PulpotomyNCT04270318
Sodium Hypoclorite as an Antibacterial Agent Prior to Pulpotomies
A study testing CH Pulpotomy, physiologic saline, CH pulpotomy, NaOCl and MTA Pulpotomy, physiologic saline in people with Pulpotomy and Primary Teeth, run by Izmir Katip Celebi University.
Trial summary
Aim: The aim of this study was to report the 24-Month radiographical and histological outcome on these previously reported calcium hydroxide (CH) and mineral trioxide aggregate (MTA) pulpotomies using of five percent sodium hypochlorite (NaOCl) as an antibacterial agent to clean the chamber prior to application of the… Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy, Primary Teeth
- What is being tested?
- CH Pulpotomy, physiologic saline, CH pulpotomy, NaOCl and MTA Pulpotomy, physiologic saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Mar 2017
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Each child had at least two previously untreated lower 2nd primary mandibular molars with nearly equal carious involvement that required pulpotomies but showed positive response to vitality tests (electrical pulp test and cold stimulation)
- The children were healthy and cooperative
- Moderate response to chemical and thermal stimuli.
- Teeth would be restorable with stainless steel crowns.
Who cannot join
- Signs of irreversible pulpitis (such as spontaneous pain, prolonged pain response),
- Presence of percussion or palpation,
- Pathological mobility,
- Infectious symptoms such as fistula or abscess,
- Discoloration in the clinical examination,
- Presence of radiolucency in the furcation or periodical regions thickening of the periodontal spaces
- Internal or external root resorption.
About this study
Official title: Clinical, Radiographic, and Histologic Outcome of Sodium Hypoclorite as an Antibacterial Agent Prior to Calcium Hydroxide and Mineral Trioxide Aggregate Pulpotomies in Primary Teeth
Aim: The aim of this study was to report the 24-Month radiographical and histological outcome on these previously reported calcium hydroxide (CH) and mineral trioxide aggregate (MTA) pulpotomies using of five percent sodium hypochlorite (NaOCl) as an antibacterial agent to clean the chamber prior to application of the pulpotomy agent.
Materials and Methods: 128 primary molars were randomly divided into two main groups according to pulpotomy material (CH/MTA) and into two sub-groups according to selected the antibacterial agent (NaOCl/physiologic saline) used in the pulpotomy procedure. After these procedures, teeth were followed radiographically for 24 months. Thirty-four successfully treated teeth whose successors roots had completed formation of at least two-thirds of their lengths were extracted for histological evaluation. Fisher's-exact test, Pearson's-chi-square test and MannWhitneyU test with Bonferroni correction were used for statistical analysis.
Read the detailed description
The procedure and possible discomforts, risks, and benefits had been fully explained to the parents of the children, and informed consent forms were signed.
A total of 64 children (37 boys and 27 girls), between six to 10 years old (mean=8.2 years old) who had at least two mandibular primary molars with nearly equal carious involvement that required pulpotomy were included in the study. Following anesthesia and rubber dam isolation, the pulpotomy procedure was realized. After amputation of the coronal pulp tissue, pulpal hemorrhage was controlled using dry sterile cotton pellets under slight pressure for approximately 5 min. Four teeth were excluded from the study because of uncontrolled bleeding.
A total of 124 teeth were randomly distributed (by a coin toss) among groups representing different pulpotomy materials (CH or MTA) and cleansing agents (NaOCl or physiologic saline).
CH pulpotomy (n = 62 teeth): After hemorrhage control, two teeth in each child were randomly assigned by the toss of a coin to receive two cleansing agents, the experimental disinfecting agent 5% NaOCl (Wizard, Rehber Chemistry, Istanbul, Turkey) or the physiologic saline. CH control (n = 31 teeth): Pulp chamber was cleansed with physiologic saline prior the CH pulpotomy. CH NaOCl (n = 31 teeth): Pulp chamber was cleansed with 5% NaOCl for 30 s prior the CH pulpotomy. Then, canal orifices were sealed with CH (Kalsin, Aktu, Izmir, Turkey) paste (CH powder mixed with physiologic saline). After the canal orifice dressing, the chamber was based with reinforced ZOE (IRM; Dentsply Caulk, Milford, DE) and the tooth immediately restored with a stainless steel crown (SSC; 3M ESPE, Seefeld, Germany).
MTA pulpotomy (n = 62 teeth): As stated above, following the hemorrhage control, two cleansing agents were randomly applied to the cavity. MTA control (n= 31 teeth): Pulp chamber was cleansed with physiologic saline prior the MTA pulpotomy. MTA NaOCl (n = 31 teeth): Pulp chamber was cleansed with 5% NaOCl for 30 s prior the MTA pulpotomy. Then, canal orifices were sealed with MTA (ProRoot MTA; Dentsply, Tulsa, OK, USA) and a moistened cotton pellet was placed over the MTA paste to allow setting of the material. Reinforced ZOE was placed as a temporary restoration; the ZOE and the cotton pellets were removed after 24 h, and the teeth finally restored with SSCs.
The treatments received follow-up evaluations every six months, for 24 months, following the completion of the treatments. One examiner, who was blinded to treatment type, evaluated the teeth clinically and radiographically. At follow-up appointments, clinical success was confirmed by the absence of spontaneous pain, pathologic mobility, tenderness to percussion, swelling, fistula, or gingival inflammation. Radiographic success was considered when internal/external root resorption and periapical/furcal radiolucency was not observed. Calcific metamorphosis of the pulp was not considered a failure. The data were analyzed using Fisher's exact, McNemar, and Pearson's chi-square tests with Bonferroni correction.
Histological assessment Clinically and radiologically successful teeth -whose successors roots had completed formation of at least two thirds of their lengths- were extracted for histopathological evaluation. Following extraction, the teeth were immediately immersed in 10 % buffered formalin, embedded in paraffin, and serially sectioned through the root canals in a mesiodistal direction using a microtome to obtain sections of 5 μm in thickness. Sections were stained using hematoxylin eosin and examined under a light microscope.
- Conditions
- Pulpotomy, Primary Teeth
- Being tested
- CH Pulpotomy, physiologic saline, CH pulpotomy, NaOCl, MTA Pulpotomy, physiologic saline, MTA pulpotomy, NaOCl
- Keywords
- calcium hydroxide, mineral trioxide aggregate, sodium hypochlorite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CH Pulpotomy, physiologic salineOther
Pulp chamber was cleansed with physiologic saline for 30 s.
CH pulpotomy, NaOClOther
Pulp chamber was cleansed with 5 % NaOCl for 30 s.
MTA Pulpotomy, physiologic salineOther
Pulp chamber was cleansed with physiologic saline for 30 s.
MTA pulpotomy, NaOClOther
Pulp chamber was cleansed with 5 % NaOCl for 30 s.
| Study group | Role | What they receive |
|---|---|---|
| CH pulpotomy-control | Active comparator | After hemorrhage control, pulp chamber was cleansed with physiologic saline prior the CH pulpotomy.Then, canal orifices were sealed with CH (Kalsin, Aktu, Izmir, Turkey) paste (CH powder mixed with physiologic saline). After the canal orifice dressing, the chamber was based with reinforced ZOE (IRM; Dentsply Caulk, Milford, DE) and the tooth immediately restored with a stainless steel crown (SSC; 3M ESPE, Seefeld, Germany). Receives: Other: CH Pulpotomy, physiologic saline |
| CH pulpotomy-NaOCl | Experimental | After hemorrhage control,pulp chamber was cleansed with 5% NaOCl for 30 s prior the CH pulpotomy. Then, canal orifices were sealed with CH (Kalsin, Aktu, Izmir, Turkey) paste (CH powder mixed with physiologic saline). After the canal orifice dressing, the chamber was based with reinforced ZOE (IRM; Dentsply Caulk, Milford, DE) and the tooth immediately restored with a stainless steel crown (SSC; 3M ESPE, Seefeld, Germany). Receives: Other: CH pulpotomy, NaOCl |
| MTA pulpotomy-control | Active comparator | After hemorrhage control, pulp chamber was cleansed with physiologic saline prior the MTA pulpotomy. Then, canal orifices were sealed with MTA (ProRoot MTA; Dentsply, Tulsa, OK, USA) and a moistened cotton pellet was placed over the MTA paste to allow setting of the material. Reinforced ZOE was placed as a temporary restoration; the ZOE and the cotton pellets were removed after 24 h, and the teeth finally restored with SSCs. Receives: Other: MTA Pulpotomy, physiologic saline |
| MTA pulpotomy-NaOCl | Experimental | After hemorrhage control, pulp chamber was cleansed with physiologic saline prior the MTA pulpotomy. MTA NaOCl (n = 31 teeth): Pulp chamber was cleansed with 5% NaOCl for 30 s prior the MTA pulpotomy.
Then, canal orifices were sealed with MTA (ProRoot MTA; Dentsply, Tulsa, OK, USA) and a moistened cotton pellet was placed over the MTA paste to allow setting of the material. Reinforced ZOE was placed as a temporary restoration; the ZOE and the cotton pellets were removed after 24 h, and the teeth finally restored with SSCs. Receives: Other: MTA pulpotomy, NaOCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate of pulpotomy
Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of spontaneous pain, pathologic mobility, tenderness to percussion, swelling, fistula, or gingival inflammation. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
Measured: Change of clinical success from baseline at 12 month
Clinical success rate of pulpotomy
Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of spontaneous pain, pathologic mobility, tenderness to percussion, swelling, fistula, or gingival inflammation. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
Measured: Change of clinical success from Baseline at 24 month
Radiographic success rate of pulpotomy
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure.
success was considered when internal/external root resorption and periapical/furcal radiolucency was not observed.
Measured: Change of radiographicsuccess from baseline at 12 month
Radiographic success rate of pulpotomy
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure.
success was considered when internal/external root resorption and periapical/furcal radiolucency was not observed.
Measured: Change of radiographicsuccess from baseline at 24 month
Secondary outcomes (1)
Histological success rate of indirect pulp treatment
For histologic evaluation, the treatment is rated as a failure when one or more of the following signs are present: absent of the integrity of the odontoblastic layer, absent of tertiary dentin formation, presence of pulpitis, presence of fibrosis and dystrophic calcification. The treatment is regarded successful if histologic evaluation does not indicate any signs of failure.
Measured: up to 30 months (the teeth were extracted in regular exfoliation period (in which the underlying permanent tooth germ had completed 2/3 of root formation).]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study startSep 2012
- Primary completionJul 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpotomyStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve AKCAY, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270318
- Sponsor's protocol ID
- 2012-TEZ-07
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic, and Histologic Outcome of Sodium Hypoclorite as an Antibacterial Agent Prior to Calcium Hydroxide and Mineral Trioxide Aggregate Pulpotomies in Primary Teeth
- ClinicalTrials.gov ID
- NCT04270318
- Acronym / sponsor ID
- 2012-TEZ-07
- Conditions
- Pulpotomy, Primary Teeth
- Keywords
- calcium hydroxide, mineral trioxide aggregate, sodium hypochlorite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Feb 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.
Aim: The aim of this study was to report the 24-Month radiographical and histological outcome on these previously reported calcium hydroxide (CH) and mineral trioxide aggregate (MTA) pulpotomies using of five percent sodium hypochlorite (NaOCl) as an antibacterial agent to clean the chamber prior to application of the pulpotomy agent.
Materials and Methods: 128 primary molars were randomly divided into two main groups according to pulpotomy material (CH/MTA) and into two sub-groups according to selected the antibacterial agent (NaOCl/physiologic saline) used in the pulpotomy procedure. After these procedures, teeth were followed radiographically for 24 months. Thirty-four successfully treated teeth whose successors roots had completed formation of at least two-thirds of their lengths were extracted for histological evaluation. Fisher's-exact test, Pearson's-chi-square test and MannWhitneyU test with Bonferroni correction were used for statistical analysis.
Detailed description
The procedure and possible discomforts, risks, and benefits had been fully explained to the parents of the children, and informed consent forms were signed.
A total of 64 children (37 boys and 27 girls), between six to 10 years old (mean=8.2 years old) who had at least two mandibular primary molars with nearly equal carious involvement that required pulpotomy were included in the study. Following anesthesia and rubber dam isolation, the pulpotomy procedure was realized. After amputation of the coronal pulp tissue, pulpal hemorrhage was controlled using dry sterile cotton pellets under slight pressure for approximately 5 min. Four teeth were excluded from the study because of uncontrolled bleeding.
A total of 124 teeth were randomly distributed (by a coin toss) among groups representing different pulpotomy materials (CH or MTA) and cleansing agents (NaOCl or physiologic saline).
CH pulpotomy (n = 62 teeth): After hemorrhage control, two teeth in each child were randomly assigned by the toss of a coin to receive two cleansing agents, the experimental disinfecting agent 5% NaOCl (Wizard, Rehber Chemistry, Istanbul, Turkey) or the physiologic saline. CH control (n = 31 teeth): Pulp chamber was cleansed with physiologic saline prior the CH pulpotomy. CH NaOCl (n = 31 teeth): Pulp chamber was cleansed with 5% NaOCl for 30 s prior the CH pulpotomy. Then, canal orifices were sealed with CH (Kalsin, Aktu, Izmir, Turkey) paste (CH powder mixed with physiologic saline). After the canal orifice dressing, the chamber was based with reinforced ZOE (IRM; Dentsply Caulk, Milford, DE) and the tooth immediately restored with a stainless steel crown (SSC; 3M ESPE, Seefeld, Germany).
MTA pulpotomy (n = 62 teeth): As stated above, following the hemorrhage control, two cleansing agents were randomly applied to the cavity. MTA control (n= 31 teeth): Pulp chamber was cleansed with physiologic saline prior the MTA pulpotomy. MTA NaOCl (n = 31 teeth): Pulp chamber was cleansed with 5% NaOCl for 30 s prior the MTA pulpotomy. Then, canal orifices were sealed with MTA (ProRoot MTA; Dentsply, Tulsa, OK, USA) and a moistened cotton pellet was placed over the MTA paste to allow setting of the material. Reinforced ZOE was placed as a temporary restoration; the ZOE and the cotton pellets were removed after 24 h, and the teeth finally restored with SSCs.
The treatments received follow-up evaluations every six months, for 24 months, following the completion of the treatments. One examiner, who was blinded to treatment type, evaluated the teeth clinically and radiographically. At follow-up appointments, clinical success was confirmed by the absence of spontaneous pain, pathologic mobility, tenderness to percussion, swelling, fistula, or gingival inflammation. Radiographic success was considered when internal/external root resorption and periapical/furcal radiolucency was not observed. Calcific metamorphosis of the pulp was not considered a failure. The data were analyzed using Fisher's exact, McNemar, and Pearson's chi-square tests with Bonferroni correction.
Histological assessment Clinically and radiologically successful teeth -whose successors roots had completed formation of at least two thirds of their lengths- were extracted for histopathological evaluation. Following extraction, the teeth were immediately immersed in 10 % buffered formalin, embedded in paraffin, and serially sectioned through the root canals in a mesiodistal direction using a microtome to obtain sections of 5 μm in thickness. Sections were stained using hematoxylin eosin and examined under a light microscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CH pulpotomy-control | Active comparator | Other: CH Pulpotomy, physiologic salineAfter hemorrhage control, pulp chamber was cleansed with physiologic saline prior the CH pulpotomy.Then, canal orifices were sealed with CH (Kalsin, Aktu, Izmir, Turkey) paste (CH powder mixed with physiologic saline). After the canal orifice dressing, the chamber was based with reinforced ZOE (IRM; Dentsply Caulk, Milford, DE) and the tooth immediately restored with a stainless steel crown (SSC; 3M ESPE, Seefeld, Germany). |
| CH pulpotomy-NaOCl | Experimental | Other: CH pulpotomy, NaOClAfter hemorrhage control,pulp chamber was cleansed with 5% NaOCl for 30 s prior the CH pulpotomy. Then, canal orifices were sealed with CH (Kalsin, Aktu, Izmir, Turkey) paste (CH powder mixed with physiologic saline). After the canal orifice dressing, the chamber was based with reinforced ZOE (IRM; Dentsply Caulk, Milford, DE) and the tooth immediately restored with a stainless steel crown (SSC; 3M ESPE, Seefeld, Germany). |
| MTA pulpotomy-control | Active comparator | Other: MTA Pulpotomy, physiologic salineAfter hemorrhage control, pulp chamber was cleansed with physiologic saline prior the MTA pulpotomy. Then, canal orifices were sealed with MTA (ProRoot MTA; Dentsply, Tulsa, OK, USA) and a moistened cotton pellet was placed over the MTA paste to allow setting of the material. Reinforced ZOE was placed as a temporary restoration; the ZOE and the cotton pellets were removed after 24 h, and the teeth finally restored with SSCs. |
| MTA pulpotomy-NaOCl | Experimental | Other: MTA pulpotomy, NaOClAfter hemorrhage control, pulp chamber was cleansed with physiologic saline prior the MTA pulpotomy. MTA NaOCl (n = 31 teeth): Pulp chamber was cleansed with 5% NaOCl for 30 s prior the MTA pulpotomy. Then, canal orifices were sealed with MTA (ProRoot MTA; Dentsply, Tulsa, OK, USA) and a moistened cotton pellet was placed over the MTA paste to allow setting of the material. Reinforced ZOE was placed as a temporary restoration; the ZOE and the cotton pellets were removed after 24 h, and the teeth finally restored with SSCs. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Each child had at least two previously untreated lower 2nd primary mandibular molars with nearly equal carious involvement that required pulpotomies but showed positive response to vitality tests (electrical pulp test and cold stimulation)
- The children were healthy and cooperative
- Moderate response to chemical and thermal stimuli.
- Teeth would be restorable with stainless steel crowns.
Key exclusion criteria (7 listed)
- Signs of irreversible pulpitis (such as spontaneous pain, prolonged pain response),
- Presence of percussion or palpation,
- Pathological mobility,
- Infectious symptoms such as fistula or abscess,
- Discoloration in the clinical examination,
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 |
|---|---|---|
| CH Pulpotomy, physiologic salinePulp chamber was cleansed with physiologic saline for 30 s. | Other | CH pulpotomy-control |
| CH pulpotomy, NaOClPulp chamber was cleansed with 5 % NaOCl for 30 s. | Other | CH pulpotomy-NaOCl |
| MTA Pulpotomy, physiologic salinePulp chamber was cleansed with physiologic saline for 30 s. | Other | MTA pulpotomy-control |
| MTA pulpotomy, NaOClPulp chamber was cleansed with 5 % NaOCl for 30 s. | Other | MTA pulpotomy-NaOCl |
Primary outcome
Clinical success rate of pulpotomy
Time frame: Change of clinical success from baseline at 12 month
Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of spontaneous pain, pathologic mobility, tenderness to percussion, swelling, fistula, or gingival inflammation. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
Clinical success rate of pulpotomy
Time frame: Change of clinical success from Baseline at 24 month
Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of spontaneous pain, pathologic mobility, tenderness to percussion, swelling, fistula, or gingival inflammation. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
Radiographic success rate of pulpotomy
Time frame: Change of radiographicsuccess from baseline at 12 month
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure. success was considered when internal/external root resorption and periapical/furcal radiolucency was not observed.
Radiographic success rate of pulpotomy
Time frame: Change of radiographicsuccess from baseline at 24 month
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure. success was considered when internal/external root resorption and periapical/furcal radiolucency was not observed.
1 secondary outcome
Histological success rate of indirect pulp treatment
Time frame: up to 30 months (the teeth were extracted in regular exfoliation period (in which the underlying permanent tooth germ had completed 2/3 of root formation).]
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 17 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CH Pulpotomy, physiologic saline, CH pulpotomy, NaOCl and MTA Pulpotomy, physiologic saline in people with Pulpotomy and Primary Teeth, run by Izmir Katip Celebi University.
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 4 inclusion and 7 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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 of pulpotomy (time frame: Change of clinical success from baseline at 12 month). 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?
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 17 Feb 2020.