Dental CariesNCT01641861
A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment
A study testing Papacarie® and Conventional method in people with Dental Caries and Secondary Dental Caries, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison to the conventional drilling method. Read more about this study
- Who is it for?
- Ages 7 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Secondary Dental Caries, Personal Satisfaction
- What is being tested?
- Papacarie® and Conventional method
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient inclusion criteria:
- Child is between 7-8 years of ages (at date of enrollment) with at least one active caries lesion in second primary molar tooth with distinct dentine involvement requiring restoration
- Child is in good general health and has no existing health condition that may interfere with treatment such as asthma, tuberculosis, rheumatic fever/ congenital heart diseases, jaundice, juvenile diabetes, haemophilia, thalassemia, leukemia, anemia , HIV , allergy to any drug, and epilepsy.
- Tooth inclusion criteria:
- Second primary molar tooth with one active caries lesion with distinct dentine involvement requiring restoration using the World Health Organization Criteria.
- Tooth with isolated occlusal caries and caries extended on further than two-third of the dentine layer, which can be restoration as a Class I restoration.
- Carious cavity must be large enough so that the hand instruments can be operated.
- Tooth is vital without pathological process assessed clinically and radiographically.
Who cannot join
- Patient exclusion criteria:
- Child whose parent does not give informed consent.
- Child who are unwilling to undergo the dental treatment.
- Child who has a known allergy to the ingredients contained in dental anesthesia, Papacarie® or glass-ionomer filling material.
- Tooth exclusion criteria:
- Having extensive dental caries which may require pulp treatment.
- Tooth with a pathological process of the dental tissue other than caries that could affect the treatment, such as tooth development disorders or adjacent soft tissue lesion.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Dentistry , Khon Kaen University
Muang, Changwat Khon Kaen, 40002
About this study
Official title: Study of Papacarie® for Caries Removal.
The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison to the conventional drilling method.
Read the detailed description
Dental caries in children continues to affect a significant portion of the world population, especially in developing countries. There are many techniques used for dental caries treatment. The conventional method is to remove caries and prepare the cavity using dental burs. Disadvantages of this method; however, include the patients' repulsion of drilling, and possible thermal changes on tooth surface that may have an effect on the dental pulp tissues. In addition, the drilling technique frequently requires local anesthesia injections and sometimes results in the removal of sound tooth tissues. To overcome these problems and preserve the healthy dental tissues, the chemo-mechanical caries removal method was developed. The advantage by chemomechanical caries removal include less traumatic, less need local anesthesia, reduced chance of dental pulp exposure. And also it could be benefit to medical compromised patients.
Papacarie® is a new chemo-mechanical technique for caries removal with few published research and case reports. A randomized controlled trial is therefore needed to determine the efficacy of its use in general population. The aims of this study are to evaluate the efficacy of a chemo-mechanical system (Papacarie®) for caries removal in comparison to the conventional drilling method.
- Being tested
- Papacarie®, Conventional method
- Keywords
- Chemo-mechanical caries removal, Papacarie®
- Medical subject headings
- Dental Caries, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papacarie®Device
Also called Chemo-mechanical removal of decays Agent
Papacarie® is chemo-mechanical method for caries removal
Conventional methodProcedure or surgery
caries removal by using rotary instrument.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Experimental | control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist. Receives: Procedure: Conventional method |
| Intervention arm | Experimental | Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument. Receives: Device: Papacarie® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Failure
The dental restorations were evaluated at 6, 12, 18 and 24 months after treatment. Evaluation criteria included the condition of the filling material and presence of secondary caries at the margin of the restorations. The restoration status was re-categorized as a binary outcome: Treatment failure (Yes/No).
Measured: two years
Secondary outcomes (4)
Incidence of Secondary Caries
The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries.
Measured: two years
Number of Participants With Complete Caries Removal
The efficacy of caries removal was evaluated by the visual and tactile criteria. The completeness of caries removal was judged on the basis of clinical criteria involving the inspection of the tooth surfaces using a good light source, dental mirror and explorer. A blunt explorer was used to detect surface roughness by gently stroking across the dentine surfaces and to evaluate the dentine hardness. Complete caries removal was achieved if as remove soft and infected dentine until felt hard and leathery consistency of the dentine surfaces. The tactile criteria include the smooth passage of the blunt explorer and absence of a catch or a "tug-back" sensation.
Measured: immediately after treatment
Levels of Pain and Discomfort
The participants were assessed for the levels of pain and discomfort using the facial visual analogue scale (VAS). The score was recorded in ruler scale from 0-100 millimeters, 0 = no pain and 100 = extreme pain) before treatment with the child sitting on the dental chair and after treatment (completion of carious tissue removal). The difference in the VAS scores before and after treatment was calculated and compared between the two comparison groups.
Measured: immediately after treatment
Time Use for Caries Removal
The time taken for the removal of carious dentine was recorded using a stopwatch. Recorded time unit is seconds.
Measured: Immediately while treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Kemporn Kitsahawong, Khon Kaen University
- Investigators
- Kemporn Kitsahawong, DDS., MSc., Principal investigator, Faculty of Dentistry, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641861
- Sponsor's protocol ID
- HE542161
- Other IDs
- D43TW007768
- Status last verified
- Dec 2015
- First submitted
- 9 Jul 2012
- Last updated
- 3 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kitsahawong K, Seminario AL, Pungchanchaikul P, Rattanacharoenthum A, Sutthiprapaporn P, Pitiphat W. Efficacy of chemo-mechanical caries removal: a 24-month randomized trial. Front Oral Health. 2024 Dec 3;5:1458530. doi: 10.3389/froh.2024.1458530. eCollection 2024.
PubMed 39697785
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Papacarie® for Caries Removal.
- ClinicalTrials.gov ID
- NCT01641861
- Acronym / sponsor ID
- HE542161
- Keywords
- Chemo-mechanical caries removal, Papacarie®
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Study start
- Aug 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Posted 3 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison to the conventional drilling method.
Detailed description
Dental caries in children continues to affect a significant portion of the world population, especially in developing countries. There are many techniques used for dental caries treatment. The conventional method is to remove caries and prepare the cavity using dental burs. Disadvantages of this method; however, include the patients' repulsion of drilling, and possible thermal changes on tooth surface that may have an effect on the dental pulp tissues. In addition, the drilling technique frequently requires local anesthesia injections and sometimes results in the removal of sound tooth tissues. To overcome these problems and preserve the healthy dental tissues, the chemo-mechanical caries removal method was developed. The advantage by chemomechanical caries removal include less traumatic, less need local anesthesia, reduced chance of dental pulp exposure. And also it could be benefit to medical compromised patients.
Papacarie® is a new chemo-mechanical technique for caries removal with few published research and case reports. A randomized controlled trial is therefore needed to determine the efficacy of its use in general population. The aims of this study are to evaluate the efficacy of a chemo-mechanical system (Papacarie®) for caries removal in comparison to the conventional drilling method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Experimental | Procedure: Conventional methodcontrol arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist. |
| Intervention arm | Experimental | Device: Papacarie®Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument. |
Who may qualify
- Ages
- 7 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Patient inclusion criteria:
- Child is between 7-8 years of ages (at date of enrollment) with at least one active caries lesion in second primary molar tooth with distinct dentine involvement requiring restoration
- Child is in good general health and has no existing health condition that may interfere with treatment such as asthma, tuberculosis, rheumatic fever/ congenital heart diseases, jaundice, juvenile diabetes, haemophilia, thalassemia, leukemia, anemia , HIV , allergy to any drug, and epilepsy.
- Tooth inclusion criteria:
- Second primary molar tooth with one active caries lesion with distinct dentine involvement requiring restoration using the World Health Organization Criteria.
Key exclusion criteria (7 listed)
- Patient exclusion criteria:
- Child whose parent does not give informed consent.
- Child who are unwilling to undergo the dental treatment.
- Child who has a known allergy to the ingredients contained in dental anesthesia, Papacarie® or glass-ionomer filling material.
- Tooth exclusion criteria:
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 |
|---|---|---|
| Papacarie®Also: Chemo-mechanical removal of decays AgentPapacarie® is chemo-mechanical method for caries removal | Device | Intervention arm |
| Conventional methodcaries removal by using rotary instrument. | Procedure or surgery | Control arm |
Primary outcome
Number of Participants With Treatment Failure
Time frame: two years
The dental restorations were evaluated at 6, 12, 18 and 24 months after treatment. Evaluation criteria included the condition of the filling material and presence of secondary caries at the margin of the restorations. The restoration status was re-categorized as a binary outcome: Treatment failure (Yes/No).
4 secondary outcomes
Incidence of Secondary Caries
Time frame: two years
Number of Participants With Complete Caries Removal
Time frame: immediately after treatment
Levels of Pain and Discomfort
Time frame: immediately after treatment
Time Use for Caries Removal
Time frame: Immediately while treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39697785Kitsahawong K, Seminario AL, Pungchanchaikul P, Rattanacharoenthum A, Sutthiprapaporn P, Pitiphat W. Efficacy of chemo-mechanical caries removal: a 24-month randomized trial. Front Oral Health. 2024 Dec 3;5:1458530. doi: 10.3389/froh.2024.1458530. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Kemporn Kitsahawong, DDS., MSc. principal investigator
Faculty of Dentistry, Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Papacarie® and Conventional method in people with Dental Caries and Secondary Dental Caries, run by Khon Kaen University at 1 site in Thailand.
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 7 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 3 Mar 2016. 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 Thailand. 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?
Yes. Results are posted in the registry (first posted 3 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment Failure (time frame: two years). 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 NCT01641861, which also lists 1 linked publication.
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 3 Mar 2016.