Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06171594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-11-09
Brief Title:
The Effect of Chlorhexidine on the Oral Microbiome and Saliva in Dental Erosion
Sponsor:
University of Portsmouth
Organization:
University of Portsmouth
Study Overview
Official Title:
The Effect of Chlorhexidine on the Oral Microbiome Salivary Pellicle Proteins and Vascular Function in Individuals With Dental Erosion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dental erosion happens when the teeth lose some of their parts because of acid from the things people eat andor drink or even from stomach It can make teeth hurt and become sensitive The mouth has a protective shield called salivary pellicle that helps and there are some special bacteria called Nitrate-reducing bacteria NRB that can be good for the mouth and heart Eating some fruits and vegetables or drinking beetroot can make these bacteria thrive which might help the heart and blood pressure This study wants to see how administering chlorhexidine mouthwash affects the good bacteria in the mouth for people with healthy teeth and those with erosion This study aims to find out if this mouthwash can change the saliva and bacteria in the mouth for the better in people with both healthy teeth and those with dental erosion
The proposed study is part of a PhD educational project and will be a double blind randomised design crossover trial for the effect of Chlorhexidine CHX mouthwash on healthy control and people with dental erosion PwDE This study aims to explore mouthwashs effect on oral microbiome recovery in WMS and salivary pellicle and its impact on blood pressure and arterial stiffness in healthy controls PwDE
The proposed study is part of a PhD educational project and will be a double blind randomised design crossover trial for the effect of Chlorhexidine CHX mouthwash on healthy control and people with dental erosion PwDE This study aims to explore mouthwashs effect on oral microbiome recovery in WMS and salivary pellicle and its impact on blood pressure and arterial stiffness in healthy controls PwDE
Detailed Description:
Upon consent being granted several samples and measurements will be collected from the participant during this research study spanning over 15 visits The proposed study will be a double blind randomised design crossover trial for the effect of CHX mouthwash on healthy control and PwDE Two groups of participants are required for this study healthy n12 and PwDE n12 groups from volunteer participants from the university of Portsmouth UoP who have no signs of or reported medical problems detailed protocol of recruitment attached Based on power calculation 14 individuals will be recruited for each group healthy and PwDE groups to account for a 14 drop-out rate
Participants will be approached to volunteer for the study by the chief investigator and PhD researcher through word of mouth emails via departmental staff lists University of Portsmouth Dental Academy UPDA updates newsletter UPDA department meetings and presentations about the study during the UPDAs journal club event A participant information sheet PIS and consent form see attached forms will be distributed either via email or by handing out hard copies to those wishing to partake in the research Participants who have returned their completed consent form will be invited to come to UPDA for further assessment of suitability visit 1
The participants who has agreed to take part in this research will be invited to attend the University of Portsmouth Dental Academy Beatty Building UPDA for fifteen consecutive visits They will be invited to attend the UPDAs dental clinics for their first visit for clinical screening and baseline sampling then for their consecutive sampling visits 14 visits to attend Spinnaker Building School of Sport Health Exercise Science University of Portsmouth SbUoP for further sampling
Visit 1 30 minutes-1 hour This visit will include clinical screening consent and baseline samples taken and will take place at UPDA dental clinics The mouths of participants will be screened for suitability to fit in either of the groups healthy or dental erosion groups depending on the presence or absence of dental erosion in their teeth A BEWE will be used to screen as whether participants have erosion or not It is a simple reproducible and convenient scoring system that can be used for recording clinical findings of dental erosion If BEWE score is greater than 8 per extant cumulative score and one score 3 in at least one sextant then this means the participants mouth shows evidence of dental erosion If a participant is found to be suitable based upon inclusionexclusion criteria see attached detailed protocol they will be invited to attend further appointments
A medical history dental history and two further questionnaires Diet Questionnaire and Reflux Disease Questionnaire will be completed to ensure that they are suitable for this research study
After the oral assessment and completing all forms and questionnaires participants will be assigned to two groups of participants healthy n12 and dental erosion n12 groups Within each group the twelve participants will be randomly and blindly assigned to further two subgroups by an independent researcher to receive one of the mouthwash treatments placebo CHX group n6 and antibacterial CHX mouthwash group n6 as can be seen in the attached protocol In the same visit they will then be invited to come to the science laboratory Beatty Building UPDA for several sample collections As described in the protocol and participant information sheet these will include measuring participants blood pressure and brachial artery endothelium-dependent function Next venous blood will be collected via venepuncture from the forearm in 4 mL aliquots After that saliva and salivary pellicle from teeth and tongue will be collected
Then each participant from each subgroup will either receive 14 tubes containing 10 mL CHX placebo mouthwash ultrapure mint-flavoured water or another 14 tubes containing 10 ml antibacterial mouthwash containing 02 CHX Corsodyl Mint GlaxoSmithKline UK depending on the randomisation process Both versions of the mouthwash will be identical in taste appearance colour texture and smell using plain identical bottles for both solutions They will be instructed to administer each product in a reverse order which will thoroughly be explained by a member of our research team during this visit visit 1 Specifically participants will be instructed to rinse their mouth with the selected mouthwash for 1 minute twice a day for 7 days taking the final tube the morning before their next visit visit2 For study standardisation participants will also be given a standardised toothpaste to use throughout the duration of the study
Visit 2 - 8 30-40 minutes per visit
Seven days after visit 1 participants will be invited to return to the SbUoP for visit 2 between 9AM-12PM with the final dose being administered 2 hours prior to their scheduled appointment time Upon arrival blood pressure of the brachial artery forearm will be measured following 30 minutes of seated rest in a quiet room using an automated sphygmomanometer A total of five successive measurements will be taken with 1-minute rest between readings with the mean of the final three measurements to be recorded The mean of the systolic SBP diastolic DBP and mean arterial pressure MAP measurements will also be recorded Endothelial function test and brachial artery endothelium-dependent function will be measured as described below in the analysis section Next venous blood will be collected via venepuncture from the forearm in 4 mL aliquots as described in the analysis section Finally WMS AEP and tongue SP samples will then be collected as described in the detailed sample collection section below
All participants will then be invited to come to the SbUoP for further six visits in which same samples and measurements will be collected
Upon completion of final sample collections visit 8 each participant from each group healthy control n6 and PwDEn6 will receive the reverse order of the product they had received in visit 1 cross over to be used after a washout period of 12-weeks Each participant will either receive 14 tubes containing 10 mL CHX placebo mouthwash ultrapure mint-flavoured water or another 14 tubes containing 10 ml antibacterial mouthwash containing 02 CHX Corsodyl Mint GlaxoSmithKline UK in the reverse order crossover design depending on what they have had before the washout period visit1 as seen in figure1
Washout and Reverse treatment
After visit 8 participants will be instructed to carry out a washout period of 12-weeks before starting the 7-day reverse order of the given product administration as above Specifically the 6 participants from each group healthy n12 and PwDE n12 who had administered placebo CHX mouthwash before visit 2 will be given same amount of antibacterial mouthwash containing 02 CHX Corsodyl Mint GlaxoSmithKline UK to be administered in the same conditions as explained above 1 min twice daily for 7 days with the final tube taken the morning before their next visit visit 9 The other 6 individuals will be instructed to administer the placebo CHX in the reverse order crossover of their 5 counterparts during visit 2 as shown in figure 1 twice daily with the final tube to be taken the morning before visit 9
Visit 9 - 15 30-40 minutes per visit
Visit 9 will take place after the 12-week washout period followed by seven days of administering the reverse product as seen in figure 1 Participants will be invited to return to the SbUoP between 9AM-12PM with the final dose being taken 2 hours prior to their scheduled appointment time visit 9 Upon arrival same sample and measurements will be repeated as visits 2-8 Upon completion of final sample collections visit 15 this will be the end of volunteer participation
Participants will be approached to volunteer for the study by the chief investigator and PhD researcher through word of mouth emails via departmental staff lists University of Portsmouth Dental Academy UPDA updates newsletter UPDA department meetings and presentations about the study during the UPDAs journal club event A participant information sheet PIS and consent form see attached forms will be distributed either via email or by handing out hard copies to those wishing to partake in the research Participants who have returned their completed consent form will be invited to come to UPDA for further assessment of suitability visit 1
The participants who has agreed to take part in this research will be invited to attend the University of Portsmouth Dental Academy Beatty Building UPDA for fifteen consecutive visits They will be invited to attend the UPDAs dental clinics for their first visit for clinical screening and baseline sampling then for their consecutive sampling visits 14 visits to attend Spinnaker Building School of Sport Health Exercise Science University of Portsmouth SbUoP for further sampling
Visit 1 30 minutes-1 hour This visit will include clinical screening consent and baseline samples taken and will take place at UPDA dental clinics The mouths of participants will be screened for suitability to fit in either of the groups healthy or dental erosion groups depending on the presence or absence of dental erosion in their teeth A BEWE will be used to screen as whether participants have erosion or not It is a simple reproducible and convenient scoring system that can be used for recording clinical findings of dental erosion If BEWE score is greater than 8 per extant cumulative score and one score 3 in at least one sextant then this means the participants mouth shows evidence of dental erosion If a participant is found to be suitable based upon inclusionexclusion criteria see attached detailed protocol they will be invited to attend further appointments
A medical history dental history and two further questionnaires Diet Questionnaire and Reflux Disease Questionnaire will be completed to ensure that they are suitable for this research study
After the oral assessment and completing all forms and questionnaires participants will be assigned to two groups of participants healthy n12 and dental erosion n12 groups Within each group the twelve participants will be randomly and blindly assigned to further two subgroups by an independent researcher to receive one of the mouthwash treatments placebo CHX group n6 and antibacterial CHX mouthwash group n6 as can be seen in the attached protocol In the same visit they will then be invited to come to the science laboratory Beatty Building UPDA for several sample collections As described in the protocol and participant information sheet these will include measuring participants blood pressure and brachial artery endothelium-dependent function Next venous blood will be collected via venepuncture from the forearm in 4 mL aliquots After that saliva and salivary pellicle from teeth and tongue will be collected
Then each participant from each subgroup will either receive 14 tubes containing 10 mL CHX placebo mouthwash ultrapure mint-flavoured water or another 14 tubes containing 10 ml antibacterial mouthwash containing 02 CHX Corsodyl Mint GlaxoSmithKline UK depending on the randomisation process Both versions of the mouthwash will be identical in taste appearance colour texture and smell using plain identical bottles for both solutions They will be instructed to administer each product in a reverse order which will thoroughly be explained by a member of our research team during this visit visit 1 Specifically participants will be instructed to rinse their mouth with the selected mouthwash for 1 minute twice a day for 7 days taking the final tube the morning before their next visit visit2 For study standardisation participants will also be given a standardised toothpaste to use throughout the duration of the study
Visit 2 - 8 30-40 minutes per visit
Seven days after visit 1 participants will be invited to return to the SbUoP for visit 2 between 9AM-12PM with the final dose being administered 2 hours prior to their scheduled appointment time Upon arrival blood pressure of the brachial artery forearm will be measured following 30 minutes of seated rest in a quiet room using an automated sphygmomanometer A total of five successive measurements will be taken with 1-minute rest between readings with the mean of the final three measurements to be recorded The mean of the systolic SBP diastolic DBP and mean arterial pressure MAP measurements will also be recorded Endothelial function test and brachial artery endothelium-dependent function will be measured as described below in the analysis section Next venous blood will be collected via venepuncture from the forearm in 4 mL aliquots as described in the analysis section Finally WMS AEP and tongue SP samples will then be collected as described in the detailed sample collection section below
All participants will then be invited to come to the SbUoP for further six visits in which same samples and measurements will be collected
Upon completion of final sample collections visit 8 each participant from each group healthy control n6 and PwDEn6 will receive the reverse order of the product they had received in visit 1 cross over to be used after a washout period of 12-weeks Each participant will either receive 14 tubes containing 10 mL CHX placebo mouthwash ultrapure mint-flavoured water or another 14 tubes containing 10 ml antibacterial mouthwash containing 02 CHX Corsodyl Mint GlaxoSmithKline UK in the reverse order crossover design depending on what they have had before the washout period visit1 as seen in figure1
Washout and Reverse treatment
After visit 8 participants will be instructed to carry out a washout period of 12-weeks before starting the 7-day reverse order of the given product administration as above Specifically the 6 participants from each group healthy n12 and PwDE n12 who had administered placebo CHX mouthwash before visit 2 will be given same amount of antibacterial mouthwash containing 02 CHX Corsodyl Mint GlaxoSmithKline UK to be administered in the same conditions as explained above 1 min twice daily for 7 days with the final tube taken the morning before their next visit visit 9 The other 6 individuals will be instructed to administer the placebo CHX in the reverse order crossover of their 5 counterparts during visit 2 as shown in figure 1 twice daily with the final tube to be taken the morning before visit 9
Visit 9 - 15 30-40 minutes per visit
Visit 9 will take place after the 12-week washout period followed by seven days of administering the reverse product as seen in figure 1 Participants will be invited to return to the SbUoP between 9AM-12PM with the final dose being taken 2 hours prior to their scheduled appointment time visit 9 Upon arrival same sample and measurements will be repeated as visits 2-8 Upon completion of final sample collections visit 15 this will be the end of volunteer participation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None