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临床试验/NCT05721313
NCT05721313尚未招募不适用

Vital Root Amputation in Molars With Advanced Periodontal Furcation Involvement: a Preliminary Study

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10
试验地点
2
主要终点
No periapical lesion

研究概览

简要总结

The goal of this clinical trial is to test in 10 patients with advanced furcation involvement on molars. The main question[s] it aims to answer are:

• Is it possible to carry out root resection without endodontic treatment on molars? Tooth vitality will be checked (positive response to cold test). Root resection will be carried out under local anestesia.

Following visits will be carried out for re-evaluation/maintenance according to clinical care every 3 mounths until 3 years follow-up.

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

性别
All
接受健康志愿者

入选标准

  • Patient diagnosed with stage III-IV periodontitis
  • Compliantpatient, as shown by full mouth plaque score<30%
  • Previous non-surgical periodontal therapy within 6 mounths
  • Maxillary or mandibular molar affected by periodontal furcation involvement and scheduled for root resection
  • Positive to sensibility testing (cold/electric pulp tests)
  • No prosthesis or large restorations
  • Sufficiently divergent roots to make root resection feasible
  • Root trunk lenght at 3 mm as measured in periapical radiograph

排除标准

  • Systemic contraindications to perform periodontal surgery/root resection
  • Fused roots
  • Presence of periapical radiolucency
  • Furcation class III affecting all roots of maxillary molar

结局指标

主要结局

No periapical lesion

时间窗: 3-year follow-up

following the 3rd visit will be make a re-evaluation of the periapical heath condition, by a periapical rx, every year

Tooth vitality (positive response to cold test)

时间窗: 3-year follow-up

following the 3rd visit will be make a re-evaluation of the tooth vitality, by a positive response to cold test, every 3 month.

次要结局

未报告次要终点

研究者

发起方
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Barbagallo

DDS, DMD

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

研究点 (2)

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