Enamel Caries in Orthodontic Patients (ECOP)

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Procedure: Tooth Brushing HA; Procedure: Tooth Brushing FL

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Wuerzburg, Germany, 97070
    • Dept. of Periodontology, University Hospital Wuerzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of developing enamel caries lesions	Recording of newly developing enamel caries lesions according to the International Caries Detection and Assessment System (ICDAS)	168 days (24 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Inflammation using the Gingival Index	Assessment of gingival inflammation using the Gingival Index	168 days (24 weeks)
Plaque Coverage using the Plaque Index	Assessment of bacterial plaque coverage using the Plaque Index (Silness u. Loe 1964)	168 days (24 weeks)
Mutans Streptococci Colonization	Assessment of mutans streptococci colonization in saliva and on tooth surfaces	168 days (24 weeks)

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Collaborators: Goethe University; University Hospital Munich; University Hospital Regensburg; University Hospital Dresden
• Investigators: Principal Investigator: Ulrich Schlagenhauf, Prof. Dr., Wuerzburg University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Dental Caries; Orthodontics; Fluorides; Tooth Paste
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: ECOP1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED