Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511336
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Alkaline Water and Salivary Bacterial Count
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Alkaline Water Effect on Salivary Streptococcus Mutans in Children
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be aimed to examine the effect of alkaline water on salivary streptococcus mutans bacteria which is the main cause of dental caries and comparing its effect with chlorohexidine mouthwash on the children aged 10-12 tap water will be used as mouthwash for negative control group
Detailed Description:
Oral health has a major influence on ones general and oral health-related quality of life and well-being Dental caries is characterized by demineralization of calcified tissues of the teeth due to several factors Approximately 60-65 of children in India are affected by dental caries Several organisms are involved in the development of carious lesions However the literature strongly reports Streptococcus mutans S mutans as the potential organism involved in the initiation of dental caries This is because S mutans can attach to the enamel surface produce acid metabolites provide glycogen reserves and can synthesize extracellular polysaccharides
Several antimicrobial agents with varying efficacy have been reported for the reduction of dental caries Preventive programs such as the use of fluoride toothpaste community water fluoridation and mouth rinses focusing primarily on the reduction of caries have also been carried out to reduce the prevalence of the disease These substances inhibit the adhesion of bacteria their colonization and metabolic activity ultimately affecting their growth Presently bisbiguanide being the most efficacious chemotherapeutic agent against S mutans has high bactericidal activity against both gram-positive and gram-negative bacteria But it has a few side effects such as tooth discoloration the altered sensation of taste and erosion of oral mucosa Also due to the developing antimicrobial resistance to the currently available antibiotics and chemotherapeutics the implementation of alternative treatment options for oral diseases that are safer effective and economical are needed
Among various natural alternatives which have been studied alkaline water has gained great interest in dentistry alkaline water can be a safer and cheaper alternative to chemical adjuncts The use of mouthwash is quite widespread by the public because the mouthwash is sold freely in stores supermarkets or supermarkets the public only knows the effects of mouthwash to prevent bad breath alone without knowing the side effects when using for a long time Based on the problem the researcher is interested to know whether the alkaline solution has a function like the function of mouthwash that can inhibit streptococcus mutans Materials and Methods this double-blinded randomized control clinical study will be carried out at Pedodontic clinics in Pharos University A total of 30 schoolchildren will be selected by convenience sampling method Inclusion criteria involved children between 10 and 12 years of age without any systemic disorder or presence of gingivitis-calculus
Exclusion criteria involved children who were already using mouthwashes history of oral prophylaxis within 6 months and had fixed or removable orthodontic appliances or removable prostheses Written informed consent will be obtained from parents of all selected children The children will be randomly divided into 3 groups by computer-generated random sequence Group A - alkaline water group Group B - 02 CHX mouthwash group and Group C - Tap water group The bottles will be coded along with the written instructions to use before dispensing to the children The coding was will be done by a person who was not involved in the study so that the double blinding design of the study was maintained The children will be provided with 140 ml of their respective mouthwashes for home use every week The children and examiner will be blind to allocation ie the type of mouthwash All the selected children were demonstrated a correct method of using mouthwash according to the group that they were assigned to Children were instructed to use 10 ml of mouthwash as prescribed ie take 10 ml of the mouth rinse in the measuring cap rinse for 30 s and spit out twice daily for 21 days under the parents supervision A printed timetable for 3 weeks will be given to the parents and they were asked to put a checkmark on the form after rinsing to check the compliance of the instructions given The bacterial count will be evaluated at baseline week 1 week 2 and week 3
Statistical analysis
Data will be tabulated and analyzed using SPSS software version 25
Several antimicrobial agents with varying efficacy have been reported for the reduction of dental caries Preventive programs such as the use of fluoride toothpaste community water fluoridation and mouth rinses focusing primarily on the reduction of caries have also been carried out to reduce the prevalence of the disease These substances inhibit the adhesion of bacteria their colonization and metabolic activity ultimately affecting their growth Presently bisbiguanide being the most efficacious chemotherapeutic agent against S mutans has high bactericidal activity against both gram-positive and gram-negative bacteria But it has a few side effects such as tooth discoloration the altered sensation of taste and erosion of oral mucosa Also due to the developing antimicrobial resistance to the currently available antibiotics and chemotherapeutics the implementation of alternative treatment options for oral diseases that are safer effective and economical are needed
Among various natural alternatives which have been studied alkaline water has gained great interest in dentistry alkaline water can be a safer and cheaper alternative to chemical adjuncts The use of mouthwash is quite widespread by the public because the mouthwash is sold freely in stores supermarkets or supermarkets the public only knows the effects of mouthwash to prevent bad breath alone without knowing the side effects when using for a long time Based on the problem the researcher is interested to know whether the alkaline solution has a function like the function of mouthwash that can inhibit streptococcus mutans Materials and Methods this double-blinded randomized control clinical study will be carried out at Pedodontic clinics in Pharos University A total of 30 schoolchildren will be selected by convenience sampling method Inclusion criteria involved children between 10 and 12 years of age without any systemic disorder or presence of gingivitis-calculus
Exclusion criteria involved children who were already using mouthwashes history of oral prophylaxis within 6 months and had fixed or removable orthodontic appliances or removable prostheses Written informed consent will be obtained from parents of all selected children The children will be randomly divided into 3 groups by computer-generated random sequence Group A - alkaline water group Group B - 02 CHX mouthwash group and Group C - Tap water group The bottles will be coded along with the written instructions to use before dispensing to the children The coding was will be done by a person who was not involved in the study so that the double blinding design of the study was maintained The children will be provided with 140 ml of their respective mouthwashes for home use every week The children and examiner will be blind to allocation ie the type of mouthwash All the selected children were demonstrated a correct method of using mouthwash according to the group that they were assigned to Children were instructed to use 10 ml of mouthwash as prescribed ie take 10 ml of the mouth rinse in the measuring cap rinse for 30 s and spit out twice daily for 21 days under the parents supervision A printed timetable for 3 weeks will be given to the parents and they were asked to put a checkmark on the form after rinsing to check the compliance of the instructions given The bacterial count will be evaluated at baseline week 1 week 2 and week 3
Statistical analysis
Data will be tabulated and analyzed using SPSS software version 25
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None