Dental Caries Clinical Trial
Official title:
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04127929 -
Investigation of Glass Carbomer Performance
|
N/A | |
| Completed |
NCT04769882 -
Er:YAG Laser Effects on Microbial Population in Conservative Dentistry
|
N/A | |
| Completed |
NCT04971317 -
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
|
N/A | |
| Active, not recruiting |
NCT04475679 -
Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy
|
N/A | |
| Completed |
NCT05438381 -
Comparison of Clinical and Radiographic Outcomes of SMART Technique vs ART in Primary Molars
|
N/A | |
| Not yet recruiting |
NCT03037814 -
Clinical Performance of Restorative Materials in Primary Teeth
|
N/A | |
| Active, not recruiting |
NCT05202665 -
Resin Infiltration and Fluoride Varnish Lesion Arresting Efficacy on Non-cavitated Proximal Lesion
|
N/A | |
| Terminated |
NCT01147835 -
Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers
|
N/A | |
| Not yet recruiting |
NCT04033263 -
Maintaining Oral Health With Bio-products
|
N/A | |
| Enrolling by invitation |
NCT04438252 -
Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions
|
N/A | |
| Not yet recruiting |
NCT03609034 -
Knowledge, Attitude and Practice of a Group of Egyptian Dental Interns Toward Caries Risk Assessment
|
||
| Completed |
NCT02912000 -
TEACH: Technology Evaluation to Address Child Health
|
N/A | |
| Completed |
NCT02473107 -
Impact of Detecting Initial and Active Caries Lesions in Primary Teeth
|
N/A | |
| Active, not recruiting |
NCT02537184 -
Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children
|
N/A | |
| Completed |
NCT01950546 -
Nanosilver Fluoride to Prevent Dental Biofilms Growth
|
Phase 1 | |
| Recruiting |
NCT02734420 -
Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial
|
Phase 1 | |
| Completed |
NCT02020681 -
Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions
|
N/A | |
| Completed |
NCT02426619 -
Arresting Active Dental Caries in Preschool Children by Topical Fluorides
|
Phase 2/Phase 3 | |
| Completed |
NCT02234609 -
Effectiveness of Modified Class IV Atraumatic Restorative Treatment
|
N/A | |
| Withdrawn |
NCT01224002 -
A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine
|
N/A |