8.3% Carbamide Peroxide 함유 펜 형 자가미백제인 BlancTis Forte의 색조개선 및 안전성에 관한 임상연구
CLINICAL STUDY OF SHADE IMPROVEMENT AND SAFETY OF POLYMER-BASED PEN TYPE BlancTis Forte WHITENING AGENT CONTAINING 8.3% CARBAMIDE PEROXIDE
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초록
8.3%의 carbamide peroxide를 함유한 펜형 코팅용 미백제인 BlancTis Forte (NIBEC, Seoul & JinCheon)를 실험군으로, 3% hydrogen peroxide를 함유한 Whitening Effect Pen (LG, Seoul) 제재를 대조군으로 각각 피험자 20명에게 2시간씩 1일 2회 제조사의 지시대로 치아표면에 4주간 적용하도록 지시하고 색조개선 효능과 안전성을 평가하였다. 미백 효과는 미백 전 및 미백 2주, 4주, 및 미백 종료 4주 후에 ShadepilotTM을 이용하여 색 변화를 측정하였고, 매 내원시기마다 모든 환자는 치수생활력 검사와 치주 및 치태 검사를 통해 부작용 여부 (치아과민증 및 구강 내 연조직의 부작용)를 기록한 후 다음과 같은 결과를 얻었다. 1. 실험군 및 대조군의 색 변화량 (ΔE)은 2이상으로 인지할 수 있는 색 변화를 보였으며, 두 제품 간에는 통계적으로 유의한 차이를 보이지 않아 (p > 0.05) 유사한 미백효능을 나타냄을 알 수 있었다. 2. 미백효과는 명도의 개선보다는 주로 a, b값의 변화에 의한 것으로 특히 실험군에서 b값의 변화, 즉 황색조의 개선 효과가 대조군에 비해 유의성 있게 높은 것으로 나타났다 (p < 0.05). 3. 치아나 치은의 과민증이나 이상증상을 호소하는 피험자는 없어 두 제품 모두 안전성을 확인할 수 있었다.
Abstract
This clinical study evaluated the whitening effect and safety of polymer based-pen type BlancTis Forte (NIBEC) containing 8.3% carbamide peroxide. Twenty volunteers used the BlancTis Forte whitening agent for 2 hours twice a day for 4 weeks. As a control, Whitening Effect Pen (LG) containing 3% hydrogen peroxide was used by 20 volunteers using the same protocol. The change in shade (ΔE*, color difference) was measured using ShadepilotTM (DeguDent) before, during, and after bleaching (2 weeks, 4 weeks, and postbleaching 4 weeks). A clinical examination for any side effects (tooth hypersensitivity or soft tissue complications) was also performed at each check-up. The following results were obtained. 1. Both the experimental and control groups displayed a noticeable change in shade (ΔE) of over 2. No significant differences were found between the two groups (p > 0.05), implying that the two agents have a similar whitening effect. 2. The whitening effect was mainly due to changes in a and b values rather than in L value (brightness). The experimental group showed a significantly higher change in b value, thus yellow shade, than the control (p < 0 .05). 3. None of the participants complained of tooth hypersensitivity or soft tissue complications, confirming the safety of both whitening agents.
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