Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction Without Using Manual Tools: a Clinical Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Subjective Patient's perception of pain
研究概览
简要总结
the aim of this randomized controlled clinical study is to evaluate the efficacy of a new piezoelectric technique for wisdom teeth extraction without using manual tools versus the conventional one.Patients referred to the hospital of Bolzano for wisdom tooth extraction will be randomly divided in two groups. In the test group all the procedure will be performed using piezoelectric instruments, while in the control one conventional manual instruments will be used. Main outcome measures are patient pain and complications, secondary outcome measures are duration of the surgical treatment and soft tissue healing
详细描述
Wisdom teeth extraction can be difficult and patient can suffer post operative swelling and pain. A new piezoelectric technique for wisdom teeth extraction was developed and it showed promising results in terms of surgical effectiveness and patients post operative complications. The aim of the study is to compare the new technique with special designed piezoelectric tools with the traditional one in a randomized controlled way. The same procedures are to be followed for teeth extraction except for the use of a piezoelectric lever in one group and a manual lever in the other one. The study is a mono-center, pragmatic, randomised clinical trial (RCT) of parallel group design. The trial would have one week follow up. All patients referred to the Dental Department of S.Maurizio Hospital (Bolzano, Italy) for the extraction of wisdom teeth are considered eligible for the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sequentially sealed opaque envelopes will be opened by a nurse not involved in the treatment of the patient and a number will be assigned to the patients included in the study. The randomization code will be disclosed at the end of the statistical analysis. The doctor who will evaluate the complications, the duration of the procedure and the healing will be not aware of the type of treatment provided to the patients, nor will be the patients.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients referred for wisdom tooth extraction
- •Patients older than 18 years old and able to sign the informed consent
排除标准
- •General contraindications to surgery.
- •Patients irradiated in the head and neck area.
- •Immunosuppressed or immunocompromised patients.
- •Patients who took or are taking bisphosphonates intravenously.
- •Uncontrolled diabetes
- •Presence of oral pathologies that seriously involved oral mucosa
- •Patients with poor oral hygiene and motivation.
- •Patients with oral pathologies with serious mucosal involvement
- •Pregnancy or lactation.
- •Addiction to alcohol or drugs.
- •Psychiatric problems.
- •Patients with an acute infection inflammation around the tooth to be extracted.
- •Wisdom teeth with roots attached or positioned around the nerve
- •Patients unable to come to the required follow up visits
研究组 & 干预措施
piezoelectric extraction
The flap will be raised using a Piezoelectric elevator, the eventual bone around the third molar crown will be removed with the same piezoelectric lever used for luxation and root extraction. The eventual rizectomy will be performed using a piezoelectric saw.
干预措施: piezoelectric extraction (Procedure)
conventional extraction
The flap will be raised using a manual elevator and the eventual bone around the third molar crown will be removed with a bone bur with a straight handpiece while the eventual rizectomy will be performed using a bone bur. Manual levers will be used for luxation and tooth extraction
干预措施: conventional extraction (Procedure)
结局指标
主要结局
Subjective Patient's perception of pain
时间窗: 7 days
- a visual analogue scale with categorical value from 0 to 10 will be filled by the patient at 6 hours after surgical treatment and every morning in the following 7 days.
次要结局
- Complication(7 days)
- Patient's perception of pain(7 days)
- Duration of the surgical treatment(1 day)
- Healing of soft tissues(7 days)
研究者
Grusovin Maria Gabriella
Principal investigator
Azienda Ospedaliera di Bolzano