Enamel Caries in Orthodontic Patients

Dental Caries Clinical Trial

— ECOP  

Official title:

Enamel Caries in Orthodontic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705456
• Other study ID #: ECOP1
• Status: Completed
• Phase: N/A
• First received: February 25, 2016
• Last updated: May 8, 2017
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

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).
• 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).

Locations

Country	Name	City	State
Germany	Dept. of Periodontology, University Hospital Wuerzburg	Wuerzburg

Sponsors (5)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	University Hospital Dresden, University Hospital Munich, University Hospital Regensburg, University Hospital, Frankfurt

Country where clinical trial is conducted

Germany, 

Outcome

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