Clinical studies/ Toxicology Tests / Animal Studies

Clinical studies conducted in KMCT Dental College, Calicut confirm the following:

1. : Treatment of dentine caries with D-Solv’ leaves a caries free surface in most of the cases. Most patient have high acceptance of the treatment of D-Solv.

2. : Patients were more comfortable, most of them felt no pain and were much more relaxed during treatment compared with drilling.

3. D-SOLV’ gel only softens carious dentine. D-Solv’ gel doesn’t affect the enamel and healthy dentine.

This study was conducted with Ethical Committee Compliance.

Details of Toxicity testing:

To ensure that D-Solv’ is 100% safe the following tests were also conducted.

1. Dermal irritation test:

The non- invasive chemomechanical two-component caries removal agent may come in contact with the skin during the clinical procedure and the dermal effect is therefore examined. A single cutaneous application of the sample is administered to 30 Sprague Dawley rats in the following manner as per an FDA approved procedure. An occlusive bandage is used for groups 1 and 3. Grading of erythema and oedma of test and control sites for all animals were monitored at 15min, 1 h, 2h, 4h and 7 days. Test Article- D-Solv’. Control: Carisolv Gel. 5 rats from both sex/group.

Inference: Material did not elicit any dermal irritation following application on skin./p>

Table 1: Dermal irritation test details

Group Group Designation Vol (ml per animal) Exposure time (min) Number of animals
Male Female
1 Control article 0.5 10 5 5
2 Test article 0.5 1 5 5
3 Test article 0.5 10 5 5

Amd: 1 Guinea-pigs: as per ISO 10993- 10. :

15 healthy adult guinea pigs from both sex/group

Period of application: 3 days a week for three weeks.

Observations: Appearance of challenge skin sites were monitored at 24h, 48h and 72 h after removal of dressings.

Inference: Test Material did not elicit any skin sensitization potential in guinea pigs.

For Buccal Mucosa' test as per ISO 10993- 10. : 20 guinea pigs were used. Test material was applied once to buccal mucosa of 20 male guinea pigs under anesthesia. The material was placed on a cotton pellet and placed in contact with left buccal mucosa for 1 minute in 10 guinea pigs and 10 minutes in another 10 guinea pigs. A plane cotton pellet was placed contra laterally as a control in each case. Macroscopic observation and histo pathological evaluation were carried out.

Observations: Macroscopic observation and histopathological evaluation showed mucosal layer was intact and no significant difference in tissue response between test and control.

The physiological saline extract of the caries removal agent and positive control will be aseptically injected intraperitoneally into respective mice. After 24 hrs all the animals will be sacrificed. About 3h before sacrificing colchicine will be administered. The bone marrow from the femur bones will be collected, centrifuged, treated with hypotonic solution and again centrifuged. The cell button obtained will be fixed with methanol: glacial acetic acid solution and recentrifuged. The cell button after fixation will be used for preparing smears by dropping on clean glass slides. The slides will be stained with Giemsa stain. The slides have to be subjected to microscopic evaluation for the evidence of chromosomal anomalies.

The physiological saline extract of the caries removal control material and positive control will be aseptically injected intraperitoneally into respective mice. After 24 hrs all the animals will be sacrificed. The bone marrow from the femur bones will be collected into fetal serum mixed thoroughly and centrifuged. The cell button will be used for preparing smears on clean glass slides. The slides will be stained using May-Grunwald and counter stained with Giemsa stain. The slides will be then subjected to microscopic evaluation for the evidence of polychromatic erythrocytes with micro nuclei, and normochromatic erythrocytes.

Details of In vivo tests carried out :

Name of test Standard used Animals used Material used Observation Inference: Result
Dermal Irritation study FDA approved procedure Sprague Dawley rats (5 Nos) Test : (D-Solv’ Gel) Grading of erythema and oedma monitored at 15min, 1h, 2h, 4h and 7 days. The material did not produce any dermal irritation following application on skin The material meets the requirement of the test Passed
Sprague Dawley rats Control (Carisolv Gel) Grading of erythema and oedma monitored at 15min, lh, 2h, 4h and 7 days. The material did not produce any dermal irritation following application on skin The material meets the requirement of the test Passed
Closed patch test for delayed hyper-sensitivity ISO 10993- 10:2002/Amd: 1:2006(E) Guinea pigs (15 Nos.) Test : (D-Solv’ Gel) Appearance of challenge skin sites were monitored. Test Material did not elicit any skin sensitization potential in guinea pigs The material meets the requirement of the test Passed
Guinea pigs Control Appearance of challenge skin sites were monitored The material meets the requirement of the test Passed
Buccal mucosal test Submitted protocol(Summary of safety and effectiveness) Guinea pigs (20Nos.) Test : (D-Solv’ Gel) Macroscopic observation and histopathological evaluation showed mucosal layer was intact and no significant difference in tissue response between test and control Test material meets the requirement Passed
Guinea pigs Control Mucosal layer was intact Material meets the requirement Passed
Genotoxicity test: In vivo mammalian erythrocyte micronucleus test ISO 10993- 3:2003/Amd:1: 2006(E) Albino mice 36 animals (D-Solv’ Gel) The result indicated that the average percentage of micronucleated polychromatic erythrocytes induced by rthe test material was comparable with negative control material and the test material can be considered as non mutagenic Material meets the requirement Passed
Genotoxicity test: In vivo mammalian bone marrow chromosomal aberration test ISO 10993-3:2003/Amd:1:2006 (E) Albino mice 36 animals (D-Solv’ Gel) The result indicated that the average percentage of chromosomal aberrations induced by the test material was comparable with negative control group and the test material can be considered as non mutagenic Material meets the requirement Passed


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