Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562699
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
Buffering Capacity of Matcha Green Tea on Salivary PH After an Acidic Attack
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Buffering Capacity of Matcha Green Tea at Two Different Temperatures on Salivary PH After an Acidic Attack A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
ph
Brief Summary:
This study is conducted to evaluate the buffering capacity of hot matcha brew in comparison with cold matcha brew and water on salivary pH after an acidic attack using a digital pH meter
Research Question
Will matcha green tea beverage have similar salivary buffering effect as water after an acidic challenge on dental interns Steps in short
1 Recruitment of the patients and clinical examination with medical and dental history taking
2 Informed consent taking for the eligible participants to participate in the study
3 A volume of 2 mL saliva samples will be collected before the commencement of acidic attack baseline T0
4 After the acidic attack saliva will be collected again by spitting method and their pH value will be measured T1
5 After 5 minutes of the acidic attack participants will be instructed to swish either hot matcha tea cold matcha tea or water then swallow and saliva samples will be collected T2
6 Then saliva will be collected after 10 T3 20 T4 30 T5 and 40 T6 minutes
Research Question
Will matcha green tea beverage have similar salivary buffering effect as water after an acidic challenge on dental interns Steps in short
1 Recruitment of the patients and clinical examination with medical and dental history taking
2 Informed consent taking for the eligible participants to participate in the study
3 A volume of 2 mL saliva samples will be collected before the commencement of acidic attack baseline T0
4 After the acidic attack saliva will be collected again by spitting method and their pH value will be measured T1
5 After 5 minutes of the acidic attack participants will be instructed to swish either hot matcha tea cold matcha tea or water then swallow and saliva samples will be collected T2
6 Then saliva will be collected after 10 T3 20 T4 30 T5 and 40 T6 minutes
Detailed Description:
The investigators aim to study the effect of matcha green tea on salivary pH to enhance the volume of scientific awareness and research attention in this area
Interventions
Examination
For every participant medical and dental history caries risk assessment profile and salivary flow test will be obtained
Clinical examination will be done by mouth mirror explorer and compressed air through triple syringe to check for active oral diseases
Trial procedure
The participants will be instructed not to brush their teeth in the morning on the day samples will be taken and not to eat or drink until the beginning of the trial to minimize possible food debris and stimulation of saliva
The trial time for collecting participants saliva will be carried out at 0900-1100 UTC2 to prevent any bias in the concentration of saliva due to circadian rhythm
Before the beginning of the trial the pH value of saliva of all participants will be determined A volume of 2 mL saliva samples will be collected before the commencement of acidic attack baseline T0
Saliva samples will be collected using spitting method by pooling saliva for 60 s and then spitting in a disposable container sitting in an upright position in a well-lit room with good ventilation The participants will drool the saliva sample in a 15 mL plastic sterile test tube with lid to prevent CO2 loss to the atmosphere The salivary sample of each participant will be collected in separate test tubes coded with specific identity number and pH of each sample noted
The pH value will be measured with a digital pH meter AD1030 Adwa Instruments Hungary Calibration of the pH meter will be performed before measuring The glass electrode will be immersed in the saliva sample and after each measurement it will be carefully cleaned with deionized water and dried with filter paper The salivary pH value will be determined by 3 consecutive immersions of the pH meter glass electrode in the test tube with the sample and the mean value will be taken as the obtained value
After the initial salivary pH determination each participant will be given 25 ml of soft drink V7 Cola at room temperature Participants will be asked to rinse their mouth using 25 ml V7 Cola 34 times and then swallow Participants will be asked to consume it within 5 minutes of baseline pH
Then saliva will be collected again by spitting method and their pH value will be measured T1
Intervention
Hot matcha brew will be prepared in usucha thin consistency version-2 grams of matcha powder DrBaby mixed with 30 mL of hot water 75 C The first step will be to massage the matcha powder with a small amount of water until a smooth paste forms then additional 50 mL of hot water will be added to dilute down the concentration The matcha will then be vigorously shaken in a lidded jar
After 5 minutes of the acidic attack participants will be instructed to swish 25 mL of matcha tea 34 times then swallow and saliva samples will be collected T2
Then saliva will be collected after 10 T3 20 T4 30 T5 and 40 T6 minutes
Comparators
First comparator 25 mL of cold matcha brew prepared in usucha thin consistency version-2 grams of matcha powder DrBaby mixed with 80 mL of cold water 13 C swished 34 times then swallowed
Second comparator Water elano at 13 C swished 34 times then swallowed
Outcomes Outcomes will be assessed by a digital pH meter AD1030 Adwa Instruments Hungary
Sample size In a previous study by Dehghan et al in 2015 the salivary pH within water group after acidic challenge after 45 minutes was normally distributed with standard deviation 056 If the true difference between Matcha green tea and water beverages is 05 by using moderate cohens d effect size the investigators will need to study 21 patients per group to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability power 08 The Type I error probability associated with this test of this null hypothesis is 005 Sample size was calculated using PS Power and Sample for windows version 316 using independent t test
Recruitment Dental interns of New Giza University Egypt will be recruited for an open-label parallel group randomized controlled clinical trial The selection will be made by the method of random choice The first 63 interns who register for the offered sessions and meet the criteria for inclusion in the research will be selected as subjects
Assignment of interventions
Allocation
Sequence generation HS will perform simple randomization according to a check list including the number of participants by generating numbers from 1 to 63 divided into three groups denoting with letters A B and C Randomization will be generated using wwwrandomizationcom
Allocation concealment mechanism The allocation sequence will be kept with HS in sealed tight envelopes concealed from the principal investigator AA and the outcome assessor EM The principal investigator AA will know the allocation of the consented participant just before starting the trial procedure
Implementation All participants who fulfill eligibility criteria and who give consent for participation will be randomized by HS into three groups
Blinding masking
Outcome assessors will be blinded to the intervention assigned as well as statisticians Participants cannot be blinded due to the distinctive taste color and temperature of different intervention beverages
Data collection management and analysis Data collection methods For every participant medical and dental history and caries risk assessment profile will be obtained The examination chart will be filled in by AA AA will record telephone numbers and addresses of all subjects in the study as a part of the signed consent
Data management All paper sheets are concerned with the personal or outcome data will be stored in a locked cabinet and in the computer at the Conservative Department The excel sheets of the patients data will be stored in the computer of the Conservative Department School of Dentistry New Giza University The computer will have a password known only to AA and HS to prevent unauthorized access to data and double data entry
Statistical methods Data will be analyzed using Medcalc software version 22 for windows MedCalc Software Ltd Ostend Belgium Continuous data will be described using mean and standard deviation Intergroup comparison between continuous variables will be performed using independent t test and intragroup comparison will be done using repeated measures ANOVA followed by tukeys post hoc test A p-value less than or equal to 005 will be considered statistically significant and all tests will be two tailed Statistical power of the study will be set at 80 with 95 confidence level
Monitoring Data monitoring OM and HS will monitor this study will have full access to the results and will take the final decision to terminate the trial
Harms AA should inform participants about possible harms unpleasant tastes uncomfortable spitting process If present participants should inform the principal investigator and the data will be reported to the main supervisor HS Harms will be managed through water intake and trial termination
Auditing In this trial auditing will be done by the main and co-supervisors OM and HS to assure the quality of the research methods and interventions
Interventions
Examination
For every participant medical and dental history caries risk assessment profile and salivary flow test will be obtained
Clinical examination will be done by mouth mirror explorer and compressed air through triple syringe to check for active oral diseases
Trial procedure
The participants will be instructed not to brush their teeth in the morning on the day samples will be taken and not to eat or drink until the beginning of the trial to minimize possible food debris and stimulation of saliva
The trial time for collecting participants saliva will be carried out at 0900-1100 UTC2 to prevent any bias in the concentration of saliva due to circadian rhythm
Before the beginning of the trial the pH value of saliva of all participants will be determined A volume of 2 mL saliva samples will be collected before the commencement of acidic attack baseline T0
Saliva samples will be collected using spitting method by pooling saliva for 60 s and then spitting in a disposable container sitting in an upright position in a well-lit room with good ventilation The participants will drool the saliva sample in a 15 mL plastic sterile test tube with lid to prevent CO2 loss to the atmosphere The salivary sample of each participant will be collected in separate test tubes coded with specific identity number and pH of each sample noted
The pH value will be measured with a digital pH meter AD1030 Adwa Instruments Hungary Calibration of the pH meter will be performed before measuring The glass electrode will be immersed in the saliva sample and after each measurement it will be carefully cleaned with deionized water and dried with filter paper The salivary pH value will be determined by 3 consecutive immersions of the pH meter glass electrode in the test tube with the sample and the mean value will be taken as the obtained value
After the initial salivary pH determination each participant will be given 25 ml of soft drink V7 Cola at room temperature Participants will be asked to rinse their mouth using 25 ml V7 Cola 34 times and then swallow Participants will be asked to consume it within 5 minutes of baseline pH
Then saliva will be collected again by spitting method and their pH value will be measured T1
Intervention
Hot matcha brew will be prepared in usucha thin consistency version-2 grams of matcha powder DrBaby mixed with 30 mL of hot water 75 C The first step will be to massage the matcha powder with a small amount of water until a smooth paste forms then additional 50 mL of hot water will be added to dilute down the concentration The matcha will then be vigorously shaken in a lidded jar
After 5 minutes of the acidic attack participants will be instructed to swish 25 mL of matcha tea 34 times then swallow and saliva samples will be collected T2
Then saliva will be collected after 10 T3 20 T4 30 T5 and 40 T6 minutes
Comparators
First comparator 25 mL of cold matcha brew prepared in usucha thin consistency version-2 grams of matcha powder DrBaby mixed with 80 mL of cold water 13 C swished 34 times then swallowed
Second comparator Water elano at 13 C swished 34 times then swallowed
Outcomes Outcomes will be assessed by a digital pH meter AD1030 Adwa Instruments Hungary
Sample size In a previous study by Dehghan et al in 2015 the salivary pH within water group after acidic challenge after 45 minutes was normally distributed with standard deviation 056 If the true difference between Matcha green tea and water beverages is 05 by using moderate cohens d effect size the investigators will need to study 21 patients per group to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability power 08 The Type I error probability associated with this test of this null hypothesis is 005 Sample size was calculated using PS Power and Sample for windows version 316 using independent t test
Recruitment Dental interns of New Giza University Egypt will be recruited for an open-label parallel group randomized controlled clinical trial The selection will be made by the method of random choice The first 63 interns who register for the offered sessions and meet the criteria for inclusion in the research will be selected as subjects
Assignment of interventions
Allocation
Sequence generation HS will perform simple randomization according to a check list including the number of participants by generating numbers from 1 to 63 divided into three groups denoting with letters A B and C Randomization will be generated using wwwrandomizationcom
Allocation concealment mechanism The allocation sequence will be kept with HS in sealed tight envelopes concealed from the principal investigator AA and the outcome assessor EM The principal investigator AA will know the allocation of the consented participant just before starting the trial procedure
Implementation All participants who fulfill eligibility criteria and who give consent for participation will be randomized by HS into three groups
Blinding masking
Outcome assessors will be blinded to the intervention assigned as well as statisticians Participants cannot be blinded due to the distinctive taste color and temperature of different intervention beverages
Data collection management and analysis Data collection methods For every participant medical and dental history and caries risk assessment profile will be obtained The examination chart will be filled in by AA AA will record telephone numbers and addresses of all subjects in the study as a part of the signed consent
Data management All paper sheets are concerned with the personal or outcome data will be stored in a locked cabinet and in the computer at the Conservative Department The excel sheets of the patients data will be stored in the computer of the Conservative Department School of Dentistry New Giza University The computer will have a password known only to AA and HS to prevent unauthorized access to data and double data entry
Statistical methods Data will be analyzed using Medcalc software version 22 for windows MedCalc Software Ltd Ostend Belgium Continuous data will be described using mean and standard deviation Intergroup comparison between continuous variables will be performed using independent t test and intragroup comparison will be done using repeated measures ANOVA followed by tukeys post hoc test A p-value less than or equal to 005 will be considered statistically significant and all tests will be two tailed Statistical power of the study will be set at 80 with 95 confidence level
Monitoring Data monitoring OM and HS will monitor this study will have full access to the results and will take the final decision to terminate the trial
Harms AA should inform participants about possible harms unpleasant tastes uncomfortable spitting process If present participants should inform the principal investigator and the data will be reported to the main supervisor HS Harms will be managed through water intake and trial termination
Auditing In this trial auditing will be done by the main and co-supervisors OM and HS to assure the quality of the research methods and interventions
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