Clinical Comparison of Frenotomy and Frenectomy Surgical Techniques for Management of High Frenum Attachment in Adult Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Rebound / Relapse.
研究概览
简要总结
The goal of this randomized clinical trial is to compare frenotomy to frenectomy surgical techniques in the management of high frenum attachment in adults. The main questions it aims to answer are:
- Does Frenotomy procedure have a lower relapse rate compared to frenectomy?
- Does Frenotomy procedure result in fewer postoperative complications? Participants will be divided into two groups. The intervention group will involve frenotomy procedure for participants and will be compared to the traditional frenectomy procedure in the comparator group. The level of the frenum will be measured at baseline and after 6 months. Pain scores will be recorded by the participants during the first week.
详细描述
Frenum is a triangular thin folded mucus membrane with underlying connective tissue and muscular fibers that attaches the lips and cheeks with alveolar mucosa enhancing the stability of the lip (Newman et al., 2020).
High frenum attachment can have numerous negative effects when highly attached close to the gingival margin including gingival recession, papilla loss, and obliteration of the sulcus, which might enhance plaque accumulation indirectly by hindering tooth brushing. It may also be responsible for midline diastema (Miller, 1985).
According to Mirko et al. (1974), there are four different types of labial frenal attachments: mucosal, gingival, papillary, and papilla piercing. The mucosal form is the most common and predominates in the mandible (Jańczuk & Banach, 1980).
Frenectomy procedure involves the complete removal of the frenum along with its attachment to the underlying bone. Frenotomy procedure is the incision and relocation of the frenal attachments to a more apical level (Dibart & Karima, 2008). However, this procedure is not well-documented in the literature and little is known about its expected relapse rates.
The rationale for conducting the research:
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be unaware of the recruitment group. The allocation sequence will be contained within sequentially numbered, opaque, sealed packets that the patients will pull. According to the randomization table, the written number on the paper will allocate the patient to the intervention or control group.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults with active highly attached maxillary/mandibular labial frenum.
- •Systemically healthy
- •Non-smokers
- •Gingival and plaque index <10%
排除标准
- •Poor oral hygiene.
- •Any systemic diseases or medications that delay wound healing.
- •Pregnant or lactating females
- •Previous frenal procedures.
结局指标
主要结局
Rebound / Relapse.
时间窗: 6 months
The level of the frenum will be measured at baseline and follow-up using William's graduated periodontal probe. The incisal edge will be assigned as a reference point at baseline to measure the frenum level before and after the procedure and identify the change in level.
次要结局
- Postoperative pain(1 week)
研究者
Nada Zazou
Lecturer of Periodontology
October University for Modern Sciences and Arts