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Enamel Caries in Orthodontic Patients (ECOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02705456
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : May 9, 2017
Sponsor:
Collaborators:
University Hospital Regensburg
University Hospital Munich
University Hospital Dresden
University Hospital, Frankfurt
Information provided by (Responsible Party):
Prof. Dr. Ulrich Schlagenhauf, Wuerzburg University Hospital

Brief 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 the caries preventive effect provided by the regular use of a fluoridated tooth paste.

Condition or disease Intervention/treatment Phase
Dental Caries Procedure: Tooth Brushing HA Procedure: Tooth Brushing FL Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Enamel Caries in Orthodontic Patients
Study Start Date : October 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: HA-Tooth Paste

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).

Procedure: Tooth Brushing HA

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).


Active Comparator: FL-Tooth Paste

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).

Procedure: Tooth Brushing FL

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).





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Gingival Inflammation using the Gingival Index [ Time Frame: 168 days (24 weeks) ]
    Assessment of gingival inflammation using the Gingival Index

  2. Plaque Coverage using the Plaque Index [ Time Frame: 168 days (24 weeks) ]
    Assessment of bacterial plaque coverage using the Plaque Index (Silness u. Loe 1964)

  3. Mutans Streptococci Colonization [ Time Frame: 168 days (24 weeks) ]
    Assessment of mutans streptococci colonization in saliva and on tooth surfaces



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy juveniles and young adults with caries-promoting mutans streptococci colonization seeking orthodontic therapy with fixed orthodontic appliances

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705456


Locations
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Germany
Dept. of Periodontology, University Hospital Wuerzburg
Wuerzburg, Germany, 97070
Sponsors and Collaborators
Wuerzburg University Hospital
University Hospital Regensburg
University Hospital Munich
University Hospital Dresden
University Hospital, Frankfurt
Investigators
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Principal Investigator: Ulrich Schlagenhauf, Prof. Dr. Wuerzburg University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. Ulrich Schlagenhauf, Chairman Dept. of Periodontology, Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT02705456    
Other Study ID Numbers: ECOP1
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Prof. Dr. Ulrich Schlagenhauf, Wuerzburg University Hospital:
Dental Caries
Tooth Paste
Orthodontics
Fluorides
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases