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N/A Completed N=488 Randomized Single-blind Treatment

A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment

Dental Caries · Secondary Dental Caries · Personal Satisfaction
Source: ClinicalTrials.gov NCT01641861 ↗
Enrolled (actual)
488
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Number of Participants With Treatment Failure — 2; 2 participants

Summary

The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison to the conventional drilling method.

Outcome Measures

OutcomeResultp-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

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.
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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