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临床试验/NCT03997552
NCT03997552招募中不适用

Non-Incised Papillae Surgical Approach (NIPSA) Versus Marginal Approach by Palatal Incision and Minimally Invasive Surgical Technique (MIST) in Periodontal Regeneration: a Ramdomized Clinical Trial

Universidad de Murcia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年9月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Probing pocket depth (PD)

研究概览

简要总结

Three techniques for periodontal reconstruction will be compared, in which marginal access versus apical access will be carried out.

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, Outcomes Assessor)

入排标准

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

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

Non-incised papillae surgical approach (NIPSA)

Experimental

To access the defect, a single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The incision will be extended mesiodistally as necessary to allow access to the defect and correct debridement of the granulation tissue. The tissue coronal to the incision will be raised full thickness, trying to maintain the preoperative papillae architecture intact. The granulation tissue and epithelium of the pocket will be eliminated. The affected root will be scaled and planed, and calculus eliminated. Once the defect will be debrided, the enamel matrix derivates will be applied. Then the incision line will be sutured by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures.

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

marginal approach by palatal incision

Active Comparator

A small incision in the palatal aspect and a limited papila elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces.

干预措施: marginal approach by palatal incision (Procedure)

Minimally invasive surgical technique (MIST)

Active Comparator

The incision of the defect-associated papilla will be performed according to the principles of the papilla preservation techniques. Enamel matrix derivates will be applied on the debrided root surfaces. Stable primary closure of the flaps will be obtained with internal modified mattress sutures.

干预措施: Minimally invasive surgical technique (MIST) (Procedure)

结局指标

主要结局

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.

Bleeding on probing

时间窗: 12 months

Bleeding on probing could be positive or negative.

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.

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.

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.

次要结局

未报告次要终点

研究者

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

Antonio José Ortiz Ruiz, MD

Professor and researcher

Universidad de Murcia

研究点 (1)

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