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Comparative effectiveness of ProSeal Sealant and Elmex Fluid for preventing white-spot lesions and gingivitis in fixed orthodontic treatment of patients - a randomized controlled trial

Comparative effectiveness of ProSeal Sealant and Elmex Fluid for preventing white-spot lesions and gingivitis in fixed orthodontic treatment of patients - a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00023697
Enrollment
128
Registered
2020-11-26
Start date
2020-12-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

K02.0 K05.0 K05.1 K03.6

Interventions

Group 1: INTERVENTION 1: Instructions on home oral hygiene and nutrition INTERVENTION 2: Application of the fluoride-releasing and light-curing fluorescence sealer Pro Seal INTERVENTION 3: independent

Sponsors

Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: • Patients before the start of a fixed orthodontic therapy using the buccal technique (in both dental arches) with a minimum expected treatment duration of 6 months at the examining orthodontist (no move, etc.) • Bonding of the brackets in the upper and lower arches on the same day (T0) • no previous or interrupted fixed orthodontic therapy • at least 15 permanent incisors, canines and premolars present or erupted in both dental arches (5-5) • At least 15 permanent anterior teeth and premolars in both dental arches are intended to be affixed with a bracket (=15 tooth surfaces / participant).

Exclusion criteria

Exclusion criteria: • Patients = 18 years (adults) • Pregnancy or breastfeeding • Application of a dental fluoride varnish or a sealer within the last 12 months • Changes in the enamel on the teeth (fluorosis, hypocalcification, etc.) • Fillings and restorations in buccal tooth surfaces (glued with brackets) • Syndrome patients and patients with limited oral hygiene skills or ability to properly conduct the study • Systemic, endocrine or oral diseases (diabetes, periodontitis, open oral wounds / ulcers, etc.), poor general condition • Alcohol / drug abuse, long-term medication / antisialoga / steroids or other drugs that affect saliva, biofilm or the tooth support system in the last 6 months • Local fluoride content in domestic drinking water> 0.2ppm F- • Allergy / intolerance to fluorides or the preparations used • Missing written declaration of consent • Patients who do not agree to comply with the study protocol (no additional fluoride intake / PZR, dental treatment in consultation with an orthodontist, oral hygiene behavior, etc.)

Design outcomes

Primary

MeasureTime frame
ICDAS-II-INDEX - Measurement of the white spot / caries progression by clinical-visual assessment of the extent of the enamel demineralization / initial caries on the buccal tooth surfaces with a score (Likhert scale). Times: T-1, recruitment: Appointment at least 30 days before the start of fixed orthodontic therapy; T0, baseline: after bonding the brackets and removing excess bonding material; T1, 3 months: after 3 months of fixed therapy; T2, 6 months: after 6 months of fixed therapy (in case of coincidence with the end of therapy BEFORE debonding); T3: immediately AFTER debonding ENAMEL DECALCIFICATION INDEX (EDI) - Measurement of the white spot / caries extension by visual assessment of the extent of the enamel demineralization using intraoral photo status recordings with a score (Likhert scale). Points in time: T0, baseline: after the brackets have been bonded and the excess plastic removed; T1, 3 months: after 3 months of fixed therapy; T2, 6 months: after 6 months of fixed therapy (in case of coincidence with the end of therapy BEFORE debonding); T3: immediately AFTER debonding

Secondary

MeasureTime frame
MODIFIED PLAQUE INDEX ACCORDING TO SILNESS / LÖE (MPI) - clinical-visual assessment of the extent of plaque accumulation on the buccal tooth surfaces with a score (Likhert scale). Times: T-1, recruitment: Appointment at least 30 days before the start of fixed orthodontic therapy, at which the patient is selected as a potential study participant; T0, baseline: before teeth cleaning and brackets bonding (at the beginning of the session); T1, 3 months: after 3 months of fixed therapy; T2, 6 months: after 6 months of fixed therapy; T3: immediately AFTER debonding GINGIVAL INDEX ACCORDING TO SILNESS / LÖE (1963) - clinical-visual assessment of the extent of gingivitis per gingival margin / tooth with a score (Likhert scale). Times: T-1, recruitment: Appointment at least 30 days before the start of fixed orthodontic therapy, at which the patient is selected as a potential study participant; T0, baseline: before teeth cleaning and brackets bonding (at the beginning of the session); T1, 3 months: after 3 months of fixed therapy; T2, 6 months: after 6 months of fixed therapy; T3: immediately AFTER debonding

Countries

Germany

Contacts

Public ContactChristian Kirschneck

Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg

christian.kirschneck@ukr.de+499419446093

Outcome results

None listed

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