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

Primary Purpose

Dental Caries

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
BRIX3000
papacarie
hand excavation
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

8 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy children aged 8-10 years old. The presence of at least one deep carious class 1 lesion in the first permanent molar with a score of 5 or 6 according to the International Detection and Assessment System (ICDAS), detected by visual-tactile inspection to assess lesion severity Exclusion Criteria: Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling or abscess. Pulpal exposure or bleeding during the excavation procedure Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases affecting salivary flow. Allergy or sensitivity to any of the materials included in the study

Sites / Locations

  • Faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

BRIX 3000

Papacarie

Hand excavation

Arm Description

brix 3000 used

papacarie duo used

hand excavation used

Outcomes

Primary Outcome Measures

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
The clinical assessment will be at 3-, 6- and 12-month intervals to evaluate restoration success according to the criteria of atraumatic restorative treatment by Phantumvanit et al. (1996) .Restorations which will receive a score of 0, 1 or 7 will be considered successful while those having a score of 2, 3, 4 or 8 will be considered failures. Those which will receive a score of 5, 6 will be excluded from the analysis.
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
The radiographic evaluation will be performed using the radiographic subtraction method

Secondary Outcome Measures

the required time for complete caries removal for each method
The time needed for complete caries removal will be recorded for each caries removal method.
f patients' subjective pain reactions following each method
Subjective pain will be assessed after caries removal by means of WongBaker faces scale. It consists of faces with different facial expression for happiness and pain and is scored from 0-5 as 0 is very happy and feels no pain and 5 is very painful
antimicrobial effect of two chemo-mechanical caries removal agents
Samples from the carious lesion will be collected prior to and following complete caries removal for detection of the change in bacterial count (Streptococci and Lactobacilli counts).

Full Information

First Posted
June 9, 2023
Last Updated
August 7, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05983900
Brief Title
Clinical Evaluation and Antimicrobial Effect of Papain Based Chemo-mechanical Caries Removal Agents
Official Title
Clinical Evaluation and Antimicrobial Effect of Papain Based Chemo-mechanical Caries Removal Agents in Young Permanent Molars (A Randomized Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed Description
All the lesions in the children's oral cavity indicated for treatment will be treated and sampled for microbiological analysis prior to and following caries removal. On the day of the intervention, the children will be asked to refrain from tooth brushing in the morning, as well as eating and drinking (except water) for at least two hours before the appointment. The patients will be instructed to rinse with a cup of water, then the outer surface of the carious lesion will be washed with a flurry of water to avoid contamination of plaque bacteria. The tooth will then be partially isolated using cotton rolls and saliva ejector. Two portions of dentin will be collected with sterile excavators from the middle of the cavity to perform the microbiological analysis of each tooth before and then after caries removal procedure. The dentin sample will then be inserted in a sterile test tube containing 1 mL of saline and transported to the microbiology laboratory within 1-2 hours. The bacterial count obtained for a given amount of dentin will be used to estimate the number of colonies present in 1 mg dentin (CFU/mg). In the CMCR group: either Papacarie duo or Brix 3000 gel will be applied on the carious lesion of tooth and left undisturbed for 30-60 seconds, following manufacturer instructions This produces softening of carious dentin, which will be removed with a hand excavator. This step will be repeated 2-3 times until dentin demonstrates slight resistance with no tug-back sensation when tested with an exploratory probe while pressing an explorer into dentin, then the application of the chemo-mechanical agents will be stop The visual test for assessment of complete caries excavation will be based on non-turbid appearance of the CMCR agent used. In the ART group hand excavation will be performed to remove the carious tissue from the cavity by using a sterile sharp hand excavator. The cavity will be determined to be caries-free according to visual and tactile clinical criteria. No local anesthesia will be administered as it would alter the pain perception of the patient unless necessary.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BRIX 3000
Arm Type
Experimental
Arm Description
brix 3000 used
Arm Title
Papacarie
Arm Type
Active Comparator
Arm Description
papacarie duo used
Arm Title
Hand excavation
Arm Type
Active Comparator
Arm Description
hand excavation used
Intervention Type
Procedure
Intervention Name(s)
BRIX3000
Intervention Description
chemo-mechanical caries removal agent
Intervention Type
Procedure
Intervention Name(s)
papacarie
Intervention Description
chemo-mechanical caries removal agent
Intervention Type
Procedure
Intervention Name(s)
hand excavation
Intervention Description
mechanical caries removal
Primary Outcome Measure Information:
Title
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
Description
The clinical assessment will be at 3-, 6- and 12-month intervals to evaluate restoration success according to the criteria of atraumatic restorative treatment by Phantumvanit et al. (1996) .Restorations which will receive a score of 0, 1 or 7 will be considered successful while those having a score of 2, 3, 4 or 8 will be considered failures. Those which will receive a score of 5, 6 will be excluded from the analysis.
Time Frame
one year follow up
Title
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
Description
The radiographic evaluation will be performed using the radiographic subtraction method
Time Frame
one year follow up
Secondary Outcome Measure Information:
Title
the required time for complete caries removal for each method
Description
The time needed for complete caries removal will be recorded for each caries removal method.
Time Frame
immediately after the intervention
Title
f patients' subjective pain reactions following each method
Description
Subjective pain will be assessed after caries removal by means of WongBaker faces scale. It consists of faces with different facial expression for happiness and pain and is scored from 0-5 as 0 is very happy and feels no pain and 5 is very painful
Time Frame
immediately after the intervention
Title
antimicrobial effect of two chemo-mechanical caries removal agents
Description
Samples from the carious lesion will be collected prior to and following complete caries removal for detection of the change in bacterial count (Streptococci and Lactobacilli counts).
Time Frame
immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy children aged 8-10 years old. The presence of at least one deep carious class 1 lesion in the first permanent molar with a score of 5 or 6 according to the International Detection and Assessment System (ICDAS), detected by visual-tactile inspection to assess lesion severity Exclusion Criteria: Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling or abscess. Pulpal exposure or bleeding during the excavation procedure Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases affecting salivary flow. Allergy or sensitivity to any of the materials included in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Passant HM Hassanein, MSC
Phone
+201007749463
Email
passant.metwally@alexu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelwahab Samaha, PHD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalia A Talaat, PHD
Organizational Affiliation
Alexandria University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Passant HM Hassanein, MSC

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
study protocol will be availabe
IPD Sharing Time Frame
June 2023- June 2024
IPD Sharing Access Criteria
Researchers interested
IPD Sharing URL
http://clinicalTrials.gov

Learn more about this trial

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

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