Pulpal Bleeding; StainingNCT06403306
Evaluation of Pulpotomy Success of Different Methods
A study testing Ferric Sulfate (Viskostat; Ultradent, Utah, USA), Ankaferd Blood Stopper (Ankaferd Blood Stopper, Ankaferd Ilaç Kozmetik A.S, Istanbul, Turkey) and Er,Cr:YSGG laser (Waterlase MD, Biolase, USA) in people with Pulpal Bleeding; Staining and Primary Teeth, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Considering the lack of data in the literature concerning the success of Er,Cr:YSGG laser in pulpotomy treatment of primary teeth, the present study aimed to compare this laser system with two different chemical hemostatic agents regarding its clinical and radiographic success. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpal Bleeding; Staining, Primary Teeth, Pulpotomy
- What is being tested?
- Ferric Sulfate (Viskostat; Ultradent, Utah, USA), Ankaferd Blood Stopper (Ankaferd Blood Stopper, Ankaferd Ilaç Kozmetik A.S, Istanbul, Turkey) and Er,Cr:YSGG laser (Waterlase MD, Biolase, USA)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 1 Oct 2019
- 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- deep dentin caries, lack of spontaneous pain, no sensitivity to percussion and palpation
- no soft tissue pathologies such as edema, fistula, abscess
- mechanical exposure greater than pinpoint, carious exposure,
- suitability for restoration with stainless steel crowns
- healthy lamina dura and periodontal space, no radiographic pathologies in the interradicular and periapical regions, no pathological external and internal resorption, and no calcified masses within the pulp
- mandibular primary molar
Who cannot join
- maxiller primary molar
- teeth with radiographic pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of the Success of Er,Cr:YSGG Laser Pulpotomy With Ferric Sulfate and Ankaferd in Primary Molar Teeth
Considering the lack of data in the literature concerning the success of Er,Cr:YSGG laser in pulpotomy treatment of primary teeth, the present study aimed to compare this laser system with two different chemical hemostatic agents regarding its clinical and radiographic success.
Read the detailed description
The study was carried on 65 patients (33 females and 32 males) with ages ranging between 5-9 years and having no systemic disease. Inclusion criteria were as follows; deep dentin caries, lack of spontaneous pain, no sensitivity to percussion and palpation, no soft tissue pathologies such as edema, fistula, abscess, mechanical exposure greater than pinpoint, carious exposure, suitability for restoration with stainless steel crowns, healthy lamina dura and periodontal space, no radiographic pathologies in the interradicular and periapical regions, no pathological external and internal resorption, and no calcified masses within the pulp. Only the mandibular primary molars were included in the study to evaluate the roots better radiologically. A single physician performed all patients' treatments. Following administration of local anesthesia, the teeth were isolated by a rubber dam. The carious enamel tissue was removed and the cavities were formed using a high-speed rotary instrument under water cooling. The carious dentin was removed using a low-speed rotary instrument and steel round bur. In the teeth included in the study, after opening the access cavity, the coronal pulp was removed with a sharp, sterile excavator and low-speed rotary instrument, and the pulp chamber was rinsed with saline. Primary bleeding control was provided in all groups by applying moisturized sterile cotton pellets over the canal orifices for five minutes with minimal pressure. The teeth in which bleeding could not be controlled within five minutes were excluded from the study, and root canal treatment was performed in these teeth. In the teeth that bleeding control was provided, FS, ABS, or Er,Cr:YSGG laser applications were made according to the order on the randomization list.
Following the primary bleeding control, the FS solution was kept in the cavity for 15 seconds using cotton pellets in the FS group. The ABS solution drawn from the 1 ml ampoule to the syringe according to the manufacturer's instructions, was kept in the cavity for 15 seconds using cotton pellets in the ABS group. In the laser group, both the physician and the patient wore protective glasses before the procedure. Er,Cr:YSGG laser (Waterlase MD, Biolase, USA) was applied in a non-contact manner on the pulp tissue. In all groups, after secondary bleeding control, the pulp chamber was sealed with zinc oxide -eugenol (ZOE). Glass ionomer cement was applied over the ZOE base and teeth were restored with stainless steel crown. Following the treatment, the patients were called for follow-up examinations at intervals of 3 months for 12 months.
- Conditions
- Pulpal Bleeding; Staining, Primary Teeth, Pulpotomy
- Being tested
- Ferric Sulfate (Viskostat; Ultradent, Utah, USA), Ankaferd Blood Stopper (Ankaferd Blood Stopper, Ankaferd Ilaç Kozmetik A.S, Istanbul, Turkey), Er,Cr:YSGG laser (Waterlase MD, Biolase, USA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Sulfate (Viskostat; Ultradent, Utah, USA)Drug
Also called Viskostat
Widely used in pulpotomy treatment of primary teeth, provides hemostasis through a chemical reaction with blood. The metal-protein complex, formed due to contact with blood, creates a mechanical plug; thus, hemostasis occurs without clot formation.
Ankaferd Blood Stopper (Ankaferd Blood Stopper, Ankaferd Ilaç Kozmetik A.S, Istanbul, Turkey)Drug
Also called not
Recently introduced to clinical practice as an alternative to FS, is a herbal hemostatic agent. It consists of a standardized mixture of Thymus vulgaris (thyme), Alpinia officinarum (galangal), Vitis vinifera (vine), Glycyrrhiza glabra (licorice) and Urtica dioica (nettle).
Er,Cr:YSGG laser (Waterlase MD, Biolase, USA)Device
Also called Waterlase
Alternative technique introduced to clinical practice in recent years to provide hemostasis in vital pulp treatment is the usage of lasers in various wavelengths. Using lasers in pulpotomy provides many advantages such as tissue vaporization and coagulation, maintenance of a blood-free working field due to its property to close small blood vessels, minimal clot formation, and sterilization of the wound surface. Furthermore, laser systems were reported to induce cellular biostimulation. Er,Cr:YSGG lasers which belong to the Erbium laser family are the laser systems with the highest absorption rate by water, having a wavelength of 2780 nm. Besides, Erbium lasers manifest bactericidal effects.
| Study group | Role | What they receive |
|---|---|---|
| Ferric Sulfate | Active comparator | Ferric Sulfate (FS), widely used in pulpotomy treatment of primary teeth, provides hemostasis through a chemical reaction with blood. The FS solution was kept in the cavity for 15 seconds using cotton pellets in the FS group. Receives: Drug: Ferric Sulfate (Viskostat; Ultradent, Utah, USA) |
| Ankaferd Blood Stopper | Experimental | Ankaferd Blood Stopper (ABS), recently introduced to clinical practice as an alternative to FS, is a herbal hemostatic agent. The ABS solution drawn from the 1 ml ampoule to the syringe according to the manufacturer's instructions, was kept in the cavity for 15 seconds using cotton pellets in the ABS group. Receives: Drug: Ankaferd Blood Stopper (Ankaferd Blood Stopper, Ankaferd Ilaç Kozmetik A.S, Istanbul, Turkey) |
| Er,Cr:YSGG laser | Experimental | Er,Cr:YSGG laser was applied in a non-contact manner on the pulp tissue from a distance of 3-4 mm for ten seconds, with an energy intensity of 25 mL, output power of 0.5 W, and frequency of 20 Hz. The MZ6 laser tip was used for application. Receives: Device: Er,Cr:YSGG laser (Waterlase MD, Biolase, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate
In clinical examination, treatment was considered unsuccessful when one of the following findings were detected: Spontaneous pain, tenderness to percussion and palpation, fistula formation, soft tissue swelling, and pathological mobility. In teeth in which treatment was considered unsuccessful, root canal treatment or extraction was performed according to the cause of the failure. When indicated, a space maintainer was applied following extraction.
Measured: Following the treatment, the patients were called for follow-up examinations at intervals of 3 months for 12 months.
Radiographic success rate
In the radiological examination, presence of periapical and/or interradicular radiolucency, widening of the periodontal ligament, loss of lamina dura, the presence of internal or external pathological resorption were considered as failure. In teeth in which treatment was considered unsuccessful, root canal treatment or extraction was performed according to the cause of the failure. When indicated, a space maintainer was applied following extraction.
Measured: Following the treatment, the patients were called for follow-up examinations at intervals of 3 months for 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Apr 2018
- Primary completion1 Apr 2018
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulpal Bleeding; StainingStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NECIBE DAMLA ŞAHIN, Tokat Gaziosmanpasa University
- Investigators
- Volkan Arıkan, Study director, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403306
- Sponsor's protocol ID
- 2018/08
- Status last verified
- May 2024
- First submitted
- 27 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodd HD, Waterhouse PJ, Fuks AB, Fayle SA, Moffat MA; British Society of Paediatric Dentistry. Pulp therapy for primary molars. Int J Paediatr Dent. 2006 Sep;16 Suppl 1:15-23. doi: 10.1111/j.1365-263X.2006.00774.x. No abstract available.
PubMed 16939452Vargas KG, Packham B, Lowman D. Preliminary evaluation of sodium hypochlorite for pulpotomies in primary molars. Pediatr Dent. 2006 Nov-Dec;28(6):511-7.
PubMed 17249432Goker H, Haznedaroglu IC, Ercetin S, Kirazli S, Akman U, Ozturk Y, Firat HC. Haemostatic actions of the folkloric medicinal plant extract Ankaferd Blood Stopper. J Int Med Res. 2008 Jan-Feb;36(1):163-70. doi: 10.1177/147323000803600121.
PubMed 18304416Chandran V, Ramanarayanan V, Menon M, Varma B, Sanjeevan V. Effect of LASER therapy Vs conventional techniques on clinical and radiographic outcomes of deciduous molar pulpotomy: A systematic review and meta-analysis. J Clin Exp Dent. 2020 Jun 1;12(6):e588-e596. doi: 10.4317/jced.56436. eCollection 2020 Jun.
PubMed 32665819Cengiz E, Yilmaz HG. Efficacy of Erbium, Chromium-doped:Yttrium, Scandium, Gallium, and Garnet Laser Irradiation Combined with Resin-based Tricalcium Silicate and Calcium Hydroxide on Direct Pulp Capping: A Randomized Clinical Trial. J Endod. 2016 Mar;42(3):351-5. doi: 10.1016/j.joen.2015.11.015. Epub 2015 Dec 23.
PubMed 26723484Betancourt P, Merlos A, Sierra JM, Camps-Font O, Arnabat-Dominguez J, Vinas M. Effectiveness of low concentration of sodium hypochlorite activated by Er,Cr:YSGG laser against Enterococcus faecalis biofilm. Lasers Med Sci. 2019 Mar;34(2):247-254. doi: 10.1007/s10103-018-2578-6. Epub 2018 Jul 6.
PubMed 29980946Fahim SZ, Ghali RM, Hashem AA, Farid MM. The efficacy of 2780 nm Er,Cr;YSGG and 940 nm Diode Laser in root canal disinfection: A randomized clinical trial. Clin Oral Investig. 2024 Feb 26;28(3):175. doi: 10.1007/s00784-024-05563-z.
PubMed 38403667
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Success of Er,Cr:YSGG Laser Pulpotomy With Ferric Sulfate and Ankaferd in Primary Molar Teeth
- ClinicalTrials.gov ID
- NCT06403306
- Acronym / sponsor ID
- 2018/08
- Conditions
- Pulpal Bleeding; Staining, Primary Teeth, Pulpotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 7 May 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.
Considering the lack of data in the literature concerning the success of Er,Cr:YSGG laser in pulpotomy treatment of primary teeth, the present study aimed to compare this laser system with two different chemical hemostatic agents regarding its clinical and radiographic success.
Detailed description
The study was carried on 65 patients (33 females and 32 males) with ages ranging between 5-9 years and having no systemic disease. Inclusion criteria were as follows; deep dentin caries, lack of spontaneous pain, no sensitivity to percussion and palpation, no soft tissue pathologies such as edema, fistula, abscess, mechanical exposure greater than pinpoint, carious exposure, suitability for restoration with stainless steel crowns, healthy lamina dura and periodontal space, no radiographic pathologies in the interradicular and periapical regions, no pathological external and internal resorption, and no calcified masses within the pulp. Only the mandibular primary molars were included in the study to evaluate the roots better radiologically. A single physician performed all patients' treatments. Following administration of local anesthesia, the teeth were isolated by a rubber dam. The carious enamel tissue was removed and the cavities were formed using a high-speed rotary instrument under water cooling. The carious dentin was removed using a low-speed rotary instrument and steel round bur. In the teeth included in the study, after opening the access cavity, the coronal pulp was removed with a sharp, sterile excavator and low-speed rotary instrument, and the pulp chamber was rinsed with saline. Primary bleeding control was provided in all groups by applying moisturized sterile cotton pellets over the canal orifices for five minutes with minimal pressure. The teeth in which bleeding could not be controlled within five minutes were excluded from the study, and root canal treatment was performed in these teeth. In the teeth that bleeding control was provided, FS, ABS, or Er,Cr:YSGG laser applications were made according to the order on the randomization list.
Following the primary bleeding control, the FS solution was kept in the cavity for 15 seconds using cotton pellets in the FS group. The ABS solution drawn from the 1 ml ampoule to the syringe according to the manufacturer's instructions, was kept in the cavity for 15 seconds using cotton pellets in the ABS group. In the laser group, both the physician and the patient wore protective glasses before the procedure. Er,Cr:YSGG laser (Waterlase MD, Biolase, USA) was applied in a non-contact manner on the pulp tissue. In all groups, after secondary bleeding control, the pulp chamber was sealed with zinc oxide -eugenol (ZOE). Glass ionomer cement was applied over the ZOE base and teeth were restored with stainless steel crown. Following the treatment, the patients were called for follow-up examinations at intervals of 3 months for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ferric Sulfate | Active comparator | Drug: Ferric Sulfate (Viskostat; Ultradent, Utah, USA)Ferric Sulfate (FS), widely used in pulpotomy treatment of primary teeth, provides hemostasis through a chemical reaction with blood. The FS solution was kept in the cavity for 15 seconds using cotton pellets in the FS group. |
| Ankaferd Blood Stopper | Experimental | Drug: Ankaferd Blood Stopper (Ankaferd Blood Stopper, Ankaferd Ilaç Kozmetik A.S, Istanbul, Turkey)Ankaferd Blood Stopper (ABS), recently introduced to clinical practice as an alternative to FS, is a herbal hemostatic agent. The ABS solution drawn from the 1 ml ampoule to the syringe according to the manufacturer's instructions, was kept in the cavity for 15 seconds using cotton pellets in the ABS group. |
| Er,Cr:YSGG laser | Experimental | Device: Er,Cr:YSGG laser (Waterlase MD, Biolase, USA)Er,Cr:YSGG laser was applied in a non-contact manner on the pulp tissue from a distance of 3-4 mm for ten seconds, with an energy intensity of 25 mL, output power of 0.5 W, and frequency of 20 Hz. The MZ6 laser tip was used for application. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- deep dentin caries, lack of spontaneous pain, no sensitivity to percussion and palpation
- no soft tissue pathologies such as edema, fistula, abscess
- mechanical exposure greater than pinpoint, carious exposure,
- suitability for restoration with stainless steel crowns
- healthy lamina dura and periodontal space, no radiographic pathologies in the interradicular and periapical regions, no pathological external and internal resorption, and no calcified masses within the pulp
Key exclusion criteria (2 listed)
- maxiller primary molar
- teeth with radiographic pathology
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 |
|---|---|---|
| Ferric Sulfate (Viskostat; Ultradent, Utah, USA)Also: ViskostatWidely used in pulpotomy treatment of primary teeth, provides hemostasis through a chemical reaction with blood. The metal-protein complex, formed due to contact with blood, creates a mechanical plug; thus, hemostasis occurs without clot formation. | Drug | Ferric Sulfate |
| Ankaferd Blood Stopper (Ankaferd Blood Stopper, Ankaferd Ilaç Kozmetik A.S, Istanbul, Turkey)Also: notRecently introduced to clinical practice as an alternative to FS, is a herbal hemostatic agent. It consists of a standardized mixture of Thymus vulgaris (thyme), Alpinia officinarum (galangal), Vitis vinifera (vine), Glycyrrhiza glabra (licorice) and Urtica dioica (nettle). | Drug | Ankaferd Blood Stopper |
| Er,Cr:YSGG laser (Waterlase MD, Biolase, USA)Also: WaterlaseAlternative technique introduced to clinical practice in recent years to provide hemostasis in vital pulp treatment is the usage of lasers in various wavelengths. Using lasers in pulpotomy provides many advantages such as tissue vaporization and coagulation, maintenance of a blood-free working field due to its property to close small blood vessels, minimal clot formation, and sterilization of the wound surface. Furthermore, laser systems were reported to induce cellular biostimulation. Er,Cr:YSGG lasers which belong to the Erbium laser family are the laser systems with the highest absorption rate by water, having a wavelength of 2780 nm. Besides, Erbium lasers manifest bactericidal effects. | Device | Er,Cr:YSGG laser |
Primary outcome
Clinical success rate
Time frame: Following the treatment, the patients were called for follow-up examinations at intervals of 3 months for 12 months.
In clinical examination, treatment was considered unsuccessful when one of the following findings were detected: Spontaneous pain, tenderness to percussion and palpation, fistula formation, soft tissue swelling, and pathological mobility. In teeth in which treatment was considered unsuccessful, root canal treatment or extraction was performed according to the cause of the failure. When indicated, a space maintainer was applied following extraction.
Radiographic success rate
Time frame: Following the treatment, the patients were called for follow-up examinations at intervals of 3 months for 12 months.
In the radiological examination, presence of periapical and/or interradicular radiolucency, widening of the periodontal ligament, loss of lamina dura, the presence of internal or external pathological resorption were considered as failure. In teeth in which treatment was considered unsuccessful, root canal treatment or extraction was performed according to the cause of the failure. When indicated, a space maintainer was applied following extraction.
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 7 May 2024.
- Background: PubMed 16939452Rodd HD, Waterhouse PJ, Fuks AB, Fayle SA, Moffat MA; British Society of Paediatric Dentistry. Pulp therapy for primary molars. Int J Paediatr Dent. 2006 Sep;16 Suppl 1:15-23. doi: 10.1111/j.1365-263X.2006.00774.x. No abstract available.
- Background: PubMed 17249432Vargas KG, Packham B, Lowman D. Preliminary evaluation of sodium hypochlorite for pulpotomies in primary molars. Pediatr Dent. 2006 Nov-Dec;28(6):511-7.
- Background: PubMed 18304416Goker H, Haznedaroglu IC, Ercetin S, Kirazli S, Akman U, Ozturk Y, Firat HC. Haemostatic actions of the folkloric medicinal plant extract Ankaferd Blood Stopper. J Int Med Res. 2008 Jan-Feb;36(1):163-70. doi: 10.1177/147323000803600121.
- Background: PubMed 32665819Chandran V, Ramanarayanan V, Menon M, Varma B, Sanjeevan V. Effect of LASER therapy Vs conventional techniques on clinical and radiographic outcomes of deciduous molar pulpotomy: A systematic review and meta-analysis. J Clin Exp Dent. 2020 Jun 1;12(6):e588-e596. doi: 10.4317/jced.56436. eCollection 2020 Jun.
- Background: PubMed 26723484Cengiz E, Yilmaz HG. Efficacy of Erbium, Chromium-doped:Yttrium, Scandium, Gallium, and Garnet Laser Irradiation Combined with Resin-based Tricalcium Silicate and Calcium Hydroxide on Direct Pulp Capping: A Randomized Clinical Trial. J Endod. 2016 Mar;42(3):351-5. doi: 10.1016/j.joen.2015.11.015. Epub 2015 Dec 23.
- Background: PubMed 29980946Betancourt P, Merlos A, Sierra JM, Camps-Font O, Arnabat-Dominguez J, Vinas M. Effectiveness of low concentration of sodium hypochlorite activated by Er,Cr:YSGG laser against Enterococcus faecalis biofilm. Lasers Med Sci. 2019 Mar;34(2):247-254. doi: 10.1007/s10103-018-2578-6. Epub 2018 Jul 6.
- Background: PubMed 38403667Fahim SZ, Ghali RM, Hashem AA, Farid MM. The efficacy of 2780 nm Er,Cr;YSGG and 940 nm Diode Laser in root canal disinfection: A randomized clinical trial. Clin Oral Investig. 2024 Feb 26;28(3):175. doi: 10.1007/s00784-024-05563-z.
- Individual participant dataSharing planned: No
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.
Volkan Arıkan study director
Kırıkkale 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 Ferric Sulfate (Viskostat; Ultradent, Utah, USA), Ankaferd Blood Stopper (Ankaferd Blood Stopper, Ankaferd Ilaç Kozmetik A.S, Istanbul, Turkey) and Er,Cr:YSGG laser (Waterlase MD, Biolase, USA) in people with Pulpal Bleeding; Staining and Primary Teeth, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 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 7 May 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 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?
Clinical success rate (time frame: Following the treatment, the patients were called for follow-up examinations at intervals of 3 months for 12 months.). The study lists 2 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 NCT06403306, which also lists 7 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 May 2024.