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

NCT ID: NCT07229105

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-12
• Study Completion Date: 2025-03-28

Brief Summary

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).

Detailed 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).

Conditions

White Spot Lesions; Demineralization; Dental Caries; Orthodontic Treatment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A: Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group B: Casein Phosphopeptide-Amorphous Calcium Phosphate

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

Group Type: EXPERIMENTAL

GC Tooth Mousse

Intervention Type: DEVICE

Participants applied a pea-sized amount of GC Tooth Mousse into each aligner once daily before bedtime. They wore the aligners with the mousse for 15 minutes and were instructed not to rinse for 30 minutes post-application.

Group C: Nano-Hydroxyapatite

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.

Group Type: EXPERIMENTAL

Nano-Hydroxyapatite Gel

Intervention Type: DEVICE

A combined protocol involving: 1) Professional in-office application of 5% nHAp gel (BioWhiten ProOffice) at baseline, 1 month, and 3 months; and 2) Daily home application of 1% nHAp gel (Biowhiten Nanocare) into aligners every night before sleep.

Group D: Professional Fluoride Varnish

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

Group Type: EXPERIMENTAL

Sodium Fluoride varnish

Intervention Type: DRUG

Professional application of 5% sodium fluoride varnish (ProShield) to all tooth surfaces, with special attention to attachment margins, at baseline and 3 months. The varnish was left for 1 minute contact time before removal, with instructions not to eat/drink for 2 hours.

Interventions

GC Tooth Mousse

Participants applied a pea-sized amount of GC Tooth Mousse into each aligner once daily before bedtime. They wore the aligners with the mousse for 15 minutes and were instructed not to rinse for 30 minutes post-application.

Intervention Type: DEVICE

Nano-Hydroxyapatite Gel

A combined protocol involving: 1) Professional in-office application of 5% nHAp gel (BioWhiten ProOffice) at baseline, 1 month, and 3 months; and 2) Daily home application of 1% nHAp gel (Biowhiten Nanocare) into aligners every night before sleep.

Intervention Type: DEVICE

Sodium Fluoride varnish

Professional application of 5% sodium fluoride varnish (ProShield) to all tooth surfaces, with special attention to attachment margins, at baseline and 3 months. The varnish was left for 1 minute contact time before removal, with instructions not to eat/drink for 2 hours.

Intervention Type: DRUG

Other Intervention Names

CPP-ACP Paste; BioWhiten ProOffice and Nanocare; ProShield Varnish

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Banu Kılıç

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bezmialem Vakif University, Faculty of Dentistry

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

09/15

Identifier Type: -

Identifier Source: org_study_id