Dental CariesCA1NCT04756557
Caries-preventing Effect of a Hydroxyapatite-toothpaste in Adults
A study testing Experimental. and Active comparator in people with Dental Caries and Hydroxyapatite, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Hydroxyapatite, Tooth Decay
- What is being tested?
- Experimental. and Active comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2021to 9 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- provision of written informed consent
- age 18-45 years (both men and women)
- a minimum of 10 healthy molars and premolars (DMFS of these teeth = 0)
- willing to use an electric (powered) toothbrush
Who cannot join
- Medical Reasons
- untreated caries [clinical investigation and analysis with DI-AGNOcam] (→ unsuitable subjects with untreated caries in need of a restoration can become eligible after restorative therapy)
- severe periodontitis at the baseline-visit (pocket depth on at least one tooth ≥ 5.5 mm)
- orthodontic treatment
- known hypersensitivity to one of the ingredients of the tooth-pastes to be tested
- systemic disorders interfering with salivary function or flow
Show all 11Show fewer
- regular medication intake interfering with salivary function or flow
- Other Reasons:
- Participation in any other clinical study within the past 3 months or ongoing
- lack of intellectual or physical ability to conduct the study properly
- Any other reason that, in the opinion of the investigator, dis-qualifies the subject from participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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, 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:
- 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 gel/varnish 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
- = Shadow visible in enamel
- = 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
- Conditions
- Dental Caries, Hydroxyapatite, Tooth Decay, Dentin, Carious, Enamel Caries
- Being tested
- Experimental., Active comparator
- Keywords
- tooth demineralization, cariostatic agent, protective agent, toothpaste
- Medical subject headings
- Dental Caries, Tooth Demineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental.Other
Also called Karex Toothpaste with 10% Hydroxyapatite
Tooth Brushing HAP 2x daily repeated cleaning of all teeth 3 min. using a standardized electric tooth brush Electric (powered) toothbrushes (Oral-B; P\&G, Schwalbach, Germany), brushing head: medium; will be changed every 2 months and a non-fluoridated tooth paste containing microcrystalline hydroxyapatite . HAP-toothpaste (Karex toothpaste with 10 % hydroxyapatite) If a subject shows multiple carious lesions during the course of the study, the study dentist will decide whether the subject must be excluded from the study. In this case the subject will receive additional intensive caries prophylactic measures (e.g. chlorhexi-dine gel application, dietary counselling, etc.). Caries preventive treatment (removing caries and placing a restoration) by the study centers is offered.
Active comparatorOther
Also called Karex Base with sodium fluoride 1450 F-
Tooth Brushing F 2x daily repeated cleaning of all teeth 3min.using a standardized electric tooth brush ((Oral-B; P\&G, Schwalbach, Germany) and a fluoridated toothpaste (Karex Base with sodium fluoride 1450 F-), brushing head: medium; will be changed every 2 months If a subject shows multiple carious lesions during the course of the study, the study dentist will decide whether the subject must be excluded from the study. In this case the subject will receive additional intensive caries prophylactic measures (e.g. chlorhexidine gel application, dietary counselling, etc.). Caries preventive treatment (removing caries and placing a restoration) by the study centers is offered.
| Study group | Role | What they receive |
|---|---|---|
| Tooth Brushing HAP Toothpaste | Experimental | Experimental: Tooth Brushing HAP HAP-Toothpaste Tooth Brushing HAP Prophylactic cleaning of all teeth using a standardized electric tooth brush and a non-fluoridated toothpaste containing microcrystalline hydroxylapatite two x daily over the duration of the study (18 months).
Procedure: Tooth Brushing HAP Receives: Other: Experimental. |
| Tooth Brushing F Toothpaste | Active comparator | Cleaning teeth using a standardized electric tooth brush and a fluoridated tooth paste containing amino fluoride (1450 ppm F-), (two x daily over the duration of the study (18 months). Receives: Other: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects showing no increase in overall DMFS-index
Proportion of subjects showing no increase in overall DMFS-index (DMFSVisit 4 - DMFSVisit 1 = 0) during the observation period
Measured: 546 days
Secondary outcomes (2)
roportion of subjects experiencing no change in mineral density
- Proportion of subjects experiencing no change in mineral density (as analyzed by DIAGNOcam) during the observation period of time
Measured: 546 days
Changes in the coverage of all teeth with bacterial plaque ac-cording to the criteria of the Plaque Control Record
- Changes in the coverage of all teeth with bacterial plaque ac-cording to the criteria of the Plaque Control Record (PCR; O'Leary et al. 1972)
Measured: 546 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, double-blind, randomized, active-controlled parallel-group study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Bialystok, Dr. Kurt Wolff GmbH & Co. KG
- Responsible party
- Principal investigator, Elzbieta Paszynska, Poznan University of Medical Sciences
- Investigators
- Elzbieta Paszynska, Prof, Principal investigator, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756557
- Sponsor's protocol ID
- PoznanUMS
- Acronym
- CA1
- Status last verified
- Jan 2023
- First submitted
- 11 Feb 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we do not plan any individual participant data available data to other researchers
Publications
Walsh T, Worthington HV, Glenny AM, Marinho VC, Jeroncic A. Fluoride toothpastes of different concentrations for preventing dental caries. Cochrane Database Syst Rev. 2019 Mar 4;3(3):CD007868. doi: 10.1002/14651858.CD007868.pub3.
PubMed 30829399Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802.
PubMed 23268518Paszynska E, Pawinska M, Gawriolek M, Kaminska I, Otulakowska-Skrzynska J, Marczuk-Kolada G, Rzatowski S, Sokolowska K, Olszewska A, Schlagenhauf U, May TW, Amaechi BT, Luczaj-Cepowicz E. Impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial. Sci Rep. 2021 Jan 29;11(1):2650. doi: 10.1038/s41598-021-81112-y.
PubMed 33514787Amaechi BT, AbdulAzees PA, Alshareif DO, Shehata MA, Lima PPCS, Abdollahi A, Kalkhorani PS, Evans V. Comparative efficacy of a hydroxyapatite and a fluoride toothpaste for prevention and remineralization of dental caries in children. BDJ Open. 2019 Dec 9;5:18. doi: 10.1038/s41405-019-0026-8. eCollection 2019.
PubMed 31839988Hummel R, Akveld NAE, Bruers JJM, van der Sanden WJM, Su N, van der Heijden GJMG. Caries Progression Rates Revisited: A Systematic Review. J Dent Res. 2019 Jul;98(7):746-754. doi: 10.1177/0022034519847953. Epub 2019 May 9.
PubMed 31070943O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
PubMed 4500182Poulsen VJ. Caries risk children in the Danish child dental service. Scand J Prim Health Care. 1987 Sep;5(3):169-75. doi: 10.3109/02813438709013999.
PubMed 3671918Tschoppe P, Zandim DL, Martus P, Kielbassa AM. Enamel and dentine remineralization by nano-hydroxyapatite toothpastes. J Dent. 2011 Jun;39(6):430-7. doi: 10.1016/j.jdent.2011.03.008. Epub 2011 Apr 8.
PubMed 21504777Paszynska E, Pawinska M, Enax J, Meyer F, Schulze Zur Wiesche E, May TW, Amaechi BT, Limeback H, Hernik A, Otulakowska-Skrzynska J, Krahel A, Kaminska I, Lapinska-Antonczuk J, Stokowska E, Gawriolek M. Caries-preventing effect of a hydroxyapatite-toothpaste in adults: a 18-month double-blinded randomized clinical trial. Front Public Health. 2023 Jul 18;11:1199728. doi: 10.3389/fpubh.2023.1199728. eCollection 2023.
PubMed 37533523
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caries-preventing Effect of a Hydroxyapatite-toothpaste in Adults
- ClinicalTrials.gov ID
- NCT04756557
- Acronym / sponsor ID
- CA1 / PoznanUMS
- Conditions
- Dental Caries, Hydroxyapatite, Tooth Decay, Dentin, Carious, Enamel Caries
- Keywords
- tooth demineralization, cariostatic agent, protective agent, toothpaste
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Collaborators
- Medical University of Bialystok, Dr. Kurt Wolff GmbH & Co. KG
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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, 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:
- 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 gel/varnish 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
- = Shadow visible in enamel
- = 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, double-blind, randomized, active-controlled parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| Tooth Brushing HAP Toothpaste | Experimental | Other: Experimental.Experimental: Tooth Brushing HAP HAP-Toothpaste Tooth Brushing HAP Prophylactic cleaning of all teeth using a standardized electric tooth brush and a non-fluoridated toothpaste containing microcrystalline hydroxylapatite two x daily over the duration of the study (18 months). Procedure: Tooth Brushing HAP |
| Tooth Brushing F Toothpaste | Active comparator | Other: Active comparatorCleaning teeth using a standardized electric tooth brush and a fluoridated tooth paste containing amino fluoride (1450 ppm F-), (two x daily over the duration of the study (18 months). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- provision of written informed consent
- age 18-45 years (both men and women)
- a minimum of 10 healthy molars and premolars (DMFS of these teeth = 0)
- willing to use an electric (powered) toothbrush
Key exclusion criteria (11 listed)
- Medical Reasons
- Other Reasons:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental.Also: Karex Toothpaste with 10% HydroxyapatiteTooth Brushing HAP 2x daily repeated cleaning of all teeth 3 min. using a standardized electric tooth brush Electric (powered) toothbrushes (Oral-B; P\&G, Schwalbach, Germany), brushing head: medium; will be changed every 2 months and a non-fluoridated tooth paste containing microcrystalline hydroxyapatite . HAP-toothpaste (Karex toothpaste with 10 % hydroxyapatite) If a subject shows multiple carious lesions during the course of the study, the study dentist will decide whether the subject must be excluded from the study. In this case the subject will receive additional intensive caries prophylactic measures (e.g. chlorhexi-dine gel application, dietary counselling, etc.). Caries preventive treatment (removing caries and placing a restoration) by the study centers is offered. | Other | Tooth Brushing HAP Toothpaste |
| Active comparatorAlso: Karex Base with sodium fluoride 1450 F-Tooth Brushing F 2x daily repeated cleaning of all teeth 3min.using a standardized electric tooth brush ((Oral-B; P\&G, Schwalbach, Germany) and a fluoridated toothpaste (Karex Base with sodium fluoride 1450 F-), brushing head: medium; will be changed every 2 months If a subject shows multiple carious lesions during the course of the study, the study dentist will decide whether the subject must be excluded from the study. In this case the subject will receive additional intensive caries prophylactic measures (e.g. chlorhexidine gel application, dietary counselling, etc.). Caries preventive treatment (removing caries and placing a restoration) by the study centers is offered. | Other | Tooth Brushing F Toothpaste |
Primary outcome
Proportion of subjects showing no increase in overall DMFS-index
Time frame: 546 days
Proportion of subjects showing no increase in overall DMFS-index (DMFSVisit 4 - DMFSVisit 1 = 0) during the observation period
2 secondary outcomes
roportion of subjects experiencing no change in mineral density
Time frame: 546 days
Changes in the coverage of all teeth with bacterial plaque ac-cording to the criteria of the Plaque Control Record
Time frame: 546 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Background: PubMed 30829399Walsh T, Worthington HV, Glenny AM, Marinho VC, Jeroncic A. Fluoride toothpastes of different concentrations for preventing dental caries. Cochrane Database Syst Rev. 2019 Mar 4;3(3):CD007868. doi: 10.1002/14651858.CD007868.pub3.
- Results publication: PubMed 23268518Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802.
- Results publication: PubMed 33514787Paszynska E, Pawinska M, Gawriolek M, Kaminska I, Otulakowska-Skrzynska J, Marczuk-Kolada G, Rzatowski S, Sokolowska K, Olszewska A, Schlagenhauf U, May TW, Amaechi BT, Luczaj-Cepowicz E. Impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial. Sci Rep. 2021 Jan 29;11(1):2650. doi: 10.1038/s41598-021-81112-y.
- Results publication: PubMed 31839988Amaechi BT, AbdulAzees PA, Alshareif DO, Shehata MA, Lima PPCS, Abdollahi A, Kalkhorani PS, Evans V. Comparative efficacy of a hydroxyapatite and a fluoride toothpaste for prevention and remineralization of dental caries in children. BDJ Open. 2019 Dec 9;5:18. doi: 10.1038/s41405-019-0026-8. eCollection 2019.
- Results publication: PubMed 31070943Hummel R, Akveld NAE, Bruers JJM, van der Sanden WJM, Su N, van der Heijden GJMG. Caries Progression Rates Revisited: A Systematic Review. J Dent Res. 2019 Jul;98(7):746-754. doi: 10.1177/0022034519847953. Epub 2019 May 9.
- Results publication: PubMed 4500182O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
- Results publication: PubMed 3671918Poulsen VJ. Caries risk children in the Danish child dental service. Scand J Prim Health Care. 1987 Sep;5(3):169-75. doi: 10.3109/02813438709013999.
- Results publication: PubMed 21504777Tschoppe P, Zandim DL, Martus P, Kielbassa AM. Enamel and dentine remineralization by nano-hydroxyapatite toothpastes. J Dent. 2011 Jun;39(6):430-7. doi: 10.1016/j.jdent.2011.03.008. Epub 2011 Apr 8.
- Derived from this study: PubMed 37533523Paszynska E, Pawinska M, Enax J, Meyer F, Schulze Zur Wiesche E, May TW, Amaechi BT, Limeback H, Hernik A, Otulakowska-Skrzynska J, Krahel A, Kaminska I, Lapinska-Antonczuk J, Stokowska E, Gawriolek M. Caries-preventing effect of a hydroxyapatite-toothpaste in adults: a 18-month double-blinded randomized clinical trial. Front Public Health. 2023 Jul 18;11:1199728. doi: 10.3389/fpubh.2023.1199728. eCollection 2023.
- Individual participant dataSharing planned: No. we do not plan any individual participant data available data to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elzbieta Paszynska, Prof principal investigator
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental. and Active comparator in people with Dental Caries and Hydroxyapatite, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects showing no increase in overall DMFS-index (time frame: 546 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04756557, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.