Sodium hydrogencarbonate

Direct observations: clinical cases, poisoning incidents and other

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

Test material information

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.