跳至主要内容
临床试验/NCT05861193
NCT05861193进行中(未招募)不适用

Treatment of NCCL Asociated With Gingival Recession With B.O.P.T. Technique

University of Valencia2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
25
试验地点
2
主要终点
On the tooth to be treated: Measurement of the volume of gingiva at the level of the gingival margin (before/after treatment).

研究概览

简要总结

The purpose of this clinical trial is to evaluate the gingival margin changes resulting from the treatment with biologically oriented preparation technique (B.O.P.T.) of non-carious cervical lesions (NCCL). In particular, the quantification of the cervical margin is carried out by an intraoral scanning device, both in length and width.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years of age, all sex;
  • Presence of a non-carious lesion with loss of dental hard tissue, located in the cervical third of the tooth, and associated with R1 Cairo dental recession; as well, the tooth must be in a healthy condition.

排除标准

  • In the tooth to be treated: presence of tartar, periodontal pocket, gingival hypertrophy and/or dental mobility grades II and III; as well as presence of necrosis, fractures and prosthetic restorations;
  • Presence of diabetes, coagulopathies, hemostatic and hormonal alterations, smoking habit of more than 10 cigarettes/day;
  • Patients being treated with drugs whose side effects may cause gingival hypertrophy (eg hydantoins);
  • Presence of any physical and/or mental condition that prevents voluntary giving informed consent to participate in the study.

结局指标

主要结局

On the tooth to be treated: Measurement of the volume of gingiva at the level of the gingival margin (before/after treatment).

时间窗: The initial scan is performed prior to treatment, lasting approximately 5 minutes (maximum). The final scan is performed three month after treatment, once the gingival tissues have healed.

The volume of the gingival tissue at the level of the margin, is measured through an initial intraoral scan, at 3 fixed points (the same points measured in the gingival recession, see outcome 1), from the outermost part of the gingiva to the outermost portion of the tooth root, seen in an occlusal view. A software allows to overlay the initial scan with the post treatment scan; thus, the volumetric changes obtained thanks to the treatment in the gingival margin are objectively measured.

On the tooth to be treated: Measurement of gingival recession associated to abfraction (before/after treatment).

时间窗: The initial scan is performed prior to treatment, lasting approximately 5 minutes (maximum). The final scan is performed three month after treatment, once the gingival tissues have healed.

The gingival recession associated with the abfraction lesion is digitally measured (in mm) through intraoral scanning of the same. Gingival recession is measured from the most coronal portion of the gingival margin to the cementoenamel junction at 3 fixed points (in mesial, medial, and distal). A software allows to overlay the initial scan with the post treatment scan; thus, the changes obtained thanks to the treatment in the height of the gingival margin are objectively measured.

次要结局

  • Periodontal probing of all teeth(Before and after 3 months post-treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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