Caries,Dental Clinical Trial
Official title:
A Prospective Randomized Controlled Trial for Prevention of Enamel White Spot Lesions During Fixed Orthodontic Treatment
Verified date | April 2020 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Treatment with fixed orthodontic appliances is often associated with pain, which poses great
challenges in the efficient brushing of the teeth thus making the teeth more vulnerable to
plaque formation. Treatment duration with fixed orthodontic appliances usually extends to 18
months or even longer in some cases. This prolonged vulnerability to plaque formation
frequently leads to demineralization of teeth. There is also an increase in the number of
plaque retentive sites due to the fixed appliances, leading to a rapid change in the
bacterial composition of the dental plaque, particularly in the number of acidogenic
bacteria. The resulting enamel decalcification is also known as white spot lesions (WSLs),
which is an early sign of demineralization of enamel. Enamel WSLs (EWSLs) can be observed
even as early as four weeks from the start of fixed orthodontic treatment. The occurrence of
EWSLs adjacent to the orthodontic brackets ranges from 15 to 85%.
The incidence of EWSLs development is higher in orthodontic patients as compared to the
development of similar lesions in non-orthodontic patients. These EWSLs are not aesthetically
pleasing and is certainly unacceptable when it develops during fixed orthodontic treatment
that is usually performed in patients who often seek such treatment to improve their
aesthetics. Additionally, even if the outcome of fixed orthodontic treatment is superior from
well-aligned teeth, aesthetics can be greatly compromised with EWSLs. Therefore, the
prevention of such lesions is an important concern for orthodontists.
Though professionally applied topical fluoride varnish helps in remineralization of EWSLs, an
adequate supply of calcium and phosphate ions is essential for remineralization. Therefore,
EWSLs on maxillary teeth could be prevented and remineralized by the use of advanced novel
topical fluoride varnish with added calcium and phosphate-based delivery system.
Status | Active, not recruiting |
Enrollment | 99 |
Est. completion date | July 30, 2021 |
Est. primary completion date | March 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Subjects about to undergo multi-bracketed fixed orthodontic treatment will be invited to participate in this study. Exclusion Criteria: 1. History of fixed orthodontic treatment 2. Presence of any developmental defects of enamel (DDE) on labial surfaces of teeth 3. Presence of any dental anomalies or direct/indirect labial restorations on teeth 4. History of long-term antibiotic usage 5. Presence of untreated cavitated lesions 6. Plaque level greater than 25% 7. Patients requiring complicated orthognathic surgeries |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria) | Changes in EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated clinically). The Gorelick's index is graded as: 0 (no lesion), 1(moderate lesion), 2 (severe lesion) and 3 (cavitation) with lower score representing good outcome and higher score representing poor outcome. |
24 months | |
Primary | Change in Enamel White Spot Lesions index surface scores: Photographic evaluation (Subjective criteria) | Changes in EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated photographically). The Gorelick's index is graded as: 0 (no lesion), 1(moderate lesion), 2 (severe lesion) and 3 (cavitation) with lower score representing good outcome and higher score representing poor outcome |
24 months | |
Primary | Change in Laser fluoroscence values (Objective criteria) | Changes in mean DIAGNOdent scores among three study groups. The DIAGNOdent values (or laser fluorescence values) are visible on the device as digital readings from 0 to 99 with higher readings representing poor outcomes and lower readings representing good outcomes. | 24 months | |
Secondary | Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria) | EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated clinically) | 6 months | |
Secondary | Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria) | EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated clinically) | 12 months | |
Secondary | Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria) | EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated clinically) | 18 months | |
Secondary | Enamel White Spot Lesions index surface scores: Photographic evaluation (Subjective criteria) | EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated photographically) | 6 months | |
Secondary | Enamel White Spot Lesions index surface scores: Photographic evaluation (Subjective criteria) | EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated photographically) | 12 months | |
Secondary | Enamel White Spot Lesions index surface scores: Photographic evaluation (Subjective criteria) | EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated photographically) | 18 months | |
Secondary | Laser fluoroscence evaluation (Objective criteria) | Mean DIAGNOdent scores among three study groups | 6 months | |
Secondary | Laser fluoroscence evaluation (Objective criteria) | Mean DIAGNOdent scores among three study groups | 12 months | |
Secondary | Laser fluoroscence evaluation (Objective criteria) | Mean DIAGNOdent scores among three study groups | 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05792800 -
Dental Practitioners KAP Regarding Caries Preventive Measures in Cairo and Riyadah
|
||
Not yet recruiting |
NCT05792215 -
KAP of Dental Practitioners Regarding CRA
|
||
Withdrawn |
NCT04104789 -
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - General
|
Phase 2 | |
Active, not recruiting |
NCT06211582 -
Clinical Performances of 3-different Tooth-colored Restorative Materials in Class-II Cavities
|
N/A | |
Recruiting |
NCT05362461 -
Diagnostic Ability of Near Infrared Transillumination Detecting Interproximal Caries as Compared to Conventional Bitewing Radiographs
|
||
Not yet recruiting |
NCT04422860 -
Remineralization Efficacy of Gum Arabic Varnish.
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT06063239 -
Probiotics in Special Needs Patients at High Risk for Tooth Decay: a Randomized Controlled Trial.
|
N/A | |
Completed |
NCT04286256 -
Using Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood Caries
|
N/A | |
Completed |
NCT06182267 -
Maximal Use Study to Determine the Pharmacokinetics of L-arginine After Exaggerated Oral Use of COL101
|
Phase 1 | |
Not yet recruiting |
NCT03671200 -
Correlation Between Caries Experience in Primary Molars and First Permanent Molars
|
||
Not yet recruiting |
NCT06365281 -
Caries Prevalence, Experience and Risk Related Factors Among Early Middle-aged Patients Attending Cairo University
|
||
Completed |
NCT06242184 -
Post-operative Sensitivity in Resin Composites
|
N/A | |
Completed |
NCT04003493 -
LifE Style, Nutrition and Oral Health in Care Givers (LENTO)
|
N/A | |
Enrolling by invitation |
NCT04251858 -
Evaluation of Oral Condition and the Effect of Dental Treatment on Physical Parameters of Athletes
|
N/A | |
Terminated |
NCT01796106 -
Clinical Trial Proximal Caries Infiltration and Detection
|
N/A | |
Not yet recruiting |
NCT05943782 -
Evaluation of CAD/CAM Onlays Fabricated by Subtractive Versus Additive Digital Manufacturing Techniques.
|
N/A | |
Recruiting |
NCT06114030 -
Clinical and Radiographical Evaluation of CAD-CAM Crowns With and Without Deep Margin Elevation
|
N/A | |
Recruiting |
NCT05756413 -
Birth to Three - Cavity Free
|
N/A | |
Not yet recruiting |
NCT04303767 -
The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine
|
Phase 2 | |
Completed |
NCT05231330 -
Clinical Evaluation of Silver Nanoparticles in Comparison to Silver Diamine Fluoride in Management of Deep Carious Lesions
|
N/A |