Clinical Evaluation and Antimicrobial Effect of Papain Based Chemo-mechanical Caries Removal Agents - Trial NCT05983900

Timeline & Enrollment

Primary Outcome

To assess and compare the efficacy of two chemo-mechanical agents Brix 3000 and Papacarie duo in terms of their clinical success in young permanent molars, in comparison with hand excavation approach,To assess and compare the efficacy of two chemo-mechanical agents Brix 3000 and Papacarie duo in terms of their radiographic success in young permanent molars, in comparison with hand excavation approach

Summary

Minimally invasive dentistry continues to gain importance, especially in the treatment of
 permanent teeth with deep caries lesions and immature roots. Chemo-mechanical caries removal
 (CMCR) is an alternative to the conventional method and consists of the application of a
 proteolytic substance that softens carious dentin tissue and facilitates its removal using
 manual instruments. This method can be employed without the use of local anesthesia or burs,
 thereby preserving sound dental tissue.
 
 The trial aim to assess the clinical performance of Brix 3ooo and Papacarie duo gel as
 chemo-mechanical caries removal agents (CMCR), their performance in terms of time required
 for the caries removal, patient subjective pain reaction, their radiographic success and
 their antimicrobial effect in comparison with Atraumatic Restorative Treatment (ART) hand
 excavation method for caries removal.
 
 The trial will include 108 children with age ranging between 8 and 10 years old who have at
 least one carious first permanent molar will be randomly divided into three groups. A
 three-arm randomized clinical trial where test groups, group I, caries removal will be using
 Brix 3000, and group II Papacarie duo will be used, while the control group hand excavation
 will be the method of caries removal. Dentin samples of three groups will be taken prior to
 and following caries removal. The total viable streptococci and lactobacilli count will be
 determined and expressed as colony forming units per milliliter (CFU). The time required for
 caries removal with each method will be calculated and the subjective pain reaction following
 each method will be recorded. After complete caries removal step, it will be followed by
 restoration with glass ionomer restoration. Patients will be followed up at 3-, 6- and
 12-month intervals to determine the clinical success and at 6- and 12- month intervals for
 the radiographic success rate for each caries removal method.

ICD-10 Classifications