N/A
N=488
A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment
Dental Caries · Secondary Dental Caries · Personal Satisfaction
Bottom Line
View on ClinicalTrials.gov: NCT01641861 ↗Enrolled (actual)
488
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Number of Participants With Treatment Failure — 2; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Papacarie® (Device); Conventional method (Procedure)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Khon Kaen University
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Failure |
2; 2 | — |
| SECONDARY Incidence of Secondary Caries |
3; 10 | — |
| SECONDARY Number of Participants With Complete Caries Removal |
246; 242 | — |
| SECONDARY Levels of Pain and Discomfort |
25; 10 | 0.001 sig |
| SECONDARY Time Use for Caries Removal |
103; 512 | 0.001 sig |
Summary
The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison to the conventional drilling method.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01641861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.