A Comparative Study of PapacarieĀ® and the Conventional Method for Dental Caries Treatment (NCT01641861) | Clinical Trial Compass
CompletedNot Applicable
A Comparative Study of PapacarieĀ® and the Conventional Method for Dental Caries Treatment
Thailand488 participantsStarted 2012-08
Plain-language summary
The purpose study are to evaluate the efficacy of PapacarieĀ® for caries removal in comparison to the conventional drilling method.
Who can participate
Age range7 Years ā 8 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, PapacarieĀ® 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 ā¦