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

Not Applicable

• Conditions: K02; Dental caries

• Registration Number: DRKS00011797
• Lead Sponsor: Klinik für Zahnerhaltung, Präventiv- und Kinderzahnmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-06
• Results First Posted: 2022-10-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

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

•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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>1. the extent and severity of the WSL one week after treatment during the bracket treatment<br>2. The effect of masking of the caries-infiltration one week after treatment during the bracket treatment<br>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 Outcome Measures

Name	Time	Method
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:<br>1. The extent and severity of the WSL after removal of the brackets<br>2. The effect of masking of the caries-infiltration after removal of the brackets<br>3. The arresting or the progression of the infiltrated as well as the control lesions after removal of the brackets<br>