A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment
Study of Papacarie® for Caries Removal.
2 other identifiers
interventional
488
1 country
1
Brief Summary
The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison to the conventional drilling method.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
March 3, 2016
CompletedMarch 3, 2016
December 1, 2015
3.1 years
July 9, 2012
December 6, 2015
February 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
two years
Secondary Outcomes (4)
Incidence of Secondary Caries
two years
Number of Participants With Complete Caries Removal
immediately after treatment
Levels of Pain and Discomfort
immediately after treatment
Time Use for Caries Removal
Immediately while treatment
Study Arms (2)
Control arm
EXPERIMENTALcontrol 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
EXPERIMENTALIntervention 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.
Interventions
Papacarie® is chemo-mechanical method for caries removal
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry , Khon Kaen University
Muang, Changwat Khon Kaen, 40002, Thailand
Related Publications (1)
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.
PMID: 39697785DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The limitations: First, the long duration of the trial caused participants to lost to follow up. Second, the operator and patients could not be blinded from the treatment status because of the apparent difference in the intervention techniques.
Results Point of Contact
- Title
- Dr. Kemporn Kitsahawong
- Organization
- Khon Kaen University
Study Officials
- PRINCIPAL INVESTIGATOR
Kemporn Kitsahawong, DDS., MSc.
Faculty of Dentistry, Khon Kaen University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
July 9, 2012
First Posted
July 17, 2012
Study Start
August 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
March 3, 2016
Results First Posted
March 3, 2016
Record last verified: 2015-12
Data Sharing
- IPD Sharing
- Will not share