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临床试验/NCT03997578
NCT03997578
招募中
不适用

Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Enamel Matrix Derivated and Xenograft for the Treatment of Periodontal Defects: A Controlled Clinical Trial

Universidad de Murcia1 个研究点 分布在 1 个国家目标入组 40 人2019年9月3日

概览

阶段
不适用
干预措施
NIPSA (Non-incised papilla surgical approach)
疾病 / 适应症
Periodontitis
发起方
Universidad de Murcia
入组人数
40
试验地点
1
主要终点
Recession (REC)
状态
招募中
最后更新
2个月前

概览

简要总结

The present study pretends to show the results of combining a modification of the Non-incised papillae surgical approach (NIPSA) attempting to improve the outcome in the treatment of teeth with advanced periodontal support loss.

注册库
clinicaltrials.gov
开始日期
2019年9月3日
结束日期
2027年2月2日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Antonio José Ortiz Ruiz, MD

Professor and researcher

Universidad de Murcia

入排标准

入选标准

  • patients diagnosed with periodontitis.
  • plaque index and bleeding index of \< 30%.
  • periodontal lesions with pocket probing depth \> 5 mm.
  • intrabony defect \> 3 mm.
  • intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.

排除标准

  • patients with systemic diseases that contraindicated treatment.
  • third molars.
  • teeth with incorrect endodontic or restorative treatment.

研究组 & 干预措施

NIPSA

Patients will be treated with only NIPSA technique.

干预措施: NIPSA (Non-incised papilla surgical approach)

NIPSA plus Connective tissue graft

Patients will be treated with NIPSA technique associated to a connective tissue graft.

干预措施: NIPSA plus connective tissue graft

结局指标

主要结局

Recession (REC)

时间窗: 12 months

Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.

Location of the tip of the papillae (TP)

时间窗: 12 months

Location of the tip of the papillae. Taking as reference the level of the mid-axis of the tooth, will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise. This outcome will be assessed with a periodontal probe and measured in mmm.

Probing pocket depth (PD)

时间窗: 12 months

Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket.

Clinical attachment level (CAL)

时间窗: 12 months

Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket.

Keratinized tissue width (KT)

时间窗: 12 months

Keratinized tissue width will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.

Bleeding on probing

时间窗: 12 months

Bleeding on probing could be positive or negative.

研究点 (1)

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