PulpotomyNCT02393326
Biodentine Partial Pulpotomy of Pulpally Exposed Primary Molars
A study testing partial pulpotomy with biodentine and Formocresol pulpotomy in people with Pulpotomy and Tooth, Deciduous, run by Hadassah Medical Organization.
Trial summary
Objective: To compare success rates of biodentine partial pulpotomy versus formocresol pulpotomy treatment of pulpally exposed lower primary molars. After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated to a depth of 2 mm. The wound surface is irrigated and dried. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy, Tooth, Deciduous
- What is being tested?
- partial pulpotomy with biodentine and Formocresol pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Jan 2020
- 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 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The clinical criteria: primary molar with a deep carious lesion
- Sufficient tooth structure for restoration with a stainless steel crown
- No history of spontaneous pain
- Tenderness to percussion or abnormal mobility
- Abscess, fistula, or swelling of the gingiva, and with cessation of bleeding after a 2 mm depth of the pulp at the area of the exposure was amputated.
- The radiographic criteria: a deep carious lesion in close proximity to the pulp without furcation or radicular pathology
- Obliteration of the pulp and root canal, or internal or external root resorption.
- Physiologic root resorption, while included in the criteria, could not be more than one-third of the root length.
Who cannot join
- The clinical criteria: history of spontaneous pain
- Tenderness to percussion or abnormal mobility
- Abscess, fistula, or swelling of the gingiva, no cessation of bleeding after a 2 mm depth of the pulp at the area of the exposure was amputated.
- The radiographic criteria: tooth with furcation or radicular pathology
- Obliteration of the pulp and root canal, or internal or external root resorption.
- Physiologic root resorption more than one-third of the root length.
About this study
Objective: To compare success rates of biodentine partial pulpotomy versus formocresol pulpotomy treatment of pulpally exposed lower primary molars.
After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated to a depth of 2 mm. The wound surface is irrigated and dried. After homeostasis is obtained, an assistant drew lots to randomly allocate the case to either the biodentine partial pulpotomy (PP) or the formocresol pulpotomy (FP) group.
The follow-up for clinical and radiographic evaluation will be carried out at 6-month intervals.
Read the detailed description
- Prospective
- Study population: 100 patients.
- Study group: This study sample comprises mandibular primary molars from boys and girls aged between 3 and 7 years. The children have no systemic diseases according to the medical history supplied by the parents or guardians. The mandibular primary molars in this study are selected according to the following clinical and radiographic criteria. The clinical criteria: the presence of a deep carious lesion, sufficient tooth structure for restoration with a stainless steel crown, no history of spontaneous pain, tenderness to percussion or abnormal mobility, abscess, fistula, or swelling of the gingiva, and with cessation of bleeding after a 2 mm depth of the pulp at the area of the exposure was amputated. The radiographic criteria: a deep carious lesion in close proximity to the pulp without furcation or radicular pathology, obliteration of the pulp and root canal, or internal or external root resorption. Physiologic root resorption, while included in the criteria, could not be more than one-third of the root length.
- Clinical technique: All teeth will be treated under local anaesthesia with rubber dam isolation. After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated to a depth of 2 mm using a water-cooled high-speed handpiece with a #330 high-speed bur. The wound surface is irrigated with sterile saline solution and dried with cotton pellets to avoid clot formation. After homeostasis is obtained, an assistant drew lots to randomly allocate the case to either the PP or the FP treatment group. The child will not know which treatment is assigned to each tooth. For the PP group, biodentine is gently applied to the wound surface, and then covered with reinforced zinc oxide-eugenol (IRM_; Dentsply). For the FP group, coronal access is obtained using high-speed handpiece with a #330 high-speed bur with water spray to further expose the pulp chamber. Following removal of the coronal pulp and achievement of homeostasis, a cotton pellet moistened with formocresol (1: 5 Buckley's solution) is placed on the amputated pulp for 5 min. The pulp stumps is then covered by IRM. After PP or FP treatment, all teeth are restored with a stainless steel crown.
- Follow-up: the follow-up for clinical and radiographic evaluation will be carried out at 6-month intervals. Treatment is considered a clinical failure if one or more of the following signs are observed: pain, abscess or sinus opening, tenderness upon percussion, or abnormal tooth mobility. For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: furcation or periapical radiolucency, pathologic external root resorption, or internal resorption. The treatment is regarded successful if both the clinical and radiographic evaluation does not indicate any signs of failure.
- Conditions
- Pulpotomy, Tooth, Deciduous
- Being tested
- partial pulpotomy with biodentine, Formocresol pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial pulpotomy with biodentineProcedure or surgery
After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated to a depth of 2 mm. The wound surface is irrigated and dried. After homeostasis is obtained, biodentine is gently applied to the wound surface, and then covered with reinforced zinc oxide-eugenol
Formocresol pulpotomyProcedure or surgery
Following removal of the coronal pulp and achievement of homeostasis, a cotton pellet moistened with formocresol (1: 5 Buckley's solution) is placed on the amputated pulp for 5 min. The pulp stumps is then covered by IRM.
| Study group | Role | What they receive |
|---|---|---|
| Partial pulpotomy with biodentine | Experimental | Biodentine is gently applied to the pulp stumps Receives: Procedure: partial pulpotomy with biodentine |
| Formocresol pulpotomy | Other | A cotton pellet moistened with formocresol (1: 5 Buckley's solution) is placed on the amputated pulp for 5 min. Receives: Procedure: Formocresol pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
partial pulpotomy clinical success rate
Treatment is considered a clinical failure if one or more of the following signs are observed: pain, abscess or sinus opening, tenderness upon percussion, or abnormal tooth mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
Measured: 6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months
partial pulpotomy radiographic success rate
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: furcation or periapical radiolucency, pathologic external root resorption, or internal resorption. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure.
Measured: 6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months
Secondary outcomes (2)
Formocresol pulpotomy clinical success rate
Treatment is considered a clinical failure if one or more of the following signs are observed: pain, abscess or sinus opening, tenderness upon percussion, or abnormal tooth mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
Measured: 6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months
Formocresol pulpotomy radiographic success rate
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: furcation or periapical radiolucency, pathologic external root resorption, or internal resorption. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure.
Measured: 6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startJan 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: technical and funding issues
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.
- More trials run by Hadassah Medical OrganizationThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avia Fux, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393326
- Sponsor's protocol ID
- 0644-14-HMO-CTIL
- Status last verified
- Mar 2018
- First submitted
- 9 Mar 2015
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodentine Partial Pulpotomy of Pulpally Exposed Primary Molars
- ClinicalTrials.gov ID
- NCT02393326
- Acronym / sponsor ID
- 0644-14-HMO-CTIL
- Conditions
- Pulpotomy, Tooth, Deciduous
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: technical and funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 19 Mar 2015 (estimated)
- 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: To compare success rates of biodentine partial pulpotomy versus formocresol pulpotomy treatment of pulpally exposed lower primary molars.
After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated to a depth of 2 mm. The wound surface is irrigated and dried. After homeostasis is obtained, an assistant drew lots to randomly allocate the case to either the biodentine partial pulpotomy (PP) or the formocresol pulpotomy (FP) group.
The follow-up for clinical and radiographic evaluation will be carried out at 6-month intervals.
Detailed description
- Prospective
- Study population: 100 patients.
- Study group: This study sample comprises mandibular primary molars from boys and girls aged between 3 and 7 years. The children have no systemic diseases according to the medical history supplied by the parents or guardians. The mandibular primary molars in this study are selected according to the following clinical and radiographic criteria. The clinical criteria: the presence of a deep carious lesion, sufficient tooth structure for restoration with a stainless steel crown, no history of spontaneous pain, tenderness to percussion or abnormal mobility, abscess, fistula, or swelling of the gingiva, and with cessation of bleeding after a 2 mm depth of the pulp at the area of the exposure was amputated. The radiographic criteria: a deep carious lesion in close proximity to the pulp without furcation or radicular pathology, obliteration of the pulp and root canal, or internal or external root resorption. Physiologic root resorption, while included in the criteria, could not be more than one-third of the root length.
- Clinical technique: All teeth will be treated under local anaesthesia with rubber dam isolation. After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated to a depth of 2 mm using a water-cooled high-speed handpiece with a #330 high-speed bur. The wound surface is irrigated with sterile saline solution and dried with cotton pellets to avoid clot formation. After homeostasis is obtained, an assistant drew lots to randomly allocate the case to either the PP or the FP treatment group. The child will not know which treatment is assigned to each tooth. For the PP group, biodentine is gently applied to the wound surface, and then covered with reinforced zinc oxide-eugenol (IRM_; Dentsply). For the FP group, coronal access is obtained using high-speed handpiece with a #330 high-speed bur with water spray to further expose the pulp chamber. Following removal of the coronal pulp and achievement of homeostasis, a cotton pellet moistened with formocresol (1: 5 Buckley's solution) is placed on the amputated pulp for 5 min. The pulp stumps is then covered by IRM. After PP or FP treatment, all teeth are restored with a stainless steel crown.
- Follow-up: the follow-up for clinical and radiographic evaluation will be carried out at 6-month intervals. Treatment is considered a clinical failure if one or more of the following signs are observed: pain, abscess or sinus opening, tenderness upon percussion, or abnormal tooth mobility. For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: furcation or periapical radiolucency, pathologic external root resorption, or internal resorption. The treatment is regarded successful if both the clinical and radiographic evaluation does not indicate any signs of failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial pulpotomy with biodentine | Experimental | Procedure: partial pulpotomy with biodentineBiodentine is gently applied to the pulp stumps |
| Formocresol pulpotomy | Other | Procedure: Formocresol pulpotomyA cotton pellet moistened with formocresol (1: 5 Buckley's solution) is placed on the amputated pulp for 5 min. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The clinical criteria: primary molar with a deep carious lesion
- Sufficient tooth structure for restoration with a stainless steel crown
- No history of spontaneous pain
- Tenderness to percussion or abnormal mobility
- Abscess, fistula, or swelling of the gingiva, and with cessation of bleeding after a 2 mm depth of the pulp at the area of the exposure was amputated.
Key exclusion criteria (6 listed)
- The clinical criteria: history of spontaneous pain
- Tenderness to percussion or abnormal mobility
- Abscess, fistula, or swelling of the gingiva, no cessation of bleeding after a 2 mm depth of the pulp at the area of the exposure was amputated.
- The radiographic criteria: tooth with furcation or radicular pathology
- Obliteration of the pulp and root canal, or internal or external root resorption.
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 |
|---|---|---|
| partial pulpotomy with biodentineAfter caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated to a depth of 2 mm. The wound surface is irrigated and dried. After homeostasis is obtained, biodentine is gently applied to the wound surface, and then covered with reinforced zinc oxide-eugenol | Procedure or surgery | Partial pulpotomy with biodentine |
| Formocresol pulpotomyFollowing removal of the coronal pulp and achievement of homeostasis, a cotton pellet moistened with formocresol (1: 5 Buckley's solution) is placed on the amputated pulp for 5 min. The pulp stumps is then covered by IRM. | Procedure or surgery | Formocresol pulpotomy |
Primary outcome
partial pulpotomy clinical success rate
Time frame: 6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months
Treatment is considered a clinical failure if one or more of the following signs are observed: pain, abscess or sinus opening, tenderness upon percussion, or abnormal tooth mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
partial pulpotomy radiographic success rate
Time frame: 6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: furcation or periapical radiolucency, pathologic external root resorption, or internal resorption. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure.
2 secondary outcomes
Formocresol pulpotomy clinical success rate
Time frame: 6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months
Formocresol pulpotomy radiographic success rate
Time frame: 6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
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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 partial pulpotomy with biodentine and Formocresol pulpotomy in people with Pulpotomy and Tooth, Deciduous, run by Hadassah Medical Organization.
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 8 inclusion and 6 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: withdrawn, as of the sponsor's last update on 14 Mar 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
partial pulpotomy clinical success rate (time frame: 6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 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?
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 14 Mar 2018.