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Randomized clincial trial on the efficacy of caries infiltration during treatment with fixed orthodontic appliances

Randomized clincial trial on the efficacy of caries infiltration during treatment with fixed orthodontic appliances

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011797
Enrollment
30
Registered
2017-03-06
Start date
2017-04-01
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

Interventions

Group 1: This is a monocentric, randomized, controlled study in split-mouth design. The teeth with the lesions are divided into two groups: Group A (test group): The WSLs will be infiltrated without

Sponsors

Klinik für Zahnerhaltung, Präventiv- und Kinderzahnmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 70 Years

Inclusion criteria

Inclusion criteria: •Females and males at age between 12 and 70 years •WSL developed throughout an orthodontic treatment with fixed devices in the region between teeth 14 and 24 also between 34 and 44 •Lesions with an ICDAS stage 1 or 2 (non-cavitated caries) •Written consent of the patients or the parents after clarification

Exclusion criteria

Exclusion criteria: •Incompatibility of one of the ingredients or contact allergies •Cavitated lesions (ICDAS 3-6) •Signs that the participant is not expected to comply with the protocol (e.g. lack of cooperation) •Pregnancy or lactation period

Design outcomes

Primary

MeasureTime frame
In the planed randomized clinical study, three aspects should be tested -one week after treatment -concerning to the caries infiltration (test group) and sloely intensive fluoridation (control group = standard treatment) , of WSL developed during ongoing orthodontic treatment with fixed appliances: 1. the extent and severity of the WSL one week after treatment during the bracket treatment 2. The effect of masking of the caries-infiltration one week after treatment during the bracket treatment 3. The arresting or the progression of the infiltrated as well as the control lesions one week after the treatment during the bracket treatment

Secondary

MeasureTime frame
In the planed randomized clinical study, three aspects should be tested after removal of the brackets concerning to the caries infiltration (test group) and sloely intensive fluoridation (control group = standard treatment) , of WSL developed during ongoing orthodontic treatment with fixed appliances: 1. The extent and severity of the WSL after removal of the brackets 2. The effect of masking of the caries-infiltration after removal of the brackets 3. The arresting or the progression of the infiltrated as well as the control lesions after removal of the brackets

Countries

Germany, Greece

Contacts

Public ContactFidaa;Richard Shikh Ali;Wierichs

Kieferorthopädische Praxis Dr.med.dent. Youssef Cheaib;Klinik für Zahnerhaltung, Präventiv- und Kinderzahnmedizin

fidaa-s-ali@posteo.de;richard.wierichs@unibe.ch04241/7303;+41 31 684 06 50

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 11, 2026