Dental Caries Extending to PulpEarly Phase 1NCT03254290
Color Stability of NeoMTA Pulpotomized Primary Teeth
A Early Phase 1 study testing NeoMTA and Formocresol in people with Dental Caries Extending to Pulp, run by Texas A & M University Baylor College Of Dentistry.
Trial summary
This randomized control study will use 15 pediatric subjects selected from the patient population in the pediatric dental clinic at Children's Medical Center Dental Clinic (CMC Dental Clinic). Read more about this study
- Who is it for?
- Ages 30 months to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries Extending to Pulp
- What is being tested?
- NeoMTA and Formocresol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 30 Jun 2018
- Phase
- Early Phase 1
- 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 30 months to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between the ages of 2 ½ and 9 years of age and be ASA I or ASA II. Patient must have two, primary teeth that are matched for, size of carious lesion (same level of approximation of carious lesion to the pulp) and are that are treatment planned for a pulpotomy. The teeth selected for the study must be vital and asymptomatic both clinically and radiographically or only display symptoms consistent with reversible pulptitis The teeth selected for the study must be anticipated to be retained in the mouth for at least eighteen months
Who cannot join
- Teeth with a history of spontaneous pain. Teeth with radiographic evidence of internal or external resorption, intraradicular or periapical bone loss, loss of lamina dura, or widening of the periodontal ligament space
About this study
This randomized control study will use 15 pediatric subjects selected from the patient population in the pediatric dental clinic at Children's Medical Center Dental Clinic (CMC Dental Clinic). The study will use a within-subject control design whereby one tooth will be treated with a pulpotomy using the new formulation of MTA (NeoMTA Plus, Avalon Biomed Inc., Bradenton, FL, USA) and restored with a multi-surface composite, and the other tooth with a formocresol pulpotomy and restored with a multi-surface composite; thus, approximately 15 teeth will be treated for each treatment group. The specific treated tooth will be randomized as to which side will receive the MTA or formocresol using sealed, opaque envelopes. Approximately 15 subjects will be needed for the study in order to elicit any significant findings as demonstrated by a power analysis.
Read the detailed description
Each of the 15 patients will represent a pair of teeth. Within a given patient, assignment of the first tooth to either treatment will be determined randomly by selecting a sealed, opaque envelope with a designated treatment, with another tooth being assigned to the other treatment. All patients must demonstrate sufficient cooperation for treatment and follow-up radiographs. All procedures, possible risks or discomforts, in addition to possible benefits will be explained to the parents of all patients involved, and informed consent will be obtained from each parent.
The goal will consist of completing all treatment in one appointment; however, in the event that all treatment is unable to be completed, for example, local anesthetic limitations, the patient will be scheduled for the next available appointment, keeping them as close together as possible.
Patients will be anesthetized with local anesthesia, and treatment will be performed utilizing rubber dam isolation. The pulpotomy procedure will include removal of the carious tooth structure using a high-speed carbide bur and water spray. When the removal of carious tooth structure results in pulp exposure, the roof of the chamber will be removed. A high-speed handpiece and sterile spoon excavator will be used to remove the coronal pulp tissue. The amputation site will be cleaned and hemostasis obtained with a wet cotton pellet. The site will then be treated with either a slurry of NeoMTA Plus according to the manufacturer's directions or traditional Formocresol according to the manufacturer's directions. The remaining pulp chamber will be filled with a visible light cured resin-reinforced glass ionomer and will then receive a multi-surface composite final restoration
- Conditions
- Dental Caries Extending to Pulp
- Being tested
- NeoMTA, Formocresol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoMTABiological
A new formulation of MTA was developed in which bismuth oxide was omitted.
FormocresolBiological
Control group
| Study group | Role | What they receive |
|---|---|---|
| Experimental NeoMTA | Experimental | The new formulation of MTA (does not contain bismuth oxide) will be used in one tooth receiving a pulpotomy to determine if the color of the tooth changes over time.The new formulation has received the FDAs 510(k) substantial equivalence clearance for Class II dental materials and is equivalent to its MTA predicate (ProRoot, Dentsply Tulsa Dental, Tulsa, OK, USA). Receives: Biological: NeoMTA; Biological: Formocresol |
| Formocresol | Active comparator | Control group. This group will receive the "gold standard" formulation of a formocresol pulpotomy. Receives: Biological: Formocresol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color stability
color scale (0=white/still esthetic; 1=slightly gray; 2=medium gray color; 3=dark gray
Measured: 3 month recall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start1 Oct 2017 (estimated)
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Dental Caries Extending to PulpStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Children between the ages of 2 ½ and 9 years of age and be ASA I or ASA II. Patient must have two, primary teeth that are matched for, size of carious lesion (same level of approximation of carious lesion to the pulp) and are that are treatment planned for a pulpotomy. The teeth selected for the study must be vital and asymptomatic both clinically and radiographically or only display symptoms consistent with reversible pulptitis The teeth selected for the study must be anticipated to be retained in the mouth for at least eighteen months
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas A & M University Baylor College Of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn A. Kerins DDS, Texas A & M University Baylor College Of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254290
- Sponsor's protocol ID
- TexasAMBaylor
- Status last verified
- Aug 2017
- First submitted
- 15 Aug 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Agamy HA, Bakry NS, Mounir MM, Avery DR. Comparison of mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth. Pediatr Dent. 2004 Jul-Aug;26(4):302-9.
PubMed 15344622Farsi N, Alamoudi N, Balto K, Mushayt A. Success of mineral trioxide aggregate in pulpotomized primary molars. J Clin Pediatr Dent. 2005 Summer;29(4):307-11. doi: 10.17796/jcpd.29.4.n80t77w625118k73.
PubMed 16161395Holan G, Eidelman E, Fuks AB. Long-term evaluation of pulpotomy in primary molars using mineral trioxide aggregate or formocresol. Pediatr Dent. 2005 Mar-Apr;27(2):129-36.
PubMed 15926290Jabbarifar SE, Khademi D, Ghasemi D. Success rates of formocresol pulpotomy versus mineral trioxide aggregate in human primary molar tooth. J Res Med Sci 2004; 9(6)L 55-8.
Peng L, Ye L, Tan H, Zhou X. Evaluation of the formocresol versus mineral trioxide aggregate primary molar pulpotomy: a meta-analysis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Dec;102(6):e40-4. doi: 10.1016/j.tripleo.2006.05.017. Epub 2006 Sep 26.
PubMed 17138165Farooq NS, Coll JA, Kuwabara A, Shelton P. Success rates of formocresol pulpotomy and indirect pulp therapy in the treatment of deep dentinal caries in primary teeth. Pediatr Dent. 2000 Jul-Aug;22(4):278-86.
PubMed 10969431Guelmann M, Fair J, Bimstein E. Permanent versus temporary restorations after emergency pulpotomies in primary molars. Pediatr Dent. 2005 Nov-Dec;27(6):478-81.
PubMed 16532888Holan G, Fuks AB, Ketlz N. Success rate of formocresol pulpotomy in primary molars restored with stainless steel crown vs amalga. Pediatr Dent. 2002 May-Jun;24(3):212-6.
PubMed 12064493Seale NS. The use of stainless steel crowns. Pediatr Dent. 2002 Sep-Oct;24(5):501-5.
PubMed 12412965Caceda JH. The use of resin-based composite restorations in pulpotomized primary molars. J Dent Child (Chic). 2007 May-Aug;74(2):147-50.
PubMed 18477438Cehreli ZC, Cetinguc A, Cengiz SB, Altay AN. Clinical performance of pulpotomized primary molars restored with resin-based materials. 24-month results. Am J Dent. 2006 Oct;19(5):262-6.
PubMed 17073200Guelmann M, Bookmyer KL, Villalta P, Garcia-Godoy F. Microleakage of restorative techniques for pulpotomized primary molars. J Dent Child (Chic). 2004 Sep-Dec;71(3):209-11.
PubMed 15871455Guelmann M, McIlwain MF, Primosch RE. Radiographic assessment of primary molar pulpotomies restored with resin-based materials. Pediatr Dent. 2005 Jan-Feb;27(1):24-7.
PubMed 15839391Hutcheson C, Seale NS, McWhorter A, Kerins C, Wright J. Multi-surface composite vs stainless steel crown restorations after mineral trioxide aggregate pulpotomy: a randomized controlled trial. Pediatr Dent. 2012 Nov-Dec;34(7):460-7.
PubMed 23265162Maroto M, Barberia E, Planells P, Garcia Godoy F. Dentin bridge formation after mineral trioxide aggregate (MTA) pulpotomies in primary teeth. Am J Dent. 2005 Jun;18(3):151-4.
PubMed 16158803
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Stability of NeoMTA Pulpotomized Primary Teeth
- ClinicalTrials.gov ID
- NCT03254290
- Acronym / sponsor ID
- TexasAMBaylor
- Conditions
- Dental Caries Extending to Pulp
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Texas A & M University Baylor College Of DentistryUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 18 Aug 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.
This randomized control study will use 15 pediatric subjects selected from the patient population in the pediatric dental clinic at Children's Medical Center Dental Clinic (CMC Dental Clinic). The study will use a within-subject control design whereby one tooth will be treated with a pulpotomy using the new formulation of MTA (NeoMTA Plus, Avalon Biomed Inc., Bradenton, FL, USA) and restored with a multi-surface composite, and the other tooth with a formocresol pulpotomy and restored with a multi-surface composite; thus, approximately 15 teeth will be treated for each treatment group. The specific treated tooth will be randomized as to which side will receive the MTA or formocresol using sealed, opaque envelopes. Approximately 15 subjects will be needed for the study in order to elicit any significant findings as demonstrated by a power analysis.
Detailed description
Each of the 15 patients will represent a pair of teeth. Within a given patient, assignment of the first tooth to either treatment will be determined randomly by selecting a sealed, opaque envelope with a designated treatment, with another tooth being assigned to the other treatment. All patients must demonstrate sufficient cooperation for treatment and follow-up radiographs. All procedures, possible risks or discomforts, in addition to possible benefits will be explained to the parents of all patients involved, and informed consent will be obtained from each parent.
The goal will consist of completing all treatment in one appointment; however, in the event that all treatment is unable to be completed, for example, local anesthetic limitations, the patient will be scheduled for the next available appointment, keeping them as close together as possible.
Patients will be anesthetized with local anesthesia, and treatment will be performed utilizing rubber dam isolation. The pulpotomy procedure will include removal of the carious tooth structure using a high-speed carbide bur and water spray. When the removal of carious tooth structure results in pulp exposure, the roof of the chamber will be removed. A high-speed handpiece and sterile spoon excavator will be used to remove the coronal pulp tissue. The amputation site will be cleaned and hemostasis obtained with a wet cotton pellet. The site will then be treated with either a slurry of NeoMTA Plus according to the manufacturer's directions or traditional Formocresol according to the manufacturer's directions. The remaining pulp chamber will be filled with a visible light cured resin-reinforced glass ionomer and will then receive a multi-surface composite final restoration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Children between the ages of 2 ½ and 9 years of age and be ASA I or ASA II. Patient must have two, primary teeth that are matched for, size of carious lesion (same level of approximation of carious lesion to the pulp) and are that are treatment planned for a pulpotomy. The teeth selected for the study must be vital and asymptomatic both clinically and radiographically or only display symptoms consistent with reversible pulptitis The teeth selected for the study must be anticipated to be retained in the mouth for at least eighteen months
| Arm | Type | Receives |
|---|---|---|
| Experimental NeoMTA | Experimental | Biological: NeoMTA, Biological: FormocresolThe new formulation of MTA (does not contain bismuth oxide) will be used in one tooth receiving a pulpotomy to determine if the color of the tooth changes over time.The new formulation has received the FDAs 510(k) substantial equivalence clearance for Class II dental materials and is equivalent to its MTA predicate (ProRoot, Dentsply Tulsa Dental, Tulsa, OK, USA). |
| Formocresol | Active comparator | Biological: FormocresolControl group. This group will receive the "gold standard" formulation of a formocresol pulpotomy. |
Who may qualify
- Ages
- 30 months to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between the ages of 2 ½ and 9 years of age and be ASA I or ASA II. Patient must have two, primary teeth that are matched for, size of carious lesion (same level of approximation of carious lesion to the pulp) and are that are treatment planned for a pulpotomy. The teeth selected for the study must be vital and asymptomatic both clinically and radiographically or only display symptoms consistent with reversible pulptitis The teeth selected for the study must be anticipated to be retained in the mouth for at least eighteen months
Key exclusion criteria (1 listed)
- Teeth with a history of spontaneous pain. Teeth with radiographic evidence of internal or external resorption, intraradicular or periapical bone loss, loss of lamina dura, or widening of the periodontal ligament space
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 |
|---|---|---|
| NeoMTAA new formulation of MTA was developed in which bismuth oxide was omitted. | Biological | Experimental NeoMTA |
| FormocresolControl group | Biological | Experimental NeoMTA, Formocresol |
Primary outcome
Color stability
Time frame: 3 month recall
color scale (0=white/still esthetic; 1=slightly gray; 2=medium gray color; 3=dark gray
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Results publication: PubMed 15344622Agamy HA, Bakry NS, Mounir MM, Avery DR. Comparison of mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth. Pediatr Dent. 2004 Jul-Aug;26(4):302-9.
- Results publication: PubMed 16161395Farsi N, Alamoudi N, Balto K, Mushayt A. Success of mineral trioxide aggregate in pulpotomized primary molars. J Clin Pediatr Dent. 2005 Summer;29(4):307-11. doi: 10.17796/jcpd.29.4.n80t77w625118k73.
- Results publication: PubMed 15926290Holan G, Eidelman E, Fuks AB. Long-term evaluation of pulpotomy in primary molars using mineral trioxide aggregate or formocresol. Pediatr Dent. 2005 Mar-Apr;27(2):129-36.
- Results publicationJabbarifar SE, Khademi D, Ghasemi D. Success rates of formocresol pulpotomy versus mineral trioxide aggregate in human primary molar tooth. J Res Med Sci 2004; 9(6)L 55-8.
- Results publication: PubMed 17138165Peng L, Ye L, Tan H, Zhou X. Evaluation of the formocresol versus mineral trioxide aggregate primary molar pulpotomy: a meta-analysis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Dec;102(6):e40-4. doi: 10.1016/j.tripleo.2006.05.017. Epub 2006 Sep 26.
- Results publication: PubMed 10969431Farooq NS, Coll JA, Kuwabara A, Shelton P. Success rates of formocresol pulpotomy and indirect pulp therapy in the treatment of deep dentinal caries in primary teeth. Pediatr Dent. 2000 Jul-Aug;22(4):278-86.
- Results publication: PubMed 16532888Guelmann M, Fair J, Bimstein E. Permanent versus temporary restorations after emergency pulpotomies in primary molars. Pediatr Dent. 2005 Nov-Dec;27(6):478-81.
- Results publication: PubMed 12064493Holan G, Fuks AB, Ketlz N. Success rate of formocresol pulpotomy in primary molars restored with stainless steel crown vs amalga. Pediatr Dent. 2002 May-Jun;24(3):212-6.
- Results publication: PubMed 12412965Seale NS. The use of stainless steel crowns. Pediatr Dent. 2002 Sep-Oct;24(5):501-5.
- Results publication: PubMed 18477438Caceda JH. The use of resin-based composite restorations in pulpotomized primary molars. J Dent Child (Chic). 2007 May-Aug;74(2):147-50.
- Results publication: PubMed 17073200Cehreli ZC, Cetinguc A, Cengiz SB, Altay AN. Clinical performance of pulpotomized primary molars restored with resin-based materials. 24-month results. Am J Dent. 2006 Oct;19(5):262-6.
- Results publication: PubMed 15871455Guelmann M, Bookmyer KL, Villalta P, Garcia-Godoy F. Microleakage of restorative techniques for pulpotomized primary molars. J Dent Child (Chic). 2004 Sep-Dec;71(3):209-11.
- Avalon Biomed Inc 2014Link provided by the sponsor.
- 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 Early Phase 1 study testing NeoMTA and Formocresol in people with Dental Caries Extending to Pulp, run by Texas A & M University Baylor College Of Dentistry.
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 1 inclusion and 1 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 Aug 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Color stability (time frame: 3 month recall). 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 NCT03254290, which also lists 19 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 18 Aug 2017.