Comparative Effectiveness of Remineralization Agents on Attachment-Associated Demineralization in Clear Aligner Patients

Bezmialem Vakif University

Status: Completed

Conditions: Orthodontic Treatment; Demineralization; Dental Caries; White Spot Lesions

Treatments: Drug: Sodium Fluoride varnish; Device: Nano-Hydroxyapatite Gel; Device: GC Tooth Mousse

Study type: Interventional

Funder types: Other

Identifiers

NCT07229105

09/15

Details and patient eligibility

About

Background/ Objectives: Clear aligner attachments increase the risk of white spot lesions (WSL), with a 35.5% incidence in adolescents. The number of anterior attachments is an independent risk factor (OR=2.192). Despite 17 million patients treated worldwide, no study has quantitatively assessed demineralization around attachment margins. To compare the effectiveness of CPP-ACP, nano-hydroxyapatite (nHAp), and fluoride varnish versus a control for attachment-associated demineralization using DIAGNOdent monitoring.

Methods: This prospective observational study evaluated 52 patients; 45 were enrolled, and 40 completed after five pre-baseline withdrawals. Participants were allocated to four groups (n=10 each): Group A (control, fluoride toothpaste), Group B (CPP-ACP daily), Group C (nHAp professional + home gel), and Group D (fluoride varnish quarterly). DIAGNOdent measurements were taken around attachments at baseline, 1, 3, and 6 months. Linear mixed-effects models analyzed group differences (p<0.05).

Full description

DIAGNOdent Measurement Protocol Calibration and Standardization The DIAGNOdent pen (KaVo, Biberach, Germany) was calibrated before each measurement session according to the manufacturer's instructions using a ceramic standard[18]. A single calibrated examiner performed all measurements to ensure consistency. Intra-examiner reliability was assessed using intraclass correlation coefficient (ICC) with two-way mixed model, absolute agreement, calculated from 30 repeated measurements at 10 randomly selected attachment sites (ICC = 0.85, 95% CI: 0.79-0.91).

Measurement Technique A standardized measurement protocol was employed for all DIAGNOdent assessments. Teeth were air-dried for 5 seconds prior to measurement, and the probe tip was positioned perpendicular to the enamel surface to ensure consistent readings. Four measurements were obtained per attachment site at the mesial, distal, gingival, and occlusal margins. Three measurement passes were performed at each site, with the maximum value recorded to represent the most advanced demineralization present. Measurements were conducted at four timepoints: baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3).

Enrollment: 40 patients

Sex: All

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 16-45 years
• Active clear aligner treatment with minimum 6 months remaining
• Presence of ≥10 attachments on anterior teeth and premolars
• Good general health
• Commitment to prescribed aligner wear (20-22 hours/day)

Exclusion criteria

• Active carious lesions
• Periodontal disease
• Fluorosis or enamel hypoplasia
• Current fluoride supplement use beyond standard toothpaste
• Pregnancy or lactation
• Systemic conditions affecting salivary flow

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Group A: Control

No Intervention group

Description:

The participants used standard fluoride toothpaste (1450 ppm) twice daily, with no additional remineralization protocol.

Group B: Casein Phosphopeptide-Amorphous Calcium Phosphate

Experimental group

Description:

In addition to standard fluoride toothpaste, participants applied GC Tooth Mousse (CPP-ACP) to their clear aligners once daily for 15 minutes before bedtime.

Treatment:

Device: GC Tooth Mousse

Group C: Nano-Hydroxyapatite

Experimental group

Description:

Professional in-office application of 5% nHAp gel at baseline, 1, and 3 months, combined with daily home application of 1% nHAp gel into aligners.

Treatment:

Device: Nano-Hydroxyapatite Gel

Group D: Professional Fluoride Varnish

Experimental group

Description:

Professional application of 5% sodium fluoride varnish (ProShield) applied to attachment margins at baseline and 3 months.

Treatment:

Drug: Sodium Fluoride varnish