跳至主要内容
临床试验/NCT07191262
NCT07191262招募中不适用

A Prospective, Randomized Clinical Trial to Compare Post-extraction Use of a Novel Ethylenediaminetetraacetic Acid (EDTA) Post-operative Mouth Rinse and Daily Use EDTA Mouth Rinse and Standard 0.12% Chlorhexidine (CHX) Post-operative Mouth Rinse and Daily Use Essential Oil (EO) Mouth Rinse.

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年3月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
The wound closure after extraction and ridge preservation grafting at 2, 4, and 8, and 12-weeks.

研究概览

简要总结

This study will compare commercially available, commonly used mouth rinses (0.12% chlorhexidine (CHX) vs. Ethylenediaminetetraacetic acid (EDTA)) for immediate post-operative and daily antiseptic use after tooth extraction and ridge preservation grafting followed by daily use of commercially available an essential oil (EO) mouthrinse and EDTA mouthrinse.

详细描述

This investigator-initiated study will compare commercially available, commonly used mouth rinses for post-operative and daily antiseptic use after tooth extraction and bone grafting withing the extraction socket. Current protocols for post-extraction antiseptic use often employ the use of broad-spectrum antimicrobial mouth rinse, commonly 0.12% chlorhexidine (CHX), during the immediate post-operative period when patients are often advised not to perform mechanical oral hygiene (e.g. toothbrushing and interdental cleaning) at the surgical site. Further, approximately 25% of individuals use over-the-counter (OTC) therapeutic mouth rinses daily. Concerns have been raised about the broad-spectrum antimicrobial nature of CHX and the potential for cytotoxic effects from CHX, which can negatively impact both the microbiome and tissue healing at the extraction site. EDTA is a chelating agent that can bind to metal cations and has historically been used in OTC dentifrices (toothpastes) and mouthrinses to reduce calcification of plaque biofilm to reduce calculus (tartar) formation. Recent data evaluating the use of EDTA chelators have expanded dental healthcare professional's understanding of potential mechanisms of action of EDTA to include impacts on initial binding of primary bacterial colonizers within dental plaque biofilms to the dental pellicle.

Specific aims for this project include the prospective comparison of the following outcomes between the groups during the 12-week healing period:

  • Wound closure
  • Plaque index
  • Adverse healing events
  • Patient-reported post-operative outcomes including pain, swelling, change in daily activities, and esthetics
  • Dimensional ridge changes

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
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to read and provide informed consent in English
  • At least 18 years old
  • Established and registered patient of the UAB School of Dentistry
  • Patients presenting with one single rooted tooth determined to need extraction and simultaneous ridge preservation bone grafting for future dental implant placement.
  • Presence of periodontally healthy, non-carious neighboring teeth and/or healthy restored dental implants on either side of the tooth planned for extraction.
  • No anticipated need for surgical and/or endodontic care at teeth adjacent to the proposed surgical site during the study period.

排除标准

  • Non-English speaking
  • Age less than 18 years old or older than 85 years old
  • Smokers/nicotine users (>10 cigarettes or equivalent/day)
  • Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
  • Multiple adjacent teeth require extraction and grafting
  • Absence of adjacent teeth/implants on either side of the tooth to be extracted.
  • Documented or suspected allergy or sensitivity to any study product

研究组 & 干预措施

0.12% CHX and Essential Oil mouthrinse

Active Comparator

0.12% CHX and Essential Oil mouthrinse

干预措施: 0.12% CHX and Essential Oil mouthrinse (Other)

2.6% EDTA and 0.2% EDTA mouth rinse

Experimental

2.6% EDTA and 0.2% EDTA mouth rinse

干预措施: 2.6% EDTA and 0.2% EDTA mouth rinse (Other)

结局指标

主要结局

The wound closure after extraction and ridge preservation grafting at 2, 4, and 8, and 12-weeks.

时间窗: From baseline to 2 weeks, 4 weeks, 8 weeks and 12 weeks postoperatively.

Percentage of wound area closure after extraction and ridge preservation grafting at 2, 4, and 8, and 12 weeks as measured by occlusal photographs in a 1:1 magnification.

次要结局

  • Plaque accumulation at tooth surfaces adjacent to the surgical site(From baseline to 2 weeks, 4 weeks, 8 weeks and 12 weeks postoperatively.)
  • Patient centered outcomes using the Visual Analog Scale (VAS)(From baseline to 2 weeks and 4 weeks postoperatively.)
  • Ridge width and hard tissue dimensional changes after 12-week postoperative healing.(12 weeks)

研究者

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

Maria L. Geisinger, DDS, MS

Professor, Principal Investigator

University of Alabama at Birmingham

研究点 (1)

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