Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04756557
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2021-02-11
Brief Title:
Caries-preventing Effect of a Hydroxyapatite-toothpaste in Adults
Sponsor:
Poznan University of Medical Sciences
Organization:
Poznan University of Medical Sciences
Study Overview
Official Title:
Caries-preventing Effect of a Hydroxyapatite-toothpaste in Adults
Status:
COMPLETED
Status Verified Date:
2023-01
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:
CA1
Brief Summary:
Target question is as the following one
Does the daily use of a fluoride-free microcrystalline hydroxyap-atite HAP - containing test toothpaste have a non-inferior caries preventing effect in the permanent dentition compared to the regular use of a fluoride control toothpaste 1450 ppm F- with proven caries preventive efficacy Walsh et al 2019 This multicenter non-inferiority clinical trial randomized double-blind active-controlled design two-armed study evaluates the hypothesis that the home regular use of a toothpaste containing microcrystalline hydroxylapatite HAP test toothpaste provides a caries preventive effect in adults aged 18-45 comparable to the caries preventive effect provided by the regular use of a fluoridated tooth paste 1450 ppm -F control toothpaste over observation periods of max 18 months Caries development will be assessed according to the clinical criteria of the Decay Missing Filling Surface Index DMFS
Does the daily use of a fluoride-free microcrystalline hydroxyap-atite HAP - containing test toothpaste have a non-inferior caries preventing effect in the permanent dentition compared to the regular use of a fluoride control toothpaste 1450 ppm F- with proven caries preventive efficacy Walsh et al 2019 This multicenter non-inferiority clinical trial randomized double-blind active-controlled design two-armed study evaluates the hypothesis that the home regular use of a toothpaste containing microcrystalline hydroxylapatite HAP test toothpaste provides a caries preventive effect in adults aged 18-45 comparable to the caries preventive effect provided by the regular use of a fluoridated tooth paste 1450 ppm -F control toothpaste over observation periods of max 18 months Caries development will be assessed according to the clinical criteria of the Decay Missing Filling Surface Index DMFS
Detailed Description:
Caries-preventing effects of hydroxyapatite toothpastes have been shown in vivo children and adolescents Schlagenhauf et al 2019 Paszynska et al 2021 in situ Amaechi et al 2019 and in vitro Tschoppe et al 2011 However to date the caries-preventing effect of a hydroxyapatite toothpaste in adults without orthodontic treatment has not been investigated in a clinical trial compared to fluoride toothpastes
The aim of this clinical trial is to assess in cohorts of adults whether 2 x daily tooth brushing at home over an observation period of 18 months with a fluoride-free microcrystalline hydroxyapatite HAP - containing test toothpaste has a non-inferior caries preventing effect in the permanent dentition compared to the regular use of a fluoride control toothpaste 1450 ppm F- with proven caries preventive efficacy Walsh et al 2019 The study is designed as a multicentre two armed non-inferiority trial and will be performed by 2 study centres in Poland Caries development will be assessed by the Decay Missing Filling Surface Index DMFS
There are planned 4 visits for all subjects included to the project Description of the 4 visits is presented below
Visit 1 Screening and Baseline Study day 0 informed consent screening collection of baseline data and study inclusion Subjects potentially suitable for the study will be informed by the investigator about the nature sig-nificance and scope of the clinical trial according to the requirements described in the written subject information
Before study inclusion the willingness of the subjects to properly follow the study protocol during the complete treatment period of 546 days must be assessed Only when subjects have given their written informed consent heshe will be included as study participant
Subjects have to meet all inclusion criteria and no exclusion criteria Unsuitable subjects with un-treated caries in need of a restoration can become eligible after restorative therapy
Once informed consent has been given an initial examination will take place that covers the follow-ing aspects
Screening subjects for study eligibility inclusion and exclusion criteria
Demographic data Assessment of the study parameters has to be done on all teeth in the following sequence
Plaque control record PCR
Professional tooth cleaning
DMFS
DIAGNOcam After the analysis of the plaque control record using a plaque-staining solution see O Leary T Drake R Naylor 1972 a professional tooth cleaning will be performed Thereafter no fluoride gelvarnish etc will be applied
Finally the study subjects receive an electric toothbrush with 3 brushing heads replacement of the brushing head every 2 months and the allocated toothpaste test or control by a trained study nurse or dentist not involved in clinical study examinations
Proper use of the assigned electric toothbrush and the issued toothpaste is also instructed by this study nurse or a dentist not involved in the clinical study examinations
Visit 2 Study day 182 28 days at most 1st follow-up examination 182 days after baseline visit the following parameters are reassessed
Plaque control record PCR
Caries status DMFS as described for the baseline visit Subsequently a study nurse or a dentist not involved in clinical study examinations will hand out 3 new brushing heads for the electric toothbrush and a new supply of the assigned experimental toothpaste test or control for the next 182 days
Furthermore the study nurse will subsequently check the efficacy of the oral hygiene efforts of the subjects and if PCR will be 15 will train again with the subjects an efficacious brushing tech-nique Finally subjects receive a new appointment for visit 3
Visit 3 Study day 364 28 days at most 2nd follow-up examination 364 days after baseline visit the following parameters are reassessed
Plaque control record PCR
DMFS as described for the baseline visit Subsequently a study nurse or a dentist not involved in the clinical study examinations will hand out 3 new brushing heads for the electric toothbrush and a new supply of the assigned experimental toothpaste test or control for the next 182 days
Furthermore the study nurse will subsequently check the efficacy of the oral hygiene efforts of the subjects and if PCR will be 15 will train again with the subjects an efficacious brushing tech-nique Finally subjects receive a new appointment for visit 4
Visit 4 Study day 546 28 days at most final visit 546 days after baseline visit the following assessments are repeated
Plaque control record PCR
Professional tooth cleaning
DMFS
DIAGNOcam as described for the baseline visit
Methods of Determining Efficacy and Safety Methods of Determining Efficacy DMFS-index and PCR-scores will be determined by clinical examinations of the oral cavity In addi-tion analysis of mineral density using DIAGNOcam will be conducted according to the instructions of the manufacturer
Assessments of all clinical findings will be performed only by experienced dentists
DMFS Index Calculation The DMFS Index Decayed Missed Filled Surfaces is one of the most common methods in oral epidemiology for assessing dental caries prevalence as well as dental treatment needs among populations
DMFS Index calculation There are five surfaces on the posterior teeth facial lingual mesial distal and occlusal There are four surfaces on anterior teeth facial lingual mesial and distal The third molars are not counted
When a carious lesion or both a carious lesion and a restoration are present the surface is listed as a D
When a tooth has been extracted due to caries it is listed as an M
When a permanent filling is present or when a filling is defective but not decayed this surface is counted as an F Surfaces restored for reasons other than caries are not counted as an F
The total count is 128 surfaces
DIAGNOcam KaVo Dental DIAGNOcam will be used according to the instructions of the manufacturer The following classifi-cation will be used Dent Med Probl 2016 53 4 468-475
0 Light transmission unchanged
1 Shadow visible in enamel
2 Shadow visible in dentin
Plaque Control Record The Plaque Control Record O Leary T Drake R Naylor 1972 is a simple method of recording the presence of the plaque on individual tooth surfaces
At the study visits a suitable disclosing solution such as Bismarck Brown Diaplac or similar is painted on tooth surfaces After the subject has rinsed the investigator using an explorer or a tip of a probe examines each stained surface for soft accumulations at the dentogingival junction
After all teeth are examined and scored the index is calculated by dividing the number of plaque containing surfaces by the total number of available surfaces
Plaque Index Calculation The number of plaque containing surfaces The total number of available surfaces
The aim of this clinical trial is to assess in cohorts of adults whether 2 x daily tooth brushing at home over an observation period of 18 months with a fluoride-free microcrystalline hydroxyapatite HAP - containing test toothpaste has a non-inferior caries preventing effect in the permanent dentition compared to the regular use of a fluoride control toothpaste 1450 ppm F- with proven caries preventive efficacy Walsh et al 2019 The study is designed as a multicentre two armed non-inferiority trial and will be performed by 2 study centres in Poland Caries development will be assessed by the Decay Missing Filling Surface Index DMFS
There are planned 4 visits for all subjects included to the project Description of the 4 visits is presented below
Visit 1 Screening and Baseline Study day 0 informed consent screening collection of baseline data and study inclusion Subjects potentially suitable for the study will be informed by the investigator about the nature sig-nificance and scope of the clinical trial according to the requirements described in the written subject information
Before study inclusion the willingness of the subjects to properly follow the study protocol during the complete treatment period of 546 days must be assessed Only when subjects have given their written informed consent heshe will be included as study participant
Subjects have to meet all inclusion criteria and no exclusion criteria Unsuitable subjects with un-treated caries in need of a restoration can become eligible after restorative therapy
Once informed consent has been given an initial examination will take place that covers the follow-ing aspects
Screening subjects for study eligibility inclusion and exclusion criteria
Demographic data Assessment of the study parameters has to be done on all teeth in the following sequence
Plaque control record PCR
Professional tooth cleaning
DMFS
DIAGNOcam After the analysis of the plaque control record using a plaque-staining solution see O Leary T Drake R Naylor 1972 a professional tooth cleaning will be performed Thereafter no fluoride gelvarnish etc will be applied
Finally the study subjects receive an electric toothbrush with 3 brushing heads replacement of the brushing head every 2 months and the allocated toothpaste test or control by a trained study nurse or dentist not involved in clinical study examinations
Proper use of the assigned electric toothbrush and the issued toothpaste is also instructed by this study nurse or a dentist not involved in the clinical study examinations
Visit 2 Study day 182 28 days at most 1st follow-up examination 182 days after baseline visit the following parameters are reassessed
Plaque control record PCR
Caries status DMFS as described for the baseline visit Subsequently a study nurse or a dentist not involved in clinical study examinations will hand out 3 new brushing heads for the electric toothbrush and a new supply of the assigned experimental toothpaste test or control for the next 182 days
Furthermore the study nurse will subsequently check the efficacy of the oral hygiene efforts of the subjects and if PCR will be 15 will train again with the subjects an efficacious brushing tech-nique Finally subjects receive a new appointment for visit 3
Visit 3 Study day 364 28 days at most 2nd follow-up examination 364 days after baseline visit the following parameters are reassessed
Plaque control record PCR
DMFS as described for the baseline visit Subsequently a study nurse or a dentist not involved in the clinical study examinations will hand out 3 new brushing heads for the electric toothbrush and a new supply of the assigned experimental toothpaste test or control for the next 182 days
Furthermore the study nurse will subsequently check the efficacy of the oral hygiene efforts of the subjects and if PCR will be 15 will train again with the subjects an efficacious brushing tech-nique Finally subjects receive a new appointment for visit 4
Visit 4 Study day 546 28 days at most final visit 546 days after baseline visit the following assessments are repeated
Plaque control record PCR
Professional tooth cleaning
DMFS
DIAGNOcam as described for the baseline visit
Methods of Determining Efficacy and Safety Methods of Determining Efficacy DMFS-index and PCR-scores will be determined by clinical examinations of the oral cavity In addi-tion analysis of mineral density using DIAGNOcam will be conducted according to the instructions of the manufacturer
Assessments of all clinical findings will be performed only by experienced dentists
DMFS Index Calculation The DMFS Index Decayed Missed Filled Surfaces is one of the most common methods in oral epidemiology for assessing dental caries prevalence as well as dental treatment needs among populations
DMFS Index calculation There are five surfaces on the posterior teeth facial lingual mesial distal and occlusal There are four surfaces on anterior teeth facial lingual mesial and distal The third molars are not counted
When a carious lesion or both a carious lesion and a restoration are present the surface is listed as a D
When a tooth has been extracted due to caries it is listed as an M
When a permanent filling is present or when a filling is defective but not decayed this surface is counted as an F Surfaces restored for reasons other than caries are not counted as an F
The total count is 128 surfaces
DIAGNOcam KaVo Dental DIAGNOcam will be used according to the instructions of the manufacturer The following classifi-cation will be used Dent Med Probl 2016 53 4 468-475
0 Light transmission unchanged
1 Shadow visible in enamel
2 Shadow visible in dentin
Plaque Control Record The Plaque Control Record O Leary T Drake R Naylor 1972 is a simple method of recording the presence of the plaque on individual tooth surfaces
At the study visits a suitable disclosing solution such as Bismarck Brown Diaplac or similar is painted on tooth surfaces After the subject has rinsed the investigator using an explorer or a tip of a probe examines each stained surface for soft accumulations at the dentogingival junction
After all teeth are examined and scored the index is calculated by dividing the number of plaque containing surfaces by the total number of available surfaces
Plaque Index Calculation The number of plaque containing surfaces The total number of available surfaces
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