An RCT Comparing Tunneled Coronally Advanced Flap (TCAF) and Modified Tunnel Technique (MTUN) in Combination With a Soft Tissue Graft for Single Recession Coverage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- mean root coverage
研究概览
简要总结
Multiple techniques can be used for recession coverage. The most common techniques for single recessions are : tunnel technique (T) and coronally advanced flap (CAF) both combined with a palatal graft to provide sufficient gingival thickness. Recently two modifications have been described in literature, namely the tunneled coronally advanced flap and the modified tunnel. MTUN will function as the control group while people treated with the TCAF technique will function as the test group.
This randomized controlled trial compares MTUN and TCAF to determine which technique provides better root coverage for receding gums at single recession in the premandible. The main question it aims to answer is:
- What is the average root coverage achieved with each technique in the short and long term? This may be clinically relevant because covering gum recession can reduce tooth sensitivity, improve aesthetics and make oral hygiene easier.
Researchers will compare the modified tunnel technique (MTUN = the gum is undermined) with the tunneled coronally advanced flap (TCAF = the gum is undermined, only partially detached and repositioned higher). In both techniques, a small piece of tissue is removed from the palate, which is used to cover the recession. The purpose of the connective tissue graft under the flap/tunnel, is to increase thickness and provide support. Pain associated to the material used to cover the donorsite will be seen as the secondary research question. The site will either be covered by spongostan and multiple stitches or a palatal stent.
Participants will:
- Undergo surgery (MTUN or TCAF, randomly assigned) to cover recessions
- Attend regular check-ups for up to 10 years after surgery
- Keep a postoperative journal (recording medication use, pain levels, tooth sensitivity, etc.)
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years old
- •good oral hygiene
- •presence of one recession in the premandible
- •good general health
排除标准
- •pregnant women (assessed at each visit; if the patient appears pregnant during follow-up, x-rays will not be taken)
研究组 & 干预措施
MTUN + CTG
Modified tunnel with connective tissue graft.
干预措施: modified tunnel with connective tissue graft (Procedure)
TCAF + CTG
Tunneled coronally advanced flap with a connective tissue graft.
干预措施: tunneled coronally advanced flap with connective tissue graft (Procedure)
结局指标
主要结局
mean root coverage
时间窗: From enrollment up to ten years after surgical treatment.
The average percentage of previously exposed tooth root surface that becomes covered by gingival tissue following a root coverage procedure.
次要结局
- width of keratinized tissue(From enrollment up to ten years after surgical treatment.)
- willingness to retreat(From three months post-operative up to two years post-operative.)
- complete root coverage(From enrollment up to ten years after surgical treatment.)
- pocket depth(From enrollment up to ten years after surgical treatment.)
- recession reduction(From enrollment up to ten years after surgical treatment.)
- width of keratinized tissue(From enrollment up to ten years after surgical treatment.)
- gingival thickness(From enrollment up to ten years after surgical treatment.)
- phenotype(From enrollment up to ten years after surgical treatment.)
- treatment time(Only measured during surgery in minutes.)
- post-operative pain at the donor site(From one week post-operative up to three months post-operative.)
- number of analgesics(From one week post-operative up to two weeks post-operative.)
- post-operative pain at the recession site(From one week post-operative up to three months post-operative.)
- willingness to retreat(From three months post-operative up to two years post-operative.)
- score of aesthetic result(From six months post-operative up to ten years post-operative.)
- root sensitivity(From one week pre-operative up to ten years post-operative.)