Tooth, DeciduousNCT03220360
Application of Different Biomaterials in the Preservation of Vital Pulp in Carious Deciduous Teeth
A study testing indirect pulp capping, direct pulp capping and vital pulpotomy in people with Tooth, Deciduous, run by Chengdu Maternal and Children's Health Care Hospital.
Trial summary
To compare the efficacies of MTA, calcium hydroxide preparation, Biodentine and TheraCal LC that are commonly used in pediatric dentistry in the preservation of vital pulp in carious deciduous teeth. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth, Deciduous
- What is being tested?
- indirect pulp capping, direct pulp capping and vital pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to Sep 2018
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Indirect pulp capping or direct pulp capping: (1) Patients from Chengdu Maternal and Child Center, China; (2) Age between 4 and 7 years old; (3) The affected teeth present healthy periodontal occlusion or adjacent deep caries; (4) no history of spontaneous pain, root length more than 2/3, without periapical lesions and sinus; (5) written informed consent is provided by parents or guardian after they indicate that they fully understand the treatment plan.
- Vital pulpotomy: (1) Patients from Chengdu Maternal and Child Center, China; (2) Age between 3 and 8 years old; (3) mandibular deciduous molars with deep caries; (4) all the affected teeth are in the stable phase of tooth root; (5) written informed consent is provided by parents or guardian after they indicate that they fully understand the treatment plan.
- Blank control teeth: (1) The normal teeth on the opposite side of the teeth will be chosen as blank controls; (2) no dental caries; (3) X-ray films reveal that bifurcation and periapical area do not present shadow, and tooth root is also in stable period; (4) written informed consent is provided by parents or guardian after they indicate that they fully understand the treatment plan.
Who cannot join
- Patients with one or more of the following conditions will be excluded from this study.
- Dental pulp lesions, tooth resorption, pulp calcification, root tip or root furcation.
About this study
Official title: Application of Different Biomaterials in the Preservation of Vital Pulp in Carious Deciduous Teeth: a Prospective, Single-center, Randomized, Controlled Clinical Trial
To compare the efficacies of MTA, calcium hydroxide preparation, Biodentine and TheraCal LC that are commonly used in pediatric dentistry in the preservation of vital pulp in carious deciduous teeth.
Read the detailed description
In recent years, the importance of deciduous teeth and the hazards of caries in deciduous teeth have gradually attracted the attention of professionals and parents of children. The dental pulp disease and periapical disease of deciduous teeth are the main and important factors that cause deciduous teeth defects, deciduous dentition and mixed dentition deletion, which have a serious impact on the physical and mental health of children from the local or systemic aspects. From the point of view of children's stomatology, according to the principle of treatment of dental caries of deciduous teeth, vital pulp preservation should be selected in patients with deep caries and reversible pulpitis; This concept has been carried forward especially after the advent of new materials with good biocompatibility and good edge sealing. After judging the existing state of the affected teeth (such as deep caries or reversible pulpitis) and removal of caries, indirect pulp capping, direct pulp capping, and vital pulpotomy can be correspondingly selected. Complete healthy pulp can be preserved in indirect pulp capping and direct pulp capping. During vital pulpotomy, coronal pulp due to infection induced by various causes is removed, and healthy root pulp is retained.
The success of the preservation of vital pulp in carious deciduous teeth depends not only on determining the health status of the pulp, but also on selecting the most suitable pulp capping agent. No matter the use of calcium hydroxide and mineral trioxide aggregate (MTA) or new biomaterials, controlling pulp inflammation and preserving healthy pulp are the keys to successful treatment. The clinical reality is that it is not easy to determine the state of the pulp accurately because of the child's feelings of pain and the unreliability of the description. Thus, the secondary treatment can be easily produced after treatment. For example, pulp re-infection requires dental pulp extraction; or severe infection results in removal of the affected teeth and space maintenance. In the face of this reality, many clinicians will advise parents to select dental pulp extraction for deciduous teeth at the first visit. If there is a reliable clinical pathway for the preservation of the vital pulp of the carious deciduous teeth, the doctor will put aside his worries. Therefore, this study is designed to find a suitable clinical pathway and to increase the success rate of the preservation of the vital pulp of carious deciduous teeth. The key to solving this problem lies in the selection of suitable pulp capping agent, as well as the repair method of the crown selection to obtain a better edge sealing. Numerous studies have confirmed that crown repair of deciduous teeth can obtain better edge sealing on the basis of obtaining the largest degree of morphological restoration. The difficulty and key point are to select the best biomaterials as the pulp capping agents for the preservation of vital pulp.
The investigators will select classical and new biomaterials for the preservation of vital pulp and compare them so as to select a pulp capping agent with high success rate. With the further research of biomedical ceramic materials, such as restorative material for pulposis Bioaggregate and restorative material to dentin Biodentine, the biocompatibility of such materials allows the destructed dental pulp tissue to be reconstructed. Shayegan et al. performed vital pulpotomy for pigs using Biodentine, white MTA and formaldehyde cresol as pulp capping agents, and using Biodentine, white MTA and calcium hydroxide as direct pulp capping, and observed the response to dental pulp tissue. They concluded that Biodentine and white MTA have the same biocompatibility, and they are suitable for the pulp capping material of porcine deciduous teeth. In recent years, TheraCal LC has emerged as a new type of pulp capping agent. Some scholars believed that both MTA and TheraCal are good indirect pulp capping materials. TheraCal has better operability and similar chemical property as MTA. In the indirect pulp capping treatment of deciduous teeth, TheraCal can be a successful alternative to MTA. Nevertheless, TheraCal is rarely used in direct pulp capping, and vital pulpotomy.
In summary, this study will select Biodentine and TheraCal, verify their efficacies, and explore their superiorities. Calcium hydroxide and MTA will be selected as controls, which will be separately used in indirect pulp capping, direct pulp capping, and vital pulpotomy to provide reliable choices for clinicians.
- Conditions
- Tooth, Deciduous
- Being tested
- indirect pulp capping, direct pulp capping, vital pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indirect pulp cappingProcedure or surgery
Sixty children with deep caries of deciduous teeth underwent indirect pulp capping and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group.
direct pulp cappingProcedure or surgery
Sixty children with deep caries of deciduous teeth underwent direct pulp capping and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group.
vital pulpotomyProcedure or surgery
Forty-five children with deep caries of deciduous teeth underwent vital pulpotomy and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group.
| Study group | Role | What they receive |
|---|---|---|
| indirect pulp capping group | Experimental | Sixty children with deep caries of deciduous teeth underwent indirect pulp capping, and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group. Receives: Procedure: indirect pulp capping |
| direct pulp capping group | Experimental | Sixty children with deep caries of deciduous teeth underwent direct pulp capping, and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group. Receives: Procedure: direct pulp capping |
| vital pulpotomy group | Experimental | Forty-five children with deep caries of deciduous teeth underwent vital pulpotomy, and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group. Receives: Procedure: vital pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
image findings
To observe thickness of reparative dentin. Image data are processed by XCP technology, scanned and transferred to a computer for digital analysis, preoperative reference value is used as the basis.
Measured: at month 12 after surgery
Secondary outcomes (1)
degree of root resorption
Degree of root resorption: ①Zero: no abnormal root resorption; ②mild: root resorption accounts for less than 1/4 of root length; ③moderate: root resorption accounts for 1/4-1/2 of root length; ④severe: root resorption accounts for more than 1/2 of root length.
Measured: at month 12 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Jun 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth, DeciduousStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Maternal and Children's Health Care Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohong Ma, Chengdu Maternal and Children's Health Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220360
- Sponsor's protocol ID
- ChengduMCHCH-001
- Status last verified
- Jul 2017
- First submitted
- 14 Jul 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Different Biomaterials in the Preservation of Vital Pulp in Carious Deciduous Teeth: a Prospective, Single-center, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03220360
- Acronym / sponsor ID
- ChengduMCHCH-001
- Conditions
- Tooth, Deciduous
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Chengdu Maternal and Children's Health Care HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 18 Jul 2017 (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.
To compare the efficacies of MTA, calcium hydroxide preparation, Biodentine and TheraCal LC that are commonly used in pediatric dentistry in the preservation of vital pulp in carious deciduous teeth.
Detailed description
In recent years, the importance of deciduous teeth and the hazards of caries in deciduous teeth have gradually attracted the attention of professionals and parents of children. The dental pulp disease and periapical disease of deciduous teeth are the main and important factors that cause deciduous teeth defects, deciduous dentition and mixed dentition deletion, which have a serious impact on the physical and mental health of children from the local or systemic aspects. From the point of view of children's stomatology, according to the principle of treatment of dental caries of deciduous teeth, vital pulp preservation should be selected in patients with deep caries and reversible pulpitis; This concept has been carried forward especially after the advent of new materials with good biocompatibility and good edge sealing. After judging the existing state of the affected teeth (such as deep caries or reversible pulpitis) and removal of caries, indirect pulp capping, direct pulp capping, and vital pulpotomy can be correspondingly selected. Complete healthy pulp can be preserved in indirect pulp capping and direct pulp capping. During vital pulpotomy, coronal pulp due to infection induced by various causes is removed, and healthy root pulp is retained.
The success of the preservation of vital pulp in carious deciduous teeth depends not only on determining the health status of the pulp, but also on selecting the most suitable pulp capping agent. No matter the use of calcium hydroxide and mineral trioxide aggregate (MTA) or new biomaterials, controlling pulp inflammation and preserving healthy pulp are the keys to successful treatment. The clinical reality is that it is not easy to determine the state of the pulp accurately because of the child's feelings of pain and the unreliability of the description. Thus, the secondary treatment can be easily produced after treatment. For example, pulp re-infection requires dental pulp extraction; or severe infection results in removal of the affected teeth and space maintenance. In the face of this reality, many clinicians will advise parents to select dental pulp extraction for deciduous teeth at the first visit. If there is a reliable clinical pathway for the preservation of the vital pulp of the carious deciduous teeth, the doctor will put aside his worries. Therefore, this study is designed to find a suitable clinical pathway and to increase the success rate of the preservation of the vital pulp of carious deciduous teeth. The key to solving this problem lies in the selection of suitable pulp capping agent, as well as the repair method of the crown selection to obtain a better edge sealing. Numerous studies have confirmed that crown repair of deciduous teeth can obtain better edge sealing on the basis of obtaining the largest degree of morphological restoration. The difficulty and key point are to select the best biomaterials as the pulp capping agents for the preservation of vital pulp.
The investigators will select classical and new biomaterials for the preservation of vital pulp and compare them so as to select a pulp capping agent with high success rate. With the further research of biomedical ceramic materials, such as restorative material for pulposis Bioaggregate and restorative material to dentin Biodentine, the biocompatibility of such materials allows the destructed dental pulp tissue to be reconstructed. Shayegan et al. performed vital pulpotomy for pigs using Biodentine, white MTA and formaldehyde cresol as pulp capping agents, and using Biodentine, white MTA and calcium hydroxide as direct pulp capping, and observed the response to dental pulp tissue. They concluded that Biodentine and white MTA have the same biocompatibility, and they are suitable for the pulp capping material of porcine deciduous teeth. In recent years, TheraCal LC has emerged as a new type of pulp capping agent. Some scholars believed that both MTA and TheraCal are good indirect pulp capping materials. TheraCal has better operability and similar chemical property as MTA. In the indirect pulp capping treatment of deciduous teeth, TheraCal can be a successful alternative to MTA. Nevertheless, TheraCal is rarely used in direct pulp capping, and vital pulpotomy.
In summary, this study will select Biodentine and TheraCal, verify their efficacies, and explore their superiorities. Calcium hydroxide and MTA will be selected as controls, which will be separately used in indirect pulp capping, direct pulp capping, and vital pulpotomy to provide reliable choices for clinicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| indirect pulp capping group | Experimental | Procedure: indirect pulp cappingSixty children with deep caries of deciduous teeth underwent indirect pulp capping, and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group. |
| direct pulp capping group | Experimental | Procedure: direct pulp cappingSixty children with deep caries of deciduous teeth underwent direct pulp capping, and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group. |
| vital pulpotomy group | Experimental | Procedure: vital pulpotomyForty-five children with deep caries of deciduous teeth underwent vital pulpotomy, and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Indirect pulp capping or direct pulp capping: (1) Patients from Chengdu Maternal and Child Center, China; (2) Age between 4 and 7 years old; (3) The affected teeth present healthy periodontal occlusion or adjacent deep caries; (4) no history of spontaneous pain, root length more than 2/3, without periapical lesions and sinus; (5) written informed consent is provided by parents or guardian after they indicate that they fully understand the treatment plan.
- Vital pulpotomy: (1) Patients from Chengdu Maternal and Child Center, China; (2) Age between 3 and 8 years old; (3) mandibular deciduous molars with deep caries; (4) all the affected teeth are in the stable phase of tooth root; (5) written informed consent is provided by parents or guardian after they indicate that they fully understand the treatment plan.
- Blank control teeth: (1) The normal teeth on the opposite side of the teeth will be chosen as blank controls; (2) no dental caries; (3) X-ray films reveal that bifurcation and periapical area do not present shadow, and tooth root is also in stable period; (4) written informed consent is provided by parents or guardian after they indicate that they fully understand the treatment plan.
Key exclusion criteria (2 listed)
- Patients with one or more of the following conditions will be excluded from this study.
- Dental pulp lesions, tooth resorption, pulp calcification, root tip or root furcation.
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 |
|---|---|---|
| indirect pulp cappingSixty children with deep caries of deciduous teeth underwent indirect pulp capping and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group. | Procedure or surgery | indirect pulp capping group |
| direct pulp cappingSixty children with deep caries of deciduous teeth underwent direct pulp capping and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group. | Procedure or surgery | direct pulp capping group |
| vital pulpotomyForty-five children with deep caries of deciduous teeth underwent vital pulpotomy and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group. | Procedure or surgery | vital pulpotomy group |
Primary outcome
image findings
Time frame: at month 12 after surgery
To observe thickness of reparative dentin. Image data are processed by XCP technology, scanned and transferred to a computer for digital analysis, preoperative reference value is used as the basis.
1 secondary outcome
degree of root resorption
Time frame: at month 12 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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 indirect pulp capping, direct pulp capping and vital pulpotomy in people with Tooth, Deciduous, run by Chengdu Maternal and Children's Health Care Hospital.
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 3 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: status not confirmed, as of the sponsor's last update on 18 Jul 2017. 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?
Results are not available in the source record.
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?
image findings (time frame: at month 12 after surgery). 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 18 Jul 2017.