Effectiveness of anti-caries clear aligner in reversal of post orthodontic white spot lesions

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300072665

Enrollment

Unknown

Registered

2023-06-20

Start date

2023-06-30

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic white spot lesions

Interventions

Group A:During the first period, subjects will be asked to wear anti-caries clear aligners. During the second period, they will wear the clear aligner (without anti-caries component).

Group B:During the first period, subjects will be asked to wear the clear aligner (without anti-caries component). During the second period, they will wear anti-caries clear aligners.

Eligibility

Sex/Gender

All

Age

12 Years to 22 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged 12-22 years; (2) Patients who have completed fixed orthodontic treatment (double jaw) within half a year; (3) Permanent dentition; (4) White spot lesions on the labial surface of the maxillary / mandibular anterior teeth = 1 tooth (Gorelick's scale score 1 or 2); (5) Signing the informed consent and voluntarily participating in the clinical trial.

Exclusion criteria

Exclusion criteria: (1) Resin fillings, veneers, crowns or other restorations in the maxillary/mandibular anterior teeth; (2) history of orthognathic surgery; (3) Patients with cleft lip and palate; (4) Patients with active caries; (5) Periodontal pocket depth= 3mm; (6) History of smoking; (7) Pregnant women or those who are trying to become pregnant during the trial; (8) Structural dysplasia of anterior teeth: enamel hypoplasia, fluorosis, tetracycline teeth, etc.; (9) Patients with white spot lesions on the anterior teeth before orthodontic treatment; (10) Accompanied by other systemic diseases or long-term use of antibiotics; (11) Patients with hand disabilities or unable to brush their teeth on their own.

Design outcomes

Primary

Measure	Time frame
WSL area;	—

Secondary

Measure	Time frame
Integrated optical dentisy;DIAGNOdent? Pen value;Gorelick’s scale;color change (?E);Patient reported VAS score regarding the aesthetic of anterior teeth;gingival index;	—

Countries

China

Contacts

Public ContactHong He

School & Hospital of Stomatology, Wuhan University

drhehong@whu.edu.cn+86 189 7166 2305

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026