Dental CariesCMCR09NCT01811420
Chemomechanical Caries Removal Using Papain Gel
A study testing Chemomechanical Caries Removal and Conventional method in people with Dental Caries, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
To evaluate the efficacy of a papain-based gel in caries removal. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Chemomechanical Caries Removal and Conventional method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Mar 2011
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with active caries without pulpal involvement in two deciduous molar teeth participated in the trial.
- The caries were located on the occlusal surface.
Who cannot join
- Children with pathological process of the dental tissue, with pulpal involvement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chemomechanical Caries Removal Using a Papain-Based Gel: A Randomized Clinical Trial
To evaluate the efficacy of a papain-based gel in caries removal.
Read the detailed description
Twenty children with at least two carious molar teeth without pulpal involvement participated in this randomized clinical trial. A total of 40 teeth were randomly divided into two treatment groups: group A, papain-based gel; and group B, conventional technique. Data collection included the time required for caries removal, need for local anesthesia, degree of discomfort, changes in the number of viable bacteria, and clinical evaluation of glass ionomer-cement restorations 6-month post-treatment.
- Conditions
- Dental Caries
- Being tested
- Chemomechanical Caries Removal, Conventional method
- Keywords
- dental caries, caries removal, chemomechanical caries removal
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemomechanical Caries RemovalProcedure or surgery
Chemomechanical Caries Removal Using A Papain-Based Gel
Conventional methodProcedure or surgery
Dental caries removal using rotatory instrument
| Study group | Role | What they receive |
|---|---|---|
| CHEMOMECHANICAL CARIES REMOVAL | Experimental | Dental caries removal using papain based gel Receives: Procedure: Chemomechanical Caries Removal |
| conventional method | Active comparator | Dental caries removal using rotatory instrument Receives: Procedure: Conventional method |
What is being measured
The primary outcome is the main question the study is designed to answer.
restauration evaluation
the restauration will be assessed by clinical examination for detection the current caries
Measured: 18 months
Secondary outcomes (1)
discomfort or pain
The Faces Pain Scale was used to evaluate the need for local anesthesia during the procedure. The child was asked to choose a face matching the intensity of his or her pain experience during the procedure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Jansiski Motta, University of Nove de Julho
- Investigators
- Lara J Motta, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811420
- Sponsor's protocol ID
- cariesremoval09
- Acronym
- CMCR09
- Status last verified
- Mar 2013
- First submitted
- 6 Mar 2013
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Motta LJ, Bussadori SK, Campanelli AP, Silva AL, Alfaya TA, Godoy CH, Navarro MF. Efficacy of Papacarie((R)) in reduction of residual bacteria in deciduous teeth: a randomized, controlled clinical trial. Clinics (Sao Paulo). 2014;69(5):319-22. doi: 10.6061/clinics/2014(05)04.
PubMed 24838896Motta LJ, Bussadori SK, Campanelli AP, da Silva AL, Alfaya TA, de Godoy CH, Navarro MF. Pain during Removal of Carious Lesions in Children: A Randomized Controlled Clinical Trial. Int J Dent. 2013;2013:896381. doi: 10.1155/2013/896381. Epub 2013 Dec 4.
PubMed 24363672
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemomechanical Caries Removal Using a Papain-Based Gel: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01811420
- Acronym / sponsor ID
- CMCR09 / cariesremoval09
- Conditions
- Dental Caries
- Keywords
- dental caries, caries removal, chemomechanical caries removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 Mar 2013 (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.
To evaluate the efficacy of a papain-based gel in caries removal.
Detailed description
Twenty children with at least two carious molar teeth without pulpal involvement participated in this randomized clinical trial. A total of 40 teeth were randomly divided into two treatment groups: group A, papain-based gel; and group B, conventional technique. Data collection included the time required for caries removal, need for local anesthesia, degree of discomfort, changes in the number of viable bacteria, and clinical evaluation of glass ionomer-cement restorations 6-month post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHEMOMECHANICAL CARIES REMOVAL | Experimental | Procedure: Chemomechanical Caries RemovalDental caries removal using papain based gel |
| conventional method | Active comparator | Procedure: Conventional methodDental caries removal using rotatory instrument |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with active caries without pulpal involvement in two deciduous molar teeth participated in the trial.
- The caries were located on the occlusal surface.
Key exclusion criteria (1 listed)
- Children with pathological process of the dental tissue, with pulpal involvement
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 |
|---|---|---|
| Chemomechanical Caries RemovalChemomechanical Caries Removal Using A Papain-Based Gel | Procedure or surgery | CHEMOMECHANICAL CARIES REMOVAL |
| Conventional methodDental caries removal using rotatory instrument | Procedure or surgery | conventional method |
Primary outcome
restauration evaluation
Time frame: 18 months
the restauration will be assessed by clinical examination for detection the current caries
1 secondary outcome
discomfort or pain
Time frame: 6 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 14 Mar 2013.
- Derived from this study: PubMed 24838896Motta LJ, Bussadori SK, Campanelli AP, Silva AL, Alfaya TA, Godoy CH, Navarro MF. Efficacy of Papacarie((R)) in reduction of residual bacteria in deciduous teeth: a randomized, controlled clinical trial. Clinics (Sao Paulo). 2014;69(5):319-22. doi: 10.6061/clinics/2014(05)04.
- Derived from this study: PubMed 24363672Motta LJ, Bussadori SK, Campanelli AP, da Silva AL, Alfaya TA, de Godoy CH, Navarro MF. Pain during Removal of Carious Lesions in Children: A Randomized Controlled Clinical Trial. Int J Dent. 2013;2013:896381. doi: 10.1155/2013/896381. Epub 2013 Dec 4.
Related trials for Dental Caries
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
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.
Lara J Motta, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemomechanical Caries Removal and Conventional method in people with Dental Caries, run by University of Nove de Julho at 1 site 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 2 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: finished, as of the sponsor's last update on 14 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
restauration evaluation (time frame: 18 months). 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 NCT01811420, which also lists 2 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 14 Mar 2013; AzTrials last refreshed its copy on 31 Oct 2026.