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临床试验/NCT03757260
NCT03757260Unknown不适用

The Efficacy of Adjunctive Antimicrobial Photodynamic Therapy for Residual Pockets in Previously Surgically Treated Teeth: a Randomized Clinical Trial.

University of Manitoba2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年1月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
试验地点
2
主要终点
Change in bleeding on probing (BOP)

研究概览

简要总结

Traditionally, periodontal gum surgery has been used as a method to gain access to inflamed periodontal pockets around teeth. The outcome of these surgeries, however, is not always successful as there can be recurrence of inflammation and disease. The objective of this study is to assess the effectiveness of antimicrobial photodynamic therapy as an adjunct to mechanical debridement of residual periodontal pockets in patients having undergone periodontal surgery. Pocket probing depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI) will be evaluated at all sites as measures of inflammation and disease resolution.

详细描述

A single-center, randomized, double-blind, longitudinal study will take place over 12 months. Twenty-eight systemically healthy patients (i.e. absence of uncontrolled diabetes mellitus, cancer, HIV, bone metabolic diseases, or disorders that compromise wound healing) enrolled in a supportive periodontal therapy program and patients at the University of Manitoba Graduate Periodontics Clinic, with at least one surgically treated site with a residual pocket probing depth of ≥ 5mm and bleeding upon probing and having signed the informed consent will be accepted into the study. PPD, CAL, BOP, and PI will be evaluated at these sites. A selected participant will have a full mouth periodontal charting completed prior to baseline measurements as part of their maintenance program.

Once selected the patient will see two clinicians: the examiner (hygienist) and operator (resident).

The examiner records the data (PPD, CAL, BOP, PI) of the entire dentition including the selected tooth or teeth, and provides preliminary hygiene treatment; the operator delivers the test treatments.

The treatment assignments are concealed to the patient and the examiner. The operator is unaware of previously recorded data except for pocket depth measurements and is not involved in the post-treatment evaluations (3,6,12 months). At 12 months, a full mouth re-evaluation will be completed by the examiner as part of the patient's maintenance program.

In the first visit, the examiner records the pocket probing depth, clinical attachment level, presence of bleeding on probing, and plaque index at six sites on involved teeth. Thorough scaling and root planing is performed under local anesthesia using periodontal curettes (Gracey, Hu-Friedy, USA) and an ultrasonic device (Piezo, Ultradent, USA). Once complete, the operator takes over. The patients are then randomly assigned to test or control groups by a computer-generated table. The protocol may be: A, the laser is activated during treatments with methylene blue; B, the laser is never activated during treatments with saline solution.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

Once selected the patient will see two clinicians: the examiner (hygienist) and operator (resident).

The examiner records the data (PPD, CAL, BOP, PI) of the teeth, and provides preliminary hygiene treatment; the operator delivers the test treatments.

The treatment assignments are concealed to the patient and the examiner. The operator is unaware of previously recorded data except for pocket depth measurements and is not involved in the post-treatment evaluations (3,6,12 months)

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

  • Systemically healthy
  • Enrolled in a supportive periodontal therapy program and a patient at the University of Manitoba Graduate Periodontics Clinic
  • At least one surgically treated periodontal site with a residual pocket probing depth of ≥ 5mm and bleeding upon probing
  • Completed informed consent

排除标准

  • Patients with uncontrolled diabetes mellitus
  • Patients with cancer
  • Patients with HIV
  • Patients with bone metabolic diseases
  • Patients with disorders that compromise wound healing
  • Patients undergoing radiation or immunosuppressive therapy
  • Pregnancy or lactation
  • Have had antibiotics therapy within the last three months
  • Confirmed or suspected intolerance to methylene blue
  • Any physical limitations or restrictions that might preclude normal oral hygiene procedures

结局指标

主要结局

Change in bleeding on probing (BOP)

时间窗: Initial, 3 months, 6 months, 12 months.

Change in the presence of bleeding upon probing on individual tooth surfaces at 3 months, 6 months, and 12 months compared to the initial measure.

次要结局

  • Change of clinical attachment level (CAL)(Initial, 3 months, 6 months, 12 months.)
  • Change in pocket probing depth (PPD)(Initial, 3 months, 6 months, 12 months.)
  • Change of plaque index (PI)(Initial, 3 months, 6 months, 12 months.)

研究者

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

Javier Cabrales

Principal Investigator

University of Manitoba

研究点 (2)

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