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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
The effect of sodium bicarbonate oral rinse on salivary pH and oral microflora: A prospective cohor study
Author:
Chandel
Year:
2017
Bibliographic source:
National Journal of Maxillofacial Surgery, 2017, Vol. 8, Issue 2, p. 106-109

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
other: salivary pH and oral microflora
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Healthy subjects were asked to use a solution of sodium bicarbonate as oral rinse. Salivary samples were collected the following morning. The pH of the samples was determined and an aerobic bacterial culture of the samples was examined.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
sodium hydrogencarbonate
Cas Number:
144-55-8
IUPAC Name:
sodium hydrogencarbonate
Details on test material:
No details on test material available.
Specific details on test material used for the study:
No details available on test material.

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 25
- Sex: Not specified.
- Age: Not specified.
- Patient selection criteria: Only healthy controls were included in the study. Patients suffering from any systemic disease, undergoing radiotherapy, chemotherapy or using any systemic or topical medication were excluded from the study. Patients using tobacco, alcohol, or any other drugs in any form were excluded from the study.
Ethical approval:
not specified
Route of exposure:
other: oral rinse
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
Sodium bicarbonate solution was prepared by mixing approximately 3g of sodium bicarbonate powder in 50 mL of water, which was premeasured and marked on plastic glasses. Patients were instructed to avoid brushing in the night, and patients were further instructed to collect saliva with the help of sterile cotton swab. Subsequent morning they were instructed to rinse with the freshly prepared sodium bicarbonate solution. Participants were requested to collect the postrinse saliva samples with the help of sterile cotton gauge.
Examinations:
The pH of the saliva samples was measured with pH strips.
Aerobic bacterical culture was done by plating the sample directly from the swab on the surface of following culture medias. Blood agar was incubated at 37°C in 5% CO2 (candle jar) for 24h. Mac Conkey agar was incubated at 37°C for 24h in ambient air. Reading was obtained after 24h by counting of the colonies.

Results and discussion

Results of examinations:
The use of sodium carbonate as an oral rinsing solution increased the salivary pH significantly. The increase is statistically significant and sufficient in restricting enamel demineralization.
The number of CFU/mL of salive also decreased for bacteria, espescially viridans streptococci, Moraxella spps, but this decrease was not statistically significant.

Any other information on results incl. tables

 

Pre-rinse

pH

Pre-rinse

culture (x10E4)

Post-rinse

pH

Post-rinse culture (x10E4)

n

25

25

25

25

Mean

7.208

43.11

9.360

10.25

SD

0.4949

76.981

0.6658

10.721

 

Applicant's summary and conclusion

Conclusions:
The salivary pH increased significantly after the use of a sodium bicarbonate oral rinse. There was a marginal decrease in number of CFU/ml for bacteria especially Viridans Streptococci, Moraxella species.

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