The Effect of Oxalic Acid on Cervical Restorations on Hypersensitive Teeth, a Double-blind Randomized Controlled Clinical Trial. One Year Follow up

University of Chile0 个研究点目标入组 31 人开始时间: 2012年1月1日最近更新: 2014年12月3日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 31
主要终点: teeth sensitivity by EVA

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The aim of this double-blind randomized controlled clinical trial was to evaluate the effect on dentin sensitivity using oxalic acid desensitizing agent before restoring with resin-based-composites, during one-year follow-up. One hundred and twenty two cervical lesions (31 patients, age range between 24 and 66 years) were selected and randomly divided into four groups: OA/Z250: treated with acid oxalic desensitizing agent (Desenssiv, SSWhite) before restoring with a methacrylate resin-based-composite (Z250, 3M ESPE), (n=31), OA/P90 treated with acid oxalic desensitizing agent (Desenssiv, SSWhite) before restoring with a silorane resin-based-composite (Silorane p90, 3M ESPE) (n=31), Z250 restored with methacrylate resin-based-composite (Z250, 3M ESPE) (n=30) and P90 restored with a silorane resin-based-composite (Silorane p90, 3M ESPE) (n=30). All lesions were evaluated at baseline, immediately and 1, 2, 3, 6 months and 1 year after treatment. Teeth sensitivity was measured by visual analog scale (VAS) after evaporation and tactile stimuli

详细描述

The study design was a split-mouth placebo-controlled randomized clinical trial according to CONSORT recommendations. Patients were recruited in the Clinic of Dental School of University of Chile according to inclusion criteria.All patients signed the informed consent approved by the Ethics Committee (Dental School, Universidad de Chile).

Inclusion criteria were:

Patients older than 18 years old having at least 4 teeth with cervical buccal lesions sensitive to tactile and thermal/evaporation stimuli. (moderate / severe pain by EVA)
Teeth with surface loss on the buccal cervical area with indication of resin-composite-based restoration.

Exclusion criteria were:

Systemic diseases related to chronic pain
Pregnancy
Recent periodontal surgery, orthodontic treatment or desensitizing treatment within the last 3 months.
In treatment with NSAIDs
Teeth with caries or restorations
Incisor teeth (to avoid cross innervation).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Patients older than 18 years old having at least 4 teeth with cervical buccal lesions sensitive to tactile and thermal/evaporation stimuli. (moderate / severe pain by EVA)
•Teeth with surface loss on the buccal cervical area with indication of resin-composite-based restoration.

排除标准

•-Systemic diseases related to chronic pain
•Pregnancy
•Recent periodontal surgery, orthodontic treatment or desensitizing treatment within the last 3 months.
•In treatment with NSAIDs
•Teeth with caries or restorations
•Incisor teeth (to avoid cross innervation).

研究组 & 干预措施

z250 resin composite

Placebo Comparator

(n=31) Treated with distilled water (placebo) and restored with a methacrylate resin-based-composite (Z250, 3M ESPE, shade: A3)

z250 resin composite + oxalic acid

Active Comparator

(n=31) treated with 0.5% oxalic acid (Desenssiv, SSWhite)(intervention)// and restored with a methacrylate resin-based-composite (Z250, 3M ESPE, shade: A3)

干预措施: with 0,5% oxalic acid (Desenssiv SSWhite) (Other)

p 90 resin composite

Placebo Comparator

(n=31) Treated with distilled water (placebo) and restored with a silorane resin-based-composite.

p 90 resin composite + oxalic acid

Active Comparator

(n=31) treated with 0,5% oxalic acid (Desenssiv SSWhite)(Intervention)/ and restored with a silorane resin-based-composite (Filtek Silorane p90, £M ESPE, shade:)

干预措施: with 0,5% oxalic acid (Desenssiv SSWhite) (Other)