Status
Conditions
Treatments
About
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).
Full 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, he/she 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:
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:
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:
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:
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.
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
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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Medical Reasons
Other Reasons:
Primary purpose
Allocation
Interventional model
Masking
192 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal