Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05427591 |
Other study ID # |
Manal Maashi |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 1, 2019 |
Est. completion date |
January 1, 2021 |
Study information
Verified date |
June 2022 |
Source |
King Abdulaziz University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Dental caries is one of the most prevalent chronic diseases in people worldwide. Traditional
clinical treatment of dental decay has developed on the basis of the removal of carious
tissues with high-speed handpieces and slow-rotating instruments, inducing pain, disturbing
sounds, and vibrations. In addition, this method comprises the tooth structure by removing
both "caries-affected dentin" and "caries-infected dentin". The use of the chemo-mechanical
caries removal (CMCR) method is one of the main implementations of the minimal intervention
dentistry idea accepted in the last ten years. It includes the selective removal of
"caries-infected dentin" while preserving the healthy "caries-affected dentin" that has the
ability to remineralize. The CMCR method differs from the traditional surgical method in that
it selectively removes carious dentin. Therefore, it is less destructive and less painful,
thereby promoting a positive attitude towards visiting dentists. A novel agent for the CMCR
method named "BRIX3000®" by the laboratory Brix Medical Science has been released onto the
dental market in 2016. It is a papain-based gel derived from latex and fruits of green papaya
(Carica Papaya) that works as a chemical debridement with a unique technology called
Encapsulating Buffer Emulsion (EPE). Investigations are required to evaluate and compare the
outcomes of two CMCR agents, "BRIX3000®" and "Carie-CareTM," versus the traditional surgical
methods. Therefore, the present study aims to perform a clinical and microbiological
evaluation of caries removal using "BRIX3000®" and "Carie-CareTM" versus the traditional
surgical methods in primary molars among children in Jeddah city, Saudi Arabia.
Description:
Dental caries is one of the most prevalent chronic diseases in people worldwide. It results
in localized dissolution and destruction of the calcified tooth tissues. The destruction of
the dental structure does not occur as a result of a localized accumulation of bacteria, but
rather as a result of an invasive and infectious process caused by the interaction of several
interconnected factors. These factors make dental caries a great challenge for the dentist,
as they seek an efficient means to control it. Carious dentin consists of two distinct
layers: an outer "caries-infected dentin" and an inner "caries-affected". The
"caries-affected" dentin is described as demineralized inter-tubular dentin, crystal
deposition in dentinal tubules, and a lesser amount of destructed collagen matrix with no
bacterial invasion. On the contrary, the "caries-infected" dentin displays deformation of the
microstructure of the dentinal tubules and permanently damaged collagen fibers with
significant penetration of the bacteria. Thus, the "caries-infected" dentin has to be removed
only during caries removal. Traditional clinical treatment of dental decay has developed on
the basis of the removal of carious tissues with high-speed handpieces and slow-rotating
instruments, inducing pain, disturbing sounds, and vibrations. In addition, this method
comprises the tooth structure by removing both "caries-affected dentin" and "caries-infected
dentin". The concept of minimal intervention dentistry (e.g., air abrasion, laser,
chemo-mechanical caries removal (CMCR) agents) includes the selective removal of
caries-infected dentin while preserving the healthy caries-affected dentin that has the
ability to remineralize. It is less destructive and less painful, thereby promoting a
positive attitude towards visiting dentists among children. Brix Medical Science in 2016
released a new CMCR agent named "BRIX3000®". It is an enzymatic gel for non-traumatic caries
removal known with exclusive technology as "Encapsulating Buffer Emulsion" (EPE) that is
claimed to have superior characteristics for caries removal compared to previous products
available in the dental market. There are a few studies present in the literature, most of
them published in non-English language versions, evaluating the clinical and laboratory
properties of "BRIX3000®". Therefore, investigations were required to evaluate and compare
the outcomes of "BRIX3000®" versus the previous CMCR agent, "Carie-CareTM" and the
traditional surgical methods. This study was carried out at King Abdulaziz Dental University
Hospital (KADUH) and the Microbiology Research Laboratory in the Faculty of Pharmacy, King
Abdulaziz University, Jeddah, Saudi Arabia to evaluate the efficacy, efficiency, and pain
experienced by children with the use of the CMCR agents "BRIX3000®" and "Carie-CareTM" versus
the traditional surgical method in primary molars. The study was approved by the "Research
Ethics committee" at the Faculty of Dentistry, King Abdulaziz University (KAU) under approval
number 107-06-19. Informed written consent will be signed by the parents/guardians of the
children after explaining it to them. The study sample will be consisted of healthy and
cooperative children aged 4 to 9 years old with bilateral open occlusal carious lesions in
primary molars who will be seen as outpatients at KADUH's Department of Pediatric Dentistry
from October 2019 to December 2020.The sample size was measured using G power analysis for
calculating an estimated sample size. The final sample will be consisted of 60 children aged
4-9 years with 30 pairs of matched contralateral open occlusal carious lesions in primary
molars meeting the inclusion criteria. They will be randomly allocated to either group (1) or
group (2). In group 1, 30 children with 60 primary molars will be subjected to caries removal
by the CMCR method "BRIX3000®" (the experimental group) on one molar (n = 30) and the
traditional surgical method (the control group) on the contralateral molar (n = 30). In group
2, 30 children with 60 primary molars will be subjected to caries removal by the CMCR method
"Carie-CareTM" (the experimental group) on one molar (n = 30) and the traditional surgical
method (the control group) on the contralateral molar (n = 30). The block randomization
method (a block of the two contralateral teeth) will be used to make sure that each side was
treated evenly by both methods. The statistical assessment will be carried out using the
Statistical Package for Social Sciences (SPSS, V.20, IBM, NY, USA). A significance level of
5% was utilized for all analyses.