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临床试验/NCT07203872
NCT07203872尚未招募不适用

Adjunctive Inflammation-resolution Therapy in Minimally-invasive Treatment of Deep Periodontal Intrabony Defect: a Pilot Randomised Controlled Trial

Guy's and St Thomas' NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
Probing pocket depth

研究概览

简要总结

The aim of this study is to assess whether and how a mouthwash containing an ingredient that reduces inflammation in combination with a recently developed treatment is more effective at improving advanced gum disease. Advanced gum disease, also called periodontitis, is an inflammation of the gums which results in decrease in bone levels supporting teeth and can result in tooth loss. Minimally invasive non-surgical treatment (MINST) is a type of deep cleaning of teeth which involves removal of plaque beneath the gum margin and reduces inflammation. In this trial we will assess the additional benefits of combining deep cleaning (MINST) with the use of a mouthwash known to have a beneficial effect on tissue healing by helping the body to 'switch off' inflammation in periodontitis. Participants may be part of a control group, where you they be treated by MINST and provided with a placebo mouthwash The placebo mouthwash does not contain the active ingredient which reduces inflammation. Neither the participants nor the investigators can decide or be aware of which mouthwash the participants be given, as this will be determined randomly and the two mouthwash packages look the same.

The duration of the study will be over six months and will consist of a total of seven appointments. The aim of this study is to assess whether we can achieve better outcomes using this mouthwash and the healing of thegums will be assessed clinically. In addition, other parameters such as saliva samples, blood samples and plaque samples will be collected throughout the study, which allows us to examine the healing process in more detail and will help us understand how exactly the combination of MINST and the mouthwash improve healing.

详细描述

This is a pilot randomised controlled trial comparing patients being treated with MINST non-surgical therapy with an adjunctive test or placebo mouthwash. This will be a single centre trial in the Department of Periodontology at Guy's Dental Hospital. Patients will be recruited and treated at this centre as per the inclusion criteria. The primary outcome is PPD reduction at 6 months in test vs control group, and the secondary outcomes are CAL reduction at 6 months, changes in inflammatory/tissue degradation/repair biomarkers in saliva and GCF between baseline and 6 months post-treatment.

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 (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18 to 70
  • •Diagnosis of periodontitis stage III-IV
  • •Presence of at least 1 deep intrabony defect (both PPD and radiographic defects >6mm)
  • •Full-mouth dichotomous plaque score>30%
  • •Willing to voluntarily sign the informed consent.

排除标准

  • •Previous periodontal treatment to the study site within 6 months
  • •Use of systemic antibiotics within 3 months
  • •Weekly regular use of non-steroidal anti-inflammatory drugs
  • •Contributing medical history according to the examining clinician (e.g. diabetes mellitus)
  • •Smoking history (current or within 5 years)
  • •Allergic to any ingredient present in the products used in study.
  • •Presence of systemic diseases, which affects bone and/or connective tissue metabolism
  • •Concurrent participation in other clinical studies.
  • •Pregnant or breastfeeding.

研究组 & 干预措施

MINST + test adjunctive anti-inflammatory mouthwash

Experimental

Patients being treated with MINST non-surgical therapy with an adjunctive test mouthwash (IsoDent Paro Strong)

干预措施: IsoDent Paro Strong (Isodent Ltd. Valtakatu 4 D, 96100 Rovaniemi, Finland) mouthwash (Device)

MINST + placebo mouthwash

Placebo Comparator

Patients being treated with MINST non-surgical therapy with an adjunctive placebo mouthwash

干预措施: Placebo mouthwash (Device)

结局指标

主要结局

Probing pocket depth

时间窗: 6 months

Measure of depth of periodontal pocket taken with periodontal probe (in mm)

次要结局

  • Patient-related outcome measures(6 months)
  • Pocket closure(6 months)
  • Clinical attachment level(6 months)
  • Composite outcome(6 months)
  • Changes in biomarkers(day 1, day 7, 1 month, 3 months, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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