Dental Caries
Conditions
Keywords
Chemo-mechanical caries removal, Papain-based agents, Minimum invasive dentistry, Conservative dentistry, Dental fear, Tooth Decay
Brief summary
• The evolution of conservative dentistry that adopts the preservation of tooth structure and affected dentin that can remineralize and save the pulp from exposure, in addition to pain and fear that companies' traditional caries removal methods had led to the development of chemomechanical caries removal materials (CMCR). The old generations of CMCR agents were NaOcl-based materials which have disadvantages such as odor taste, Unpleasant smell, high cost, Limited shelf life, and time consumption. • All of the reasons described led to a new generation of CMCR materials depending on Enzymes such as Papain. Brix3000 and Papacarie duo are Papain-based materials with promising effects in caries removal and fewer disadvantages. Selecti-solve is a dental gel whose active ingredient is papain enzyme, it removes dental caries without the need for anesthesia and is selective for the infected dentin layer only which avoids the unnecessary loss of dentin, enamel breaking, and pulp exposure. This study aims to evaluate the efficacy of Papain-based materials compared to old NAOcl-Based materials in reducing the disadvantages of CMCR agents.
Detailed description
In previous literature, there has not been any study that compared the whole group of chemo-mechanical caries removal materials with such a unique collection of Papain-based CMCR agents. Papain-based agents could be promising materials in the evolution of Atraumatic Restorative treatment (ART) and Chemomechanical Caries removal methods that support conservative dentistry and the conservation of tooth structure and pulp vitality. Brix3000 has EBE technology (Encapsulating Buffer Emulsion) that claims to elevate the efficiency of Papain Enzyme and permits the use of a higher concentration of Papain 3,000 U/mg in the whole material (10%). Papacarie Duo has a unique combination of the main component of Papain Enzyme 6,000 U/mg and a small percentage of chloramine t that claims to increase efficiency and reduce the side effect of chloramine-based CMCR materials. Selecti-solve is a new material that consists of Papain as the main product and has promising effects in chemo-mechanical caries removal methods.
Interventions
PROCEDURETraditional Escavation
Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. \- Group 6: 15 carious teeth will be excavated chemo-mechanically using Selecti-solve.
PROCEDUREExcavation with Sodium Hypochlorite Gel 2.5%.
Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using Sodium Hypochlorite Gel 2.5%.
PROCEDUREExcavation with Papacarie Duo
Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using a Papacarie Duo.
PROCEDUREExcavation with Brix3000
Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using a Brix3000.
PROCEDUREExcavation with Selecti-solve
Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using a Selecti-solve.
Sponsors
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Wide carious lesion (Class 1 Black) on Molars at the middle third of dentine confirmed with a periapical x-ray * No pulp involvement is assured with a periapical radiograph. * Good oral hygiene * Cooperated patient. * No oral diseases.
Exclusion criteria
* Pulp exposure or bleeding during excavation. * Pregnancy * Systematic diseases * Gingival and periodontal involvement. * Lack of patient cooperation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success in caries removal by a detecting dye | After procedure completion, which is expected to be within 20 minutes on average. | The efficacy of caries removal will be assessed by a sharp probe aided by Caries Detector dye. The Cavity will be inspected after every application by a sharp probe to feel any tacky sensation in dentin, when it is all hard dentin, caries detector dye will be applied to aid the investigation. Caries detector dye will be left for 10 seconds and then rinsed with water, it will stain the organic matrix of less mineralized dentin so the cavity should be stained homogeneously so high-intensity colored spots refer to infected dentin and it will be removed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time required for caries removal | After procedure completion, which is expected to be within 20 minutes on average. | Time from the beginning of the caries excavation to the end of the process will be recorded in minutes using a stopwatch. |
| Pain perception during caries removal | After procedure completion, which is expected to be within 20 minutes on average. | Visual analog scale (VAS) will be used to evaluate the pain perception during the procedure of caries removal. The patient will be asked to choose a number from 0 to 10 matching the intensity of his or her pain experience during the procedure. The higher the score, the more painful the procedure is. |
Countries
Syria
Outcome results
None listed