared papillary voids. Grafts are stabilized using guiding sutures, and tension-free closure of the flap is achieved. Postoperative care includes pain management, antimicrobial therapy, and oral hygiene instructions.
Measurement of Demographic, Dentogingival, and Clinical Parameters Demographic and dentogingival data, including age, gender, crown shape, papilla classification, jaw type, and papilla area, will be recorded. Clinical parameters assessed preoperatively and at follow-up include probing depth, gingival index, plaque index, gingival thickness, keratinized tissue height, black triangle height and width, papilla fill percentage, and black triangle area. Standardized measurement techniques and calibrated instruments will be used to ensure accuracy and reproducibility.
Statistical Analysis Data will be analyzed using Statistical Package for the Social Sciences and Jamovi software application. Normality will be assessed using Shapiro-Wilk and Kolmogorov-Smirnov tests. Between-group comparisons will use Mann-Whitney U test, and categorical data will be evaluated using Fisher's Exact Test or Yates correction. Repeated measures will be analyzed using Robust ANOVA. Statistical significance will be set at p < 0.05.
- Conditions
- Papilla Reconstruction
- Being tested
- De-epithelialized gingival graft, Titanium-prepared Platelet-Rich Fibrin
- Keywords
- De-epithelialized gingival graft, Titanium-prepared Platelet-Rich Fibrin, Han and Takei technique, interdental papilla loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-epithelialized gingival graftProcedure or surgery
Papilla reconstruction was performed using the tunnel technique. Sulcular and horizontal incisions on the alveolar mucosa were made with a No. 15c scalpel, extending to the mid-buccal regions of the adjacent teeth. A partial-thickness tunnel flap was prepared using specialized tunneling instruments, with careful preservation of papillary integrity. Additional sulcular incisions were made on the palatal side, and the tunnel was extended beneath the carefully elevated palatal flap. De-epithelialized gingival graft material was inserted from the palatal aspect using a leader suture and guided through the tunnel to exit via the horizontal incision. It was then positioned and stabilized beneath the papillary tissue. Finally, suspension sutures were used to coronally advance the flap, which was secured to preoperatively prepared provisional composite splints to ensure tension-free closure.
Titanium-prepared Platelet-Rich FibrinProcedure or surgery
Papilla reconstruction was performed using the tunnel technique. Sulcular and horizontal incisions on the alveolar mucosa were made with a No. 15c scalpel, extending to the mid-buccal regions of the adjacent teeth. A partial-thickness tunnel flap was prepared using specialized tunneling instruments, with careful preservation of papillary integrity. Additional sulcular incisions were made on the palatal side, and the tunnel was extended beneath the carefully elevated palatal flap. A Titanium-Prepared Platelet-Rich Fibrin (T-PRF) graft was introduced from the palatal aspect using a leader suture and guided through the tunnel to exit via the horizontal incision. The graft was positioned and stabilized beneath the papillary tissue. Finally, suspension sutures were used to coronally advance the flap, which was secured to preoperatively prepared provisional composite splints to ensure tension-free closure.
| Study group | Role | What they receive |
|---|---|---|
| De-epithelialized gingival graft | Active comparator | Participants assigned to this group received papilla reconstruction using a de-epithelialized gingival graft harvested from the palatal mucosa. Following tunnel preparation via the tunnel technique, the graft was de-epithelialized to a thickness of approximately 1.5 mm and inserted beneath the papillary flap to fill the defect. Graft stabilization and coronal advancement of the flap were achieved using suspension sutures anchored to preoperatively placed composite splints. Receives: Procedure: De-epithelialized gingival graft |
| Titanium-prepared Platelet-Rich Fibrin | Active comparator | In this group, T-PRF membranes were prepared by centrifuging autologous blood in grade IV titanium tubes at 2,800 rpm for 12 minutes. The resulting fibrin clots were compressed to create standardized membranes, which were folded and placed into the prepared tunnel beneath the papilla. Similar to the DGG group, the flap was coronally repositioned and stabilized using suspension sutures attached to composite splints. Receives: Procedure: Titanium-prepared Platelet-Rich Fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
black triangle height
The distance between the lowest point of the interdental contact area of teeth adjacent to the papilla and the highest point of the gingival papilla was measured.
Measured: preoperative and postoperative (1, 3, 6 months)
black triangle width
The distance between the contact points of the papilla apex and the two adjacent teeth.
Measured: preoperative and postoperative (1, 3, 6 months)
black triangle area
BTA was calculated as the area between the interdental contact points of the teeth and the gingival papilla using the formula:
BTA= (BTH x BTW) /2
Measured: preoperative and postoperative (1, 3, 6 months)
% Percentage fill
The percentage change in black triangle height between two time intervals was calculated using the formula:
%PD=(tendBTH - tfirstBTH) /tendBTH x100
Measured: preoperative and postoperative 6 months
Secondary outcomes (2)
keratinized tissue height
The distance between the interdental papilla apex and the mucogingival junction was measured using a periodontal probe
Measured: preoperative and postoperative (1, 3, 6 months)
Gingival thickness
Gingival thickness was measured at the center of the interdental papilla area. A No. 20 spreader was inserted perpendicularly into the gingival tissue at a distance of 3 mm from the papilla apex until contact with the bone surface, and tissue thickness was calculated using a stopper. Measurements were taken with a digital caliper for precision.
Measured: preoperative and postoperative (1, 3, 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start15 Nov 2022
- Primary completion14 Feb 2023
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Papilla ReconstructionStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makbule Can, Pamukkale University
- Investigators
- Makbule CAN, Res. asst., Principal investigator, Pamukkale University Faculty of Dentistry, Denizli, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746622
- Sponsor's protocol ID
- 2023/06
- Acronym
- T-PRF
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharma E, Sharma A, Singh K. The role of subepithelial connective tissue graft for reconstruction of interdental papilla: Clinical study. Singapore Dent J. 2017 Dec;38:27-38. doi: 10.1016/j.sdj.2017.05.001.
PubMed 29229072
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of De-epithelialized Gingival Graft and Titanium-Prepared Platelet-Rich Fibrin in Interdental Papilla Defects: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07746622
- Acronym / sponsor ID
- T-PRF / 2023/06
- Conditions
- Papilla Reconstruction
- Keywords
- De-epithelialized gingival graft, Titanium-prepared Platelet-Rich Fibrin, Han and Takei technique, interdental papilla loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 5 Aug 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.
Objective: Titanium-prepared platelet-rich fibrin (T-PRF) has emerged as a promising biomaterial in periodontal regenerative procedures. The aim of this study will be to compare the clinical effectiveness of de-epithelialized gingival grafts (DGG) and T-PRF in the reconstruction of deficient interdental papillae using the tunnel technique.
Methods: A total of 34 patients presenting with 115 Class I and II interdental papilla defects will be enrolled in this study. Interdental papilla reconstruction will be performed using the tunnel technique in combination with either DGG or T-PRF. Demographic characteristics (age and sex), dentogingival variables (tooth shape, papilla location, jaw type, and papilla loss classification), and clinical parameters will be recorded. Clinical assessments will include probing depth (PD), gingival index (GI), plaque index (PI), gingival thickness (GT), keratinized tissue height (KTH), black triangle width (BTW), black triangle height (BTH), papilla fill percentage (%PF), and black triangle area (BTA). All clinical parameters will be assessed at baseline and at 1, 3, and 6 months following surgery.
Detailed description
This randomized controlled clinical trial aims to evaluate the clinical efficacy of two autogenous grafting materials, de-epithelialized gingival graft (DGG) and titanium-prepared platelet-rich fibrin (T-PRF), when used in combination with the tunnel technique for interdental papilla reconstruction (IPR).
Interdental papilla defects may cause esthetic concerns, food impaction, and phonetic difficulties. Several surgical and non-surgical methods have been proposed for IPR. Connective tissue grafts (CTG) are considered the gold standard in many periodontal procedures; however, they require a second surgical site and are associated with increased patient discomfort. As alternatives, several types of PRF have been developed; however, T-PRF demonstrates superior properties, including improved biocompatibility and prolonged growth factor release.
The study is designed as a parallel-group randomized controlled trial. Thirty-four participants with Class I or II interdental papilla defects were included and randomly assigned to one of two groups:
Control Group: tunnel technique combined with DGG
Test Group: tunnel technique combined with T-PRF membrane
Surgical procedures were performed by the same operator, while measurements were obtained by a blinded examiner. Clinical parameters will be evaluated preoperatively and at 1, 3, and 6 months postoperatively.
Inclusion criteria include participants aged 25-70 years with papilla loss in the anterior maxilla or mandible, systemically healthy, non-smokers, and with no previous surgery in the target area. Exclusion criteria include smoking, systemic diseases, pregnancy or breastfeeding, and poor compliance with follow-up visits.
Prior to the surgical procedure, all participants received Phase I periodontal therapy, including comprehensive oral hygiene instructions. Participants were re-evaluated during follow-up visits, and those meeting the inclusion criteria were subsequently enrolled in the surgical phase.
Surgical Procedure The surgical procedure involves papilla reconstruction using the tunnel technique. Sulcular and horizontal incisions are made to create a half-thickness tunnel flap. De-epithelialized gingival grafts or T-PRF membranes are prepared according to standardized protocols and placed into the prepared papillary voids. Grafts are stabilized using guiding sutures, and tension-free closure of the flap is achieved. Postoperative care includes pain management, antimicrobial therapy, and oral hygiene instructions.
Measurement of Demographic, Dentogingival, and Clinical Parameters Demographic and dentogingival data, including age, gender, crown shape, papilla classification, jaw type, and papilla area, will be recorded. Clinical parameters assessed preoperatively and at follow-up include probing depth, gingival index, plaque index, gingival thickness, keratinized tissue height, black triangle height and width, papilla fill percentage, and black triangle area. Standardized measurement techniques and calibrated instruments will be used to ensure accuracy and reproducibility.
Statistical Analysis Data will be analyzed using Statistical Package for the Social Sciences and Jamovi software application. Normality will be assessed using Shapiro-Wilk and Kolmogorov-Smirnov tests. Between-group comparisons will use Mann-Whitney U test, and categorical data will be evaluated using Fisher's Exact Test or Yates correction. Repeated measures will be analyzed using Robust ANOVA. Statistical significance will be set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| De-epithelialized gingival graft | Active comparator | Procedure: De-epithelialized gingival graftParticipants assigned to this group received papilla reconstruction using a de-epithelialized gingival graft harvested from the palatal mucosa. Following tunnel preparation via the tunnel technique, the graft was de-epithelialized to a thickness of approximately 1.5 mm and inserted beneath the papillary flap to fill the defect. Graft stabilization and coronal advancement of the flap were achieved using suspension sutures anchored to preoperatively placed composite splints. |
| Titanium-prepared Platelet-Rich Fibrin | Active comparator | Procedure: Titanium-prepared Platelet-Rich FibrinIn this group, T-PRF membranes were prepared by centrifuging autologous blood in grade IV titanium tubes at 2,800 rpm for 12 minutes. The resulting fibrin clots were compressed to create standardized membranes, which were folded and placed into the prepared tunnel beneath the papilla. Similar to the DGG group, the flap was coronally repositioned and stabilized using suspension sutures attached to composite splints. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 25 and 70 years.
- Presence of papilla loss in the anterior region of the maxilla or mandible.
- Classification of papilla loss as Class 1 or 2
- Absence of systemic diseases.
- No bleeding disorders that could interfere with the surgery.
Key exclusion criteria (4 listed)
- Smoking or alcohol consumption.
- Presence of systemic diseases
- Patients who did not attend postoperative follow-up appointments regularly.
- Pregnant or breastfeeding individuals.
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 |
|---|---|---|
| De-epithelialized gingival graftPapilla reconstruction was performed using the tunnel technique. Sulcular and horizontal incisions on the alveolar mucosa were made with a No. 15c scalpel, extending to the mid-buccal regions of the adjacent teeth. A partial-thickness tunnel flap was prepared using specialized tunneling instruments, with careful preservation of papillary integrity. Additional sulcular incisions were made on the palatal side, and the tunnel was extended beneath the carefully elevated palatal flap. De-epithelialized gingival graft material was inserted from the palatal aspect using a leader suture and guided through the tunnel to exit via the horizontal incision. It was then positioned and stabilized beneath the papillary tissue. Finally, suspension sutures were used to coronally advance the flap, which was secured to preoperatively prepared provisional composite splints to ensure tension-free closure. | Procedure or surgery | De-epithelialized gingival graft |
| Titanium-prepared Platelet-Rich FibrinPapilla reconstruction was performed using the tunnel technique. Sulcular and horizontal incisions on the alveolar mucosa were made with a No. 15c scalpel, extending to the mid-buccal regions of the adjacent teeth. A partial-thickness tunnel flap was prepared using specialized tunneling instruments, with careful preservation of papillary integrity. Additional sulcular incisions were made on the palatal side, and the tunnel was extended beneath the carefully elevated palatal flap. A Titanium-Prepared Platelet-Rich Fibrin (T-PRF) graft was introduced from the palatal aspect using a leader suture and guided through the tunnel to exit via the horizontal incision. The graft was positioned and stabilized beneath the papillary tissue. Finally, suspension sutures were used to coronally advance the flap, which was secured to preoperatively prepared provisional composite splints to ensure tension-free closure. | Procedure or surgery | Titanium-prepared Platelet-Rich Fibrin |
Primary outcome
black triangle height
Time frame: preoperative and postoperative (1, 3, 6 months)
The distance between the lowest point of the interdental contact area of teeth adjacent to the papilla and the highest point of the gingival papilla was measured.
black triangle width
Time frame: preoperative and postoperative (1, 3, 6 months)
The distance between the contact points of the papilla apex and the two adjacent teeth.
black triangle area
Time frame: preoperative and postoperative (1, 3, 6 months)
BTA was calculated as the area between the interdental contact points of the teeth and the gingival papilla using the formula: BTA= (BTH x BTW) /2
% Percentage fill
Time frame: preoperative and postoperative 6 months
The percentage change in black triangle height between two time intervals was calculated using the formula: %PD=(tendBTH - tfirstBTH) /tendBTH x100
2 secondary outcomes
keratinized tissue height
Time frame: preoperative and postoperative (1, 3, 6 months)
Gingival thickness
Time frame: preoperative and postoperative (1, 3, 6 months)
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 5 Aug 2026.
- Results publication: PubMed 29229072Sharma E, Sharma A, Singh K. The role of subepithelial connective tissue graft for reconstruction of interdental papilla: Clinical study. Singapore Dent J. 2017 Dec;38:27-38. doi: 10.1016/j.sdj.2017.05.001.
- 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.
Makbule CAN, Res. asst. principal investigator
Pamukkale University Faculty of Dentistry, Denizli, Turkey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing De-epithelialized gingival graft and Titanium-prepared Platelet-Rich Fibrin in people with Papilla Reconstruction, run by Pamukkale University at 2 sites 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 9 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 5 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 2 sites 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?
black triangle height (time frame: preoperative and postoperative (1, 3, 6 months)). 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 NCT07746622, which also lists 1 linked publication.
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 5 Aug 2026.