NCT02705456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

1.8 years

First QC Date

February 25, 2016

Last Update Submit

May 8, 2017

Conditions

Dental Caries

Keywords

Dental CariesTooth PasteOrthodonticsFluorides

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Gingival Inflammation using the Gingival Index

    168 days (24 weeks)

  • Plaque Coverage using the Plaque Index

    168 days (24 weeks)

  • Mutans Streptococci Colonization

    168 days (24 weeks)

Study Arms (2)

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).

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).

Procedure: Tooth Brushing FL

Interventions

Tooth Brushing HAPROCEDURE

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).

HA-Tooth Paste
Tooth Brushing FLPROCEDURE

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).

FL-Tooth Paste

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Periodontology, University Hospital Wuerzburg

Würzburg, 97070, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30701704DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Ulrich Schlagenhauf, Prof. Dr.

    Wuerzburg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman Dept. of Periodontology

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 10, 2016

Study Start

October 1, 2014

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

DE(1)