跳至主要内容
临床试验/NCT05439382
NCT05439382进行中(未招募)不适用

Very Long-term Analysis of Root Coverage Stability Using Subepithelial Connective Tissue Graft Techniques for Gingival Recession Treatment.

Azienda Ospedaliero-Universitaria di Modena1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2022年6月30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
101
试验地点
1
主要终点
Periodontal pocket probing depth (PD)

研究概览

简要总结

One-hundred and one healthy participants (221 gingival recessions-GRs) were treated from 1987 to 1996. The probing depth (PD), keratinized tissue width (KTW), gingival recession depth (RD), gingival recession width (RW), gingival recession area (RA) were evaluated and considered at baseline and along time. The obtained data will be evaluated and compared.

详细描述

Dental-periodontal procedures and clinical measurements.

Dental and periodontal conditions were assessed and treated according to needs in all participants. Emergencies, such as pain or acute dental-periodontal infections, were treated to establish a stable dental-periodontal condition. Cause-related therapy, including patient motivation and professional oral hygiene, was planned and completed.

At the end of cause-related therapy, the following baseline clinical measurements were taken by an investigator: probing depth (PD), keratinized tissue width (KTW), full-mouth plaque scores (FMPS), full-mouth bleeding scores (FMBS), bleeding on probing (BoP), gingival recession depth (RD), gingival recession width (RW), and gingival recession area (RA).

PD and KTW were evaluated using a periodontal probe (University of North Carolina Probe 15 tip) to the nearest 0.5mm. PD was measured at 4 aspects per tooth axially, from the free gingival margin to the most apical part of the sulcus, and, additionally, PD at the mid buccal point; KTW at the mid-buccal point, from the free gingival margin to the mucogingival-junction (MGJ). FMPS was recorded as the percentage of total tooth surfaces (4 aspects per tooth) displaying the presence of plaque, FMBS was calculated as the percentage of total tooth surfaces (4 aspects per tooth) showing bleeding on probing (BoP) was dichotomously assessed.

The bi-dimensional shape of each exposed root surface was reproduced with a lead sheet template. The template had the shape of a triangle with a curved base lining the cemento-enamel-junction (CEJ) and two sides lining the mesial and distal margins of the GR merging at the most apical point of the GR. All templates were measured, coded and stored. The following measurements were recently repeated using an image analysis software: RD, from the most apical point of the triangle to the base; RW, measured at the CEJ level (i.e., at the base of the template) and RA, as the total template area.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Absence of relevant medical conditions: Medical history of good health. Good oral hygiene: full-mouth plaque score (FMPS) ≤20%. Low level of residual infection: full-mouth bleeding score (FMBS) ≤20%. Participants showing good levels of compliance were selected. Presence of at least one tooth presenting with gingival recession (GR) requiring subepithelial tissue graft, and with identifiable cement-enamel junction (CEJ).
  • GR exhibiting an identifiable cemento-enamel junction, and absence of plaque or bleeding on probing (BoP) in the sites scheduled for the procedure.
  • GR defects Miller Class I or II without furcation involvement.

排除标准

  • Pregnant or lactating. Smokers and participants with history of alcohol abuse. Periodontal disease.

结局指标

主要结局

Periodontal pocket probing depth (PD)

时间窗: From surgery to December 2023

Measurements of the periodontal pocket depth in millimeters

Keratinized tissue width (KTW)

时间窗: From surgery to December 2023

Measurements of the width of keratinized tissue (gingiva), in millimeters, from the free gingival margin to the mucogingival junction

Gingival recession width (RW)

时间窗: From surgery to December 2023

Measurements of the width of the gingival recession, in millimeters, from the mesial to distal part of the uncovered cementoenamel junction

Gingival recession depth (RD)

时间窗: From surgery to December 2023

Measurements of the depth of the gingival recession, in millimeters, from the cementoenamel junction to the most apical part of the gingival recession

Gingival recession area (RA)

时间窗: From surgery to December 2023

Measurements of the area, in square millimeters, of the gingival recession

次要结局

  • Correlation between initial and late measurements of gingival recession depth (RD)(From surgery to December 2023)
  • Correlation between initial and late measurements of keratinized tissue width (KTW)(From surgery to December 2023)
  • Correlation between initial and late measurements of probing depth (PD)(From surgery to December 2023)
  • Correlation between initial and late measurements of gingival recession width (RW)(From surgery to December 2023)
  • Correlation between initial and late measurements of gingival recession area (RA)(From surgery to December 2023)

研究者

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

CARLO BERTOLDI

Professor

Azienda Ospedaliero-Universitaria di Modena

研究点 (1)

Loading locations...

相似试验