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

NCT07229105 | Completed

• 1 other identifier: 09/15
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

White Spot Lesions; Demineralization; Dental Caries; Orthodontic Treatment

Keywords

clear aligners; Orthodontic Attachments; DIAGNOdent; White Spot Lesions; White Spot Lesion

Outcome Measures

Primary Outcomes (1)

• Change in Enamel Demineralization (DIAGNOdent values).

  Measurements taken using DIAGNOdent pen around attachment margins. Validated cut-off values: 0-12 sound, 13-24 initial, \>25 advanced.

  Baseline (T0) to 6 months (T3).

Secondary Outcomes (1)

• Temporal Changes in Enamel Mineralization

  1 month (T1) and 3 months (T2)

Study Arms (4)

Group A: Control

NO INTERVENTION

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

Group B: Casein Phosphopeptide-Amorphous Calcium Phosphate

EXPERIMENTAL

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

Device: GC Tooth Mousse

Group C: Nano-Hydroxyapatite

EXPERIMENTAL

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.

Device: Nano-Hydroxyapatite Gel

Group D: Professional Fluoride Varnish

EXPERIMENTAL

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

Drug: Sodium Fluoride varnish

Interventions

GC Tooth Mousse 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.

Also known as: CPP-ACP Paste

Group B: Casein Phosphopeptide-Amorphous Calcium Phosphate

Nano-Hydroxyapatite Gel 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.

Also known as: BioWhiten ProOffice and Nanocare

Group C: Nano-Hydroxyapatite

Sodium Fluoride varnish 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.

Also known as: ProShield Varnish

Group D: Professional Fluoride Varnish

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University, Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Bifluorid 12

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: August 12, 2024
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication
• Access Criteria: Researchers can contact the corresponding author.

Locations

TU (1)