Dental CariesECOPNCT02705456
Enamel Caries in Orthodontic Patients
A study testing Tooth Brushing HA and Tooth Brushing FL in people with Dental Caries, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
This randomized double-blind two arm controlled clinical trials evaluates the hypothesis that the regular use of a tooth paste containing microcrystalline hydroxylapatite provides a caries preventive effect in caries-susceptible individuals undergoing orthodontic therapy with fixed appliances which is comparable to… Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Tooth Brushing HA and Tooth Brushing FL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Dec 2016
- 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 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy juveniles and young adults with caries-promoting mutans streptococci colonization seeking orthodontic therapy with fixed orthodontic appliances
Who cannot join
- Oral ulcers
- Caries lesions on the buccal aspects of teeth 15-25
- Unrestored caries on any tooth
- Regular use of medications interfering with salivary flow and/or gingival inflammation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Periodontology, University Hospital Wuerzburg
Würzburg, 97070
About this study
This randomized double-blind two arm controlled clinical trials evaluates the hypothesis that the regular use of a tooth paste containing microcrystalline hydroxylapatite provides a caries preventive effect in caries-susceptible individuals undergoing orthodontic therapy with fixed appliances which is comparable to the caries preventive effect provided by the regular use of a fluoridated tooth paste.
Read the detailed description
Introduction
According to the criteria of evidence based medicine the use of fluoridated tooth paste as well as fluoridated mouth rinses are,with the exception of dietary control, the only proven measures for the prevention of dental caries.
Aim, Study Hypothesis
The aim of this randomized double-blind, two arm, controlled clinical trial is evaluation of the hypothesis that the regular use of a tooth paste containing microcrystalline particles of hydroxylapatite in caries-active subjects under orthodontic therapy with fixed appliances will provide at least a comparable extent of caries prevention as the regular use of fluoridated tooth paste during an observation period of 6 months.
Material and Methods
Study subjects will be recruited from juveniles and young adults, age 12-25, displaying high (≥105 CFU) salivary counts of caries promoting mutans streptococci and seeking orthodontic therapy with fixed appliances. Evaluated parameters are the presence of enamel caries on the buccal aspects of teeth 15-25 according to the criteria of the International Caries Detection and Assessment System (ICDAS), the presence of gingival inflammation assessed by the Gingival Index (GI) the presence of microbial plaque on the evaluated teeth assessed by the Plaque Index (PlI) and the extent of mutans streptococci colonization (MS) on the evaluated teeth and in saliva using standardized cultivation techniques. Primary endpoint of the study is the number and severity of enamel caries lesions according to the ICDAS classification. Exclusion criteria are the presence of ICDAS lesion ≥ 3 on the buccal surfaces of teeth 15-25, the presence of gingival lesions > GI 2 and the regular use of salivary flow-reducing medications.
At baseline, ICDAS scores, as well as GI, PlI and MS will be recorded followed by the incorporation of the fixed orthodontic appliances. Subsequently, using a random list participants are provided with a standardized electric tooth brush and a supply of one of the two experimental tooth pastes (hydroxylapatite(HA)/fluoride (FL)) to be used 2 x daily for the next 6 months. HA-tooth paste contains no fluoride, FL-tooth paste contains stannous fluoride and amine fluoride. At days 28, 84 and 168 (end of study) ICDAS, GI, PlI and MS are recorded again. Additionally all study participants will receive a full mouth preventive professional supragingival tooth cleaning followed by the application of a 1% chlorhexidine gel on all tooth surfaces once every 4 weeks during the course of the trial.
- Conditions
- Dental Caries
- Being tested
- Tooth Brushing HA, Tooth Brushing FL
- Keywords
- Dental Caries, Tooth Paste, Orthodontics, Fluorides
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth Brushing HAProcedure or surgery
2x daily repeated cleaning of all teeth using a standardized electric tooth brush and a non-fluoridated tooth paste containing microcrystalline hydroxylapatite.
Professional supragingival tooth cleaning once every 4 weeks with a rubber cup followed by the application of a 1% chlorhexidine gel over the duration of the study (24 weeks).
Tooth Brushing FLProcedure or surgery
2x daily repeated cleaning of all teeth using a standardized electric tooth brush and a fluoridated tooth paste.
Professional supragingival tooth cleaning once every 4 weeks with a rubber cup followed by the application of a 1% chlorhexidine gel over the duration of the study (24 weeks).
| Study group | Role | What they receive |
|---|---|---|
| HA-Tooth Paste | Experimental | Tooth Brushing HA
Cleaning of all teeth using a standardized electric tooth brush and a non-fluoridated tooth paste containing microcrystalline hydroxylapatite twice daily over the duration of the study (24 weeks).
Professional caries prevention by professional supragingival tooth cleaning and the subsequent application of a 1% chlorhexidine gel once every 4 weeks over the duration of the study (24 weeks). Receives: Procedure: Tooth Brushing HA |
| FL-Tooth Paste | Active comparator | Tooth Brushing FL
Cleaning of all teeth using a standardized electric tooth brush and a fluoridated tooth paste twice daily over the duration of the study (24 weeks).
Professional caries prevention by professional supragingival tooth cleaning and the subsequent application of a 1% chlorhexidine gel once every 4 weeks over the duration of the study (24 weeks). Receives: Procedure: Tooth Brushing FL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of developing enamel caries lesions
Recording of newly developing enamel caries lesions according to the International Caries Detection and Assessment System (ICDAS)
Measured: 168 days (24 weeks)
Secondary outcomes (3)
Gingival Inflammation using the Gingival Index
Assessment of gingival inflammation using the Gingival Index
Measured: 168 days (24 weeks)
Plaque Coverage using the Plaque Index
Assessment of bacterial plaque coverage using the Plaque Index (Silness u. Loe 1964)
Measured: 168 days (24 weeks)
Mutans Streptococci Colonization
Assessment of mutans streptococci colonization in saliva and on tooth surfaces
Measured: 168 days (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startOct 2014
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Regensburg, University Hospital Munich, University Hospital Dresden, Goethe University
- Responsible party
- Principal investigator, Prof. Dr. Ulrich Schlagenhauf, Wuerzburg University Hospital
- Investigators
- Ulrich Schlagenhauf, Prof. Dr., Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705456
- Sponsor's protocol ID
- ECOP1
- Acronym
- ECOP
- Status last verified
- May 2017
- First submitted
- 25 Feb 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Schlagenhauf U, Kunzelmann KH, Hannig C, May TW, Hosl H, Gratza M, Viergutz G, Nazet M, Schamberger S, Proff P. Impact of a non-fluoridated microcrystalline hydroxyapatite dentifrice on enamel caries progression in highly caries-susceptible orthodontic patients: A randomized, controlled 6-month trial. J Investig Clin Dent. 2019 May;10(2):e12399. doi: 10.1111/jicd.12399. Epub 2019 Jan 30.
PubMed 30701704
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enamel Caries in Orthodontic Patients
- ClinicalTrials.gov ID
- NCT02705456
- Acronym / sponsor ID
- ECOP / ECOP1
- Conditions
- Dental Caries
- Keywords
- Dental Caries, Tooth Paste, Orthodontics, Fluorides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- University Hospital Regensburg, University Hospital Munich, University Hospital Dresden, Goethe University
- Study start
- Oct 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Mar 2016 (estimated)
- 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.
This randomized double-blind two arm controlled clinical trials evaluates the hypothesis that the regular use of a tooth paste containing microcrystalline hydroxylapatite provides a caries preventive effect in caries-susceptible individuals undergoing orthodontic therapy with fixed appliances which is comparable to the caries preventive effect provided by the regular use of a fluoridated tooth paste.
Detailed description
Introduction
According to the criteria of evidence based medicine the use of fluoridated tooth paste as well as fluoridated mouth rinses are,with the exception of dietary control, the only proven measures for the prevention of dental caries.
Aim, Study Hypothesis
The aim of this randomized double-blind, two arm, controlled clinical trial is evaluation of the hypothesis that the regular use of a tooth paste containing microcrystalline particles of hydroxylapatite in caries-active subjects under orthodontic therapy with fixed appliances will provide at least a comparable extent of caries prevention as the regular use of fluoridated tooth paste during an observation period of 6 months.
Material and Methods
Study subjects will be recruited from juveniles and young adults, age 12-25, displaying high (≥105 CFU) salivary counts of caries promoting mutans streptococci and seeking orthodontic therapy with fixed appliances. Evaluated parameters are the presence of enamel caries on the buccal aspects of teeth 15-25 according to the criteria of the International Caries Detection and Assessment System (ICDAS), the presence of gingival inflammation assessed by the Gingival Index (GI) the presence of microbial plaque on the evaluated teeth assessed by the Plaque Index (PlI) and the extent of mutans streptococci colonization (MS) on the evaluated teeth and in saliva using standardized cultivation techniques. Primary endpoint of the study is the number and severity of enamel caries lesions according to the ICDAS classification. Exclusion criteria are the presence of ICDAS lesion ≥ 3 on the buccal surfaces of teeth 15-25, the presence of gingival lesions > GI 2 and the regular use of salivary flow-reducing medications.
At baseline, ICDAS scores, as well as GI, PlI and MS will be recorded followed by the incorporation of the fixed orthodontic appliances. Subsequently, using a random list participants are provided with a standardized electric tooth brush and a supply of one of the two experimental tooth pastes (hydroxylapatite(HA)/fluoride (FL)) to be used 2 x daily for the next 6 months. HA-tooth paste contains no fluoride, FL-tooth paste contains stannous fluoride and amine fluoride. At days 28, 84 and 168 (end of study) ICDAS, GI, PlI and MS are recorded again. Additionally all study participants will receive a full mouth preventive professional supragingival tooth cleaning followed by the application of a 1% chlorhexidine gel on all tooth surfaces once every 4 weeks during the course of the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA-Tooth Paste | Experimental | Procedure: Tooth Brushing HATooth Brushing HA Cleaning of all teeth using a standardized electric tooth brush and a non-fluoridated tooth paste containing microcrystalline hydroxylapatite twice daily over the duration of the study (24 weeks). Professional caries prevention by professional supragingival tooth cleaning and the subsequent application of a 1% chlorhexidine gel once every 4 weeks over the duration of the study (24 weeks). |
| FL-Tooth Paste | Active comparator | Procedure: Tooth Brushing FLTooth Brushing FL Cleaning of all teeth using a standardized electric tooth brush and a fluoridated tooth paste twice daily over the duration of the study (24 weeks). Professional caries prevention by professional supragingival tooth cleaning and the subsequent application of a 1% chlorhexidine gel once every 4 weeks over the duration of the study (24 weeks). |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy juveniles and young adults with caries-promoting mutans streptococci colonization seeking orthodontic therapy with fixed orthodontic appliances
Key exclusion criteria (4 listed)
- Oral ulcers
- Caries lesions on the buccal aspects of teeth 15-25
- Unrestored caries on any tooth
- Regular use of medications interfering with salivary flow and/or gingival inflammation
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 |
|---|---|---|
| Tooth Brushing HA2x daily repeated cleaning of all teeth using a standardized electric tooth brush and a non-fluoridated tooth paste containing microcrystalline hydroxylapatite. Professional supragingival tooth cleaning once every 4 weeks with a rubber cup followed by the application of a 1% chlorhexidine gel over the duration of the study (24 weeks). | Procedure or surgery | HA-Tooth Paste |
| Tooth Brushing FL2x daily repeated cleaning of all teeth using a standardized electric tooth brush and a fluoridated tooth paste. Professional supragingival tooth cleaning once every 4 weeks with a rubber cup followed by the application of a 1% chlorhexidine gel over the duration of the study (24 weeks). | Procedure or surgery | FL-Tooth Paste |
Primary outcome
Number of developing enamel caries lesions
Time frame: 168 days (24 weeks)
Recording of newly developing enamel caries lesions according to the International Caries Detection and Assessment System (ICDAS)
3 secondary outcomes
Gingival Inflammation using the Gingival Index
Time frame: 168 days (24 weeks)
Plaque Coverage using the Plaque Index
Time frame: 168 days (24 weeks)
Mutans Streptococci Colonization
Time frame: 168 days (24 weeks)
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 9 May 2017.
- Derived from this study: PubMed 30701704Schlagenhauf U, Kunzelmann KH, Hannig C, May TW, Hosl H, Gratza M, Viergutz G, Nazet M, Schamberger S, Proff P. Impact of a non-fluoridated microcrystalline hydroxyapatite dentifrice on enamel caries progression in highly caries-susceptible orthodontic patients: A randomized, controlled 6-month trial. J Investig Clin Dent. 2019 May;10(2):e12399. doi: 10.1111/jicd.12399. Epub 2019 Jan 30.
- Individual participant dataSharing planned: Undecided
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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.
Ulrich Schlagenhauf, Prof. Dr. principal investigator
Wuerzburg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth Brushing HA and Tooth Brushing FL in people with Dental Caries, run by Wuerzburg University Hospital at 1 site in Germany.
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 1 inclusion and 4 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 9 May 2017. 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 Germany. 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?
Number of developing enamel caries lesions (time frame: 168 days (24 weeks)). 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 NCT02705456, which also lists 1 linked publication.
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 9 May 2017.