替代牙龈去上皮技术
替代牙龈去上皮技术：随机对照试验
The goal of this clinical trial is to compare different de-epithelialization methods in patients undergoing soft tissue augmentation surgery. The main questions it aims to answer are:
• Which technique is superior for de-epithelialization in terms of remaining epithelium, wound healing of the donor site, and clinical outcomes?
研究概览
地位
详细说明
Participants will be randomly assigned to one of four surgical techniques during their surgical procedure and the wound site will be assessed on post-operative days 1, 7, 14, and 21.
Researchers will compare the use of mucotome, Er:YAG laser, surgical diamond bur, or blade to observe patterns of wound healing and assess if one method is superior in terms of removing the epithelium.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109
- University of Michigan School of Dentistry
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) Physical Status Classification I or II
- Subjects undergoing periodontal surgical procedures that involve harvesting of soft tissue samples, who have a treatment plan including the use or removal of keratinized mucosa or subepithelial connective tissue that will not require additional anesthesia for sample collection
- Adequate physical and mental health to undergo routine dental treatment
- Ability and willingness to follow instructions related to the study procedures
Exclusion Criteria:
- Poorly controlled diabetes, defined as HbA1c >/= 7.0
- Autoimmune or inflammatory conditions such as systemic lupus erythematous, rheumatoid arthritis.
- Pregnant women or nursing mothers, or unsure of pregnancy status (self-reported)
- Severe hematologic disorders, such as leukemia or hemophilia
- Subjects on anticoagulant or antiplatelet therapy
- Local or systemic infection that may interfere with healing
- Hepatic or renal diseases
- Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy
- History of antibiotic or immunosuppressant use in the last 3 months
- Subjects on concomitant drug therapy for systemic conditions that may affect outcomes of the study
- Current smokers (CDC definition): heavy smokers: subjects who have smoked >10 cigarettes per day within 6 months of study onset, and have smoked >100 cigarettes in their lifetime
学习计划
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Surgical Blade
A surgical blade will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery. |
Using a 15c blade to de-epithelialize the soft tissue extra-orally |
|
实验性的：Mucotome
A mucotome will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery. |
Using Megagen Mucotome to de-epithelialize the soft tissue intra-orally |
|
实验性的：Diamond Bur
A diamond bur will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery. |
Using a surgical diamond bur to de-epithelialize the soft tissue intra-orally |
|
实验性的：Er:YAG Laser
A dental laser will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery. |
Using an Er:YAG Laser to de-epithelialize the soft tissue intra-orally |
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 |
|---|---|---|
|
Histomorphometric Comparison
大体时间：After Day 0 (Baseline surgery)
|
Histomorphometric evaluation of the relative proportion of epithelial tissue remnants (percentage) after de-epithelialization of the CTG |
After Day 0 (Baseline surgery)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Surgical Time
大体时间：Day 0 (Baseline Surgery)
|
Time spent removing the epithelium (in minutes) |
Day 0 (Baseline Surgery)
|
|
Patient-reported outcome measures
大体时间：Days 1, 7, 14, 21 (Post-operative) after surgery
|
Patient-reported outcome measures regarding pain and discomfort after the procedure using a line scale (from no pain to worst pain imaginable), box scale (ranging from 0-10 with 0 being no pain and 10 being worst pain imaginable), and a verbal rating scale (no pain, slightly painful, moderately painful, very painful, extremely painful). The number of analgesics (along with dosage) taken during the post-operative period will be recorded. |
Days 1, 7, 14, 21 (Post-operative) after surgery
|
|
Wound healing
大体时间：Days 1, 7, 14, 21 (Post-operative) after surgery
|
Wound healing comparisons using a clinical healing index (CHI) developed by Pippi et al 2015 will be completed. The possible total score is 7 (ideal score demonstrating ideal healing = 0), with scores for each section being dichotomous (0 or 1). Parameters related to clinical inspection include: mucosal color, granulation tissue, epithelialization degree, and swelling. Palpation parameters include bleeding, pain, and suppuration. |
Days 1, 7, 14, 21 (Post-operative) after surgery
|
合作者和调查者
调查人员
- 首席研究员：Sandra Stuhr, DMD, MS、University of Michigan
出版物和有用的链接
一般刊物
- Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.
- Langer B, Langer L. Subepithelial connective tissue graft technique for root coverage. J Periodontol. 1985 Dec;56(12):715-20. doi: 10.1902/jop.1985.56.12.715.
- Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects? J Dent. 2008 Sep;36(9):659-71. doi: 10.1016/j.jdent.2008.05.007. Epub 2008 Jun 26.
- Zucchelli G, Amore C, Sforza NM, Montebugnoli L, De Sanctis M. Bilaminar techniques for the treatment of recession-type defects. A comparative clinical study. J Clin Periodontol. 2003 Oct;30(10):862-70. doi: 10.1034/j.1600-051x.2003.00397.x.
- Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.
- Bosco AF, Bosco JM. An alternative technique to the harvesting of a connective tissue graft from a thin palate: enhanced wound healing. Int J Periodontics Restorative Dent. 2007 Apr;27(2):133-9.
- El-Kholey KE. Efficacy and safety of a diode laser in second-stage implant surgery: a comparative study. Int J Oral Maxillofac Surg. 2014 May;43(5):633-8. doi: 10.1016/j.ijom.2013.10.003. Epub 2013 Nov 7.
- Zucchelli G, Tavelli L, McGuire MK, Rasperini G, Feinberg SE, Wang HL, Giannobile WV. Autogenous soft tissue grafting for periodontal and peri-implant plastic surgical reconstruction. J Periodontol. 2020 Jan;91(1):9-16. doi: 10.1002/JPER.19-0350. Epub 2019 Oct 6.
- Dellavia C, Ricci G, Pettinari L, Allievi C, Grizzi F, Gagliano N. Human palatal and tuberosity mucosa as donor sites for ridge augmentation. Int J Periodontics Restorative Dent. 2014 Mar-Apr;34(2):179-86. doi: 10.11607/prd.1929.
- Sanz-Martin I, Rojo E, Maldonado E, Stroppa G, Nart J, Sanz M. Structural and histological differences between connective tissue grafts harvested from the lateral palatal mucosa or from the tuberosity area. Clin Oral Investig. 2019 Feb;23(2):957-964. doi: 10.1007/s00784-018-2516-9. Epub 2018 Jun 18.
- Tavelli L, Barootchi S, Ravida A, Oh TJ, Wang HL. What Is the Safety Zone for Palatal Soft Tissue Graft Harvesting Based on the Locations of the Greater Palatine Artery and Foramen? A Systematic Review. J Oral Maxillofac Surg. 2019 Feb;77(2):271.e1-271.e9. doi: 10.1016/j.joms.2018.10.002. Epub 2018 Oct 11.
- Edel A. Clinical evaluation of free connective tissue grafts used to increase the width of keratinised gingiva. J Clin Periodontol. 1974;1(4):185-96. doi: 10.1111/j.1600-051x.1974.tb01257.x. No abstract available.
- Harris RJ. The connective tissue and partial thickness double pedicle graft: a predictable method of obtaining root coverage. J Periodontol. 1992 May;63(5):477-86. doi: 10.1902/jop.1992.63.5.477.
- Carranza N, Rojas MA. Bilaminar Palatal Connective Tissue Grafts Obtained With the Modified Double Blade Harvesting Technique: Technical Description and Case Series. Clin Adv Periodontics. 2020 Dec;10(4):186-194. doi: 10.1002/cap.10124. Epub 2020 Sep 20.
- Wei PC, Geivelis M. A gingival cul-de-sac following a root coverage procedure with a subepithelial connective tissue submerged graft. J Periodontol. 2003 Sep;74(9):1376-80. doi: 10.1902/jop.2003.74.9.1376.
- Tavelli L, Ravida A, Lin GH, Del Amo FS, Tattan M, Wang HL. Comparison between Subepithelial Connective Tissue Graft and De-epithelialized Gingival Graft: A systematic review and a meta-analysis. J Int Acad Periodontol. 2019 Apr 1;21(2):82-96.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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