Clinical Evaluation of Postoperative Healing After Conventional And Laser Assisted Frenectomy Operations
2018年6月9日 更新者：Marmara University
The aim of this randomized controlled parallel-designed study was to evaluate clinical healing and patient comfort after conventional and diode laser assisted frenectomy operations in case of high papillary frenulum attachment.
Forty-eight patients with high papillary frenulum attachments were included in the study.
Patients were randomly divided into three groups; conventional frenectomy operation (Group C), frenectomy operation using diode laser (Group L) and diode laser asissted frenectomy with horizontal incision on the periosteum (Group L+P).
Postoperative pain, difficulty in speaking and eating scores were assessed postoperative 3 hours and 1, 7, 14, 21 and 45 days using Visual Analogue Scale (VAS).
Evaluation of epithelialization of the wound surface was carried out via hydrogen peroxide to the surface using a dental injector at postoperative 7, 14, 21 and 45 days.
Plaque index, gingival index, bleeding on probing and probing depth were assessed at baseline and postoperative 7, 14, 21 and 45 days.
All data were compared between groups and within each group.
研究概览
研究类型
介入性
注册 (实际的)
48
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Systemically healthy, nonsmoker, aged between 18 and 65, high papillary frenulum attachment diagnosed according to Mirko et al (Mirko et al, 1974), not received any periodontal treatment within the last 3 months, presence of at least central, lateral incisors and canines at the upper jaw, and consent to participate in the study.
Exclusion Criteria:
- Any systemic disease that might interfere with the prognosis of periodontal disease (i.e., diabetes mellitus, HIV infection), smoking, antibiotics, anti-inflammatory drugs or any other medication taken within the last 6 months that might affect the outcome of the study, any physical limitations or restrictions that might preclude normal oral hygiene procedures.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Conventional Frenectomy
For the conventional surgery, after application of local infiltration anesthesia of articaine HCL associated with epinephrine 1:100,000, the frenulum was grasped with a straight haemostat inserted into the depth of the vestibule; the tissue adjacent to the upper and lower surfaces of the haemostat was incised with a no.15 scalpel.
After the diamond shaped resected portion of the frenulum was removed with the haemostat, muscle dilatations were excised on the submucosa of the lateral walls of the cavity.
Horizontal incision was made on the periosteum with the help of a scalpel following the procedure.
At the end of the operation, the wound was closed with absorbable sutures (4-0, Pegelak®, Doğsan Turkey).
|
Frenectomy operation performed by surgical blades with suturing.
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实验性的：Diode Laser Frenectomy
For the laser frenectomy, a diode laser device (λ = 810 nm, W: 4, GIGA Cheese II, China) was used to perform the procedure.
The procedure was performed under local infiltration anesthesia with articaine HCL associated with epinephrine 1:100,000.
The frenlum was held by a haemostat inserted into the depth of the vestibule while laser energy was applied to the upper and lower parts of the frenulum adjacent to the haemostat via a fibre tip (400 µm diameter, plain-ended, optical fibre).
The laser was carefully applied to the tissue and care was taken to avoid local necrosis of the periosteum or any bone structure.Following the bleeding control, the wound site was left to secondary healing.
No sutures were necessary after procedure.
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Diode Laser assisted frenectomy operation.
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实验性的：Laser Frenectomy with Incision
For the laser frenectomy, a diode laser device (λ = 810 nm, W: 4, GIGA Cheese II, China) was used to perform the procedure.
The procedure was performed under local infiltration anesthesia with articaine HCL associated with epinephrine 1:100,000.
The frenulum was held by a haemostat inserted into the depth of the vestibule while laser energy was applied to the upper and lower parts of the frenulum adjacent to the haemostat via a fibre tip (400 µm diameter, plain-ended, optical fibre).
The laser was carefully applied to the tissue and care was taken to avoid local necrosis of the periosteum.
Horizontal incision was made on the periosteum with the help of a scalpel, additionally.
No sutures were necessary after procedure.
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Diode Laser assisted frenectomy operation.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative Pain Change
大体时间：Postoperative pain, difficulty during speaking and eating scores were assessed on postoperative 3 hours and 1, 7, 14, 21 and 45 days.
|
Postoperative pain during eating and speaking will be evaluate via visual analog scale (VAS).Visual Analogue Scale (VAS) was used to evaluate pain, discomfort during speaking and chewing.
VAS consisted of a horizontal line with a range of numbers from '0' to '10' of which '0' means 'no pain' and '10' means unbearable pain.
|
Postoperative pain, difficulty during speaking and eating scores were assessed on postoperative 3 hours and 1, 7, 14, 21 and 45 days.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年9月1日
初级完成 (实际的)
2017年10月1日
研究完成 (实际的)
2017年10月1日
研究注册日期
首次提交
2018年3月31日
首先提交符合 QC 标准的
2018年6月9日
首次发布 (实际的)
2018年6月12日
研究记录更新
最后更新发布 (实际的)
2018年6月12日
上次提交的符合 QC 标准的更新
2018年6月9日
最后验证
2018年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.