PulpotomyNCT03200938
Clinical Applicability of PBS® CIMMO Cement in Pulpotomies
A study testing formocresol and zinc oxide. and PBS CIMMO cement. in people with Pulpotomy, run by Universidade do Vale do Sapucai at 2 sites in Brazil.
Trial summary
Randomized clinical study in pulpotomies of deciduous molar teeth. A comparison of two techniques is established. Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy
- What is being tested?
- formocresol and zinc oxide. and PBS CIMMO cement.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesBrazil
- Study dates
- Oct 2016to Oct 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 3 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Teeth exhibiting caries exposure
- Teeth with incomplete rhizogenesis
- Absence of periradicular lesion and fistula
- Accidental pulp exposure
Who cannot join
- Teeth with spontaneous pain
- Teeth With impossibility to perform absolute isolation
- Teeth with mobility, presence of fistula and root resorption of more than two-thirds of the root
- Teeth unable to be restored
- Teeth with painful response after vertical percussion
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Fernanda Valadão Moysés
Pouso Alegre, Minas Gerais, 37550000
Univás
Pouso Alegre, Minas Gerais, 37550000
About this study
Official title: Clinical Applicability of PBS® CIMMO Cement in Decoded Teeth Pulpotomies as Base and Restoration
Randomized clinical study in pulpotomies of deciduous molar teeth. A comparison of two techniques is established.
Read the detailed description
This is a randomized controlled clinical trial conducted at the Universidade do Vale do Sapucaí (UNIVAS), Pouso Alegre, Minas Gerais and the University of Vale do Rio Verde (UNINCOR) Três Corações, Minas Gerais. A project will be submitted to the Brazil Platform to UNIVÁS and UNINCOR ethics committees. Thirty children aged four to ten years old will be selected from the Pediatric Dentistry Clinic of the College of Dentistry of the Vale do Rio Verde Três Corações University. The sample will consist of 30 primary molars that show indication for pulpotomy. The inclusion criteria of the teeth to be selected are: absence of spontaneous painful symptomatology in the preoperative period, evidence of live red bleeding, cut resistance, associated with hemostasis after exposure of the pulp tissue. Radiographically, the teeth should present 2/3 of the root length, absence of radiolucent inter-radicular lesion and internal root resorption.
The technique recommended will be in a single session. Local anesthesia with 1: 100,000 articaine (DFL®) will be used a tube containing 1.8 ml. Absolute insulation with clamp 14 (IVORY®), rubber sheet (Madeitex®) and arch (JON®). The opening will be performed with a 1016 HL (KG®) drill and a dentin curette (Duflex®). All carious tissue and the coronary pulp will be removed with abundant irrigation.
In group A (control) the irrigation will be with physiological saline and then it will be applied in the pulp chamber with autoclaved cotton ball, formocresol for five minutes. Subsequently, calcium hydroxide cement base (Hidro C®), zinc oxide cement base and eugenol (IRM®) and restoration of the final tooth with composite resin will be inserted.
In group B the irrigation will be with sterile distilled water (the cement to be used loses its properties in front of the saline solution). Excess blood and distilled water from the irrigation will be sucked through disposable endodontic cannula (DFL®) and the fast trapped PBS®CIMMO cement will be handled through sterile glass plate and spatula 24 (Duflex®). Then it will be taken to the humid chamber with cement door, old amalgam (Duflex®) and condenser with Schilder condenser number 5 (Odus®). The cement will serve as a sub-base, base and final restoration.
Patients will be submitted to final radiographs and receive systemic medication with analgesic and anti-inflammatory. The evaluations will be carried out in 6 months and will be through clinical and radiographic examinations, to define the result of the treatments. Clinical examinations will be performed under artificial light through an exploratory probe (Duflex®) and clinical mirror (Duflex®). The clinical criteria to be observed are: edema, mobility, fistula and pain. The radiographic evaluations will be through periapical radiography with the aid of a radial ortho positioner (DFL®). In the radiographs will be observed the presence or absence of internal and external resorptions, as well as presence or absence of inter-radicular lesion.
The statistical analysis will be through the chi-square test and the level of significance will be 5%.
- Conditions
- Pulpotomy
- Being tested
- formocresol and zinc oxide., PBS CIMMO cement.
- Keywords
- pulpotomy, Biological cement, Deciduous tooth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
formocresol and zinc oxide.Device
Also called Formocresol and zinc oxide technique
Removal of the coronary pulp from primary molar teeth, use of formocresol and zinc oxide
PBS CIMMO cement.Device
Also called PBS CIMMO technique
Removal of the coronary pulp from primary molar teeth, use of PBS cement
| Study group | Role | What they receive |
|---|---|---|
| PBS CIMMO | Experimental | Intervention: PBS CIMMO cement Receives: Device: PBS CIMMO cement. |
| Zinc oxide | Active comparator | Intervention: Formocresol and zinc oxide Receives: Device: formocresol and zinc oxide. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical examination evaluate the repair capacity of PBS® CIMMO and Zinc Oxide cements in pulpotomies will be evaluated.
The restorative capacity of the PBS CIMMO and Zinc Oxide cements will be assessed by clinical and radiographic examination six months after the pulpotomies.
Measured: 12 months
Secondary outcomes (1)
Radiografhic examination evaluate the repair capacity of PBS CIMMO and Zinc Oxide
The restorative capacity of CIMMO PBS and Zinc Oxide cements will be assessed by radiographic examination six months after pulpotomies.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study startOct 2016
- Primary completion28 Aug 2017
- Study completionOct 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
- Model description
- Comparative study with same series for the two groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Dias da Silva Neto, Universidade do Vale do Sapucai
- Investigators
- José Neto, Principal investigator, teacher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200938
- Sponsor's protocol ID
- 57617816.9.0000.5102
- Status last verified
- Dec 2020
- First submitted
- 3 May 2017
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applicability of PBS® CIMMO Cement in Decoded Teeth Pulpotomies as Base and Restoration
- ClinicalTrials.gov ID
- NCT03200938
- Acronym / sponsor ID
- 57617816.9.0000.5102
- Conditions
- Pulpotomy
- Keywords
- pulpotomy, Biological cement, Deciduous tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 27 Jun 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.
Randomized clinical study in pulpotomies of deciduous molar teeth. A comparison of two techniques is established.
Detailed description
This is a randomized controlled clinical trial conducted at the Universidade do Vale do Sapucaí (UNIVAS), Pouso Alegre, Minas Gerais and the University of Vale do Rio Verde (UNINCOR) Três Corações, Minas Gerais. A project will be submitted to the Brazil Platform to UNIVÁS and UNINCOR ethics committees. Thirty children aged four to ten years old will be selected from the Pediatric Dentistry Clinic of the College of Dentistry of the Vale do Rio Verde Três Corações University. The sample will consist of 30 primary molars that show indication for pulpotomy. The inclusion criteria of the teeth to be selected are: absence of spontaneous painful symptomatology in the preoperative period, evidence of live red bleeding, cut resistance, associated with hemostasis after exposure of the pulp tissue. Radiographically, the teeth should present 2/3 of the root length, absence of radiolucent inter-radicular lesion and internal root resorption.
The technique recommended will be in a single session. Local anesthesia with 1: 100,000 articaine (DFL®) will be used a tube containing 1.8 ml. Absolute insulation with clamp 14 (IVORY®), rubber sheet (Madeitex®) and arch (JON®). The opening will be performed with a 1016 HL (KG®) drill and a dentin curette (Duflex®). All carious tissue and the coronary pulp will be removed with abundant irrigation.
In group A (control) the irrigation will be with physiological saline and then it will be applied in the pulp chamber with autoclaved cotton ball, formocresol for five minutes. Subsequently, calcium hydroxide cement base (Hidro C®), zinc oxide cement base and eugenol (IRM®) and restoration of the final tooth with composite resin will be inserted.
In group B the irrigation will be with sterile distilled water (the cement to be used loses its properties in front of the saline solution). Excess blood and distilled water from the irrigation will be sucked through disposable endodontic cannula (DFL®) and the fast trapped PBS®CIMMO cement will be handled through sterile glass plate and spatula 24 (Duflex®). Then it will be taken to the humid chamber with cement door, old amalgam (Duflex®) and condenser with Schilder condenser number 5 (Odus®). The cement will serve as a sub-base, base and final restoration.
Patients will be submitted to final radiographs and receive systemic medication with analgesic and anti-inflammatory. The evaluations will be carried out in 6 months and will be through clinical and radiographic examinations, to define the result of the treatments. Clinical examinations will be performed under artificial light through an exploratory probe (Duflex®) and clinical mirror (Duflex®). The clinical criteria to be observed are: edema, mobility, fistula and pain. The radiographic evaluations will be through periapical radiography with the aid of a radial ortho positioner (DFL®). In the radiographs will be observed the presence or absence of internal and external resorptions, as well as presence or absence of inter-radicular lesion.
The statistical analysis will be through the chi-square test and the level of significance will be 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparative study with same series for the two groups
| Arm | Type | Receives |
|---|---|---|
| PBS CIMMO | Experimental | Device: PBS CIMMO cement.Intervention: PBS CIMMO cement |
| Zinc oxide | Active comparator | Device: formocresol and zinc oxide.Intervention: Formocresol and zinc oxide |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Teeth exhibiting caries exposure
- Teeth with incomplete rhizogenesis
- Absence of periradicular lesion and fistula
- Accidental pulp exposure
Key exclusion criteria (5 listed)
- Teeth with spontaneous pain
- Teeth With impossibility to perform absolute isolation
- Teeth with mobility, presence of fistula and root resorption of more than two-thirds of the root
- Teeth unable to be restored
- Teeth with painful response after vertical percussion
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 |
|---|---|---|
| formocresol and zinc oxide.Also: Formocresol and zinc oxide techniqueRemoval of the coronary pulp from primary molar teeth, use of formocresol and zinc oxide | Device | Zinc oxide |
| PBS CIMMO cement.Also: PBS CIMMO techniqueRemoval of the coronary pulp from primary molar teeth, use of PBS cement | Device | PBS CIMMO |
Primary outcome
Clinical examination evaluate the repair capacity of PBS® CIMMO and Zinc Oxide cements in pulpotomies will be evaluated.
Time frame: 12 months
The restorative capacity of the PBS CIMMO and Zinc Oxide cements will be assessed by clinical and radiographic examination six months after the pulpotomies.
1 secondary outcome
Radiografhic examination evaluate the repair capacity of PBS CIMMO and Zinc Oxide
Time frame: 12 months
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 31 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Pulpotomy
Recruiting
Short Term Comparative Assessment of MTA and Biodentine in Complete Pulpotomy for Symptomatic Irreversible Pulpitis
Symptomatic Irreversible Pulpitis (SIP)
Not yet recruiting
Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
Recruiting
Pomegranate Peel Extract for Primary Molar Pulpotomy
Pulpitis Reversible, Pulp Exposure, Dental
Not yet recruiting
Evaluation of Pulpotomy Techniques (Formocresol, Ferric Sulphate, Mineral Trioxide Aggregate)
Periapical Healing
Active, not recruiting
Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
Molar Incisor Hypomineralisation, Irreversible Pulpitis
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.
José Neto principal investigator
teacher
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing formocresol and zinc oxide. and PBS CIMMO cement. in people with Pulpotomy, run by Universidade do Vale do Sapucai at 2 sites in Brazil.
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 5 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 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical examination evaluate the repair capacity of PBS® CIMMO and Zinc Oxide cements in pulpotomies will be evaluated. (time frame: 12 months). 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 31 Dec 2020.