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Completed

NCT Number: NCT02705456

Enamel Caries in Orthodontic Patients

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.

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Key information

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Periodontology, University Hospital Wuerzburg

Würzburg, 97070, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tooth Brushing HA

Procedure

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 FL

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • Goethe University
  • University Hospital Dresden
  • University Hospital Munich
  • University Hospital Regensburg

Registry information

Acronym: ECOP

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 10, 2016
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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