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临床试验/NCT04016493
NCT04016493已完成不适用

Tunnel Versus Coronally Advanced Flap Combined With a Connective Tissue Graft for the Treatment of Gingival Recessions: Long Term (4 Years) Follow-up of a Randomized Controlled Trial

University of Liege0 个研究点目标入组 40 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Mean Root Coverage change

研究概览

简要总结

Few studies evaluate the outcomes beyond 1 year follow up for gingival recessions treatments using the tunnel technique in combination with connective tissue graft. The aim of this randomized controlled trial (RCT) was to compare the 4-year outcomes of the CAF versus the pouch/tunnel (TUN) technique both associated with CTG.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Miller's class I recessions;
  • Recession of 2 mm to 5 mm;
  • Maxillary incisors, canines or premolars;
  • Identifiable cementoenamel junction (CEJ);
  • Patients minimum 18 years old;
  • No/controlled periodontal disease;
  • ASA1 or ASA2 (American Society of Anesthesiologists) general health status;
  • Providing a signed informed consent form.
  • Exclusion criteria were:
  • Presence of cervical carious lesion;
  • Pocket depth greater than 4 mm;
  • Sites where previous muco-gingival therapy was performed;
  • Pregnancy.
  • In presence of non-carious cervical lesions, the anatomical CEJ was reconstructed by the use of a composite before the procedure.

排除标准

  • 未提供

结局指标

主要结局

Mean Root Coverage change

时间窗: at 6 months and 4 years.

The status of the Mean Root Coverage was recorded at 6 months and 4 years follow-up visits. The scale is in mm. More long it is, best it is Minest long it is, worst it is

Plaque Index Change

时间窗: baseline, 6 months and 4 years

The plaque accumulation is assessed at baseline, 6 months and 4 years follow-up visits using a 0-1 scoring system, 0 being the the highest value, 1 being the lowest result (0 =No detectible plaque ; 1 = Plaque can be seen by the naked eye)

Bleeding on probing score change

时间窗: baseline, 6 months and 4 years

The bleeding tendency is assessed at baseline, 6 months and 4 years follow-up visits as : 0 No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant; 1 Isolated bleeding spots visible ; 2 Blood forms a confluent red line on the margin; 3 Heavy or profuse bleeding.

Gingival thickness change

时间窗: baseline, 6 months and 4 years

The gingival thickness was recorded at baseline, 6 months and 4 years follow-up visits. The scale is in mm. More thick is it, best it is Minest thick it is, worst it is

Keratinised mucosa height change

时间窗: baseline, 6 months and 4 years

The status of the keratinised mucosa height was recorded at baseline, 6 months and 4 years follow-up visits. The scale is in mm. More large is it, best it is Minest large it is, worst it is

Recession width change

时间窗: baseline, 6 months and 4 years

The status of the recession width was recorded at baseline, 6 months and 4 years follow-up visits. The scale is in mm. More large is it, worst it is Minest large it is, best it is

PES Assessment change

时间窗: Baseline, 6 months and 4 years

The PES was assessed according to the seven parameters described by Fürhauser (Fürhauser et al., 2005).

次要结局

  • Patient-related esthetic outcomes(4 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. France LAMBERT

Prof.

University of Liege

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