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临床试验/NCT07283393
NCT07283393进行中(未招募)不适用

Observational Prospective Study on Resective and Regenerative Periodontal Therapy: Short & Longterm Follow-up

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月1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
30
试验地点
1
主要终点
Probing depth

研究概览

简要总结

Periodontitis is a common inflammatory disease affecting approximately 40% of the Belgian population.

The goal of this observational study is to learn about the treatment outcomes of surgical periodontal therapy in adults with periodontitis.

The main questions this study aims to answer are:

  • Does subsequent surgical intervention further improve periodontal health parameters?
  • Is there any significant difference between treatment outcomes of resective and regenerative periodontal surgery.

Participants will:

- Undergo surgical periodontal treatment if residual pocket depth ≥6 mm persists despite good oral hygiene.

Study inclusion was performed after surgical treatment.

- Be screened on various intervals. If there is any recurrent periodontitis, adequate treatment will be performed

In short term, pocket probing depth is our primary outcome and tooth survival is the outcome in the long term.

Secondary outcomes in short-term are bone level, mobility, bleeding on probing, tooth survival and cost-effectiveness.

Long-term outcomes (>5 years) are probing pocket depth, bone level, tooth sensitivity, mobility, bleeding on probing and cost-effectiveness.

详细描述

Periodontitis is a common condition, affecting approximately 40% of the Belgian populations. The condition most common characteristics are bleeding of the gingiva and bone loss. Left untreated, this disease can lead to severe loss of maxillary or mandibulary bone. Treatment for primary stages of periodontitis don't always require surgical interventions; correction of oral hygiene and deep cleaning the teeth combined, if necessary, with extraction of irrational to treat elements under local anesthesia can be sufficient. Three months after initial treatment, at the re-evaluation, the depth of the tooth pockets, bleeding on probing, mobility and the amount of regression of the gums are reassessed. If the depth of the tooth pockets regressed insuffient, with a depth of at least six milimeters, eventhough the patients oral hygiene is acceptable, further surgical treatment is necessary. A patient is not able to clean these greater pockets.

Resective or regenerative surgery was performed, based on the bone morphology and the patients characteristics.

Inclusion of patients in this study was performed after surgical treatment. Research parameters will be evaluated at 6 months, 1 year, 3 years, 5 years, 7 and 10 years after surgery.

The main questions this study aims to answer are:

  • Does subsequent surgical intervention further improve periodontal health parameters?
  • Is there any significant difference between treatment outcomes of resective and regenerative periodontal surgery.

研究设计

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

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

  • Min 18 years of age
  • Max 6 months since resective or regenerative periodontal surgery
  • Good general health

排除标准

  • Pregnancy and breastfeeding

结局指标

主要结局

Probing depth

时间窗: At 6 months, 1 year, 3 years, 5 years, 7 years and 10 years of follow-up

Probing depth evolution in the short term

Tooth retention

时间窗: From enrollment to the end of the study, at 10 years of follow up

Survival of tooth in the long-term follow-up

次要结局

  • Radiographic bone level(6 months, 3 years, 5 years, 7 years and 10 years)
  • Tooth mobility(At 6 months, 1 year, 3 years, 5, 7 and 10 years of follow-up.)
  • Bleeding on probing(At 6 months, 1 year, 3 years, 5, 7 and 10 years of follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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