Alternative Gingival De-Epithelialization Techniques

Официальное название

Alternative Gingival De-Epithelialization Techniques: A Randomized Controlled Trial

Обзор

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?

Подробное описание

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.

Вмешательства

• Процедура Surgical Blade
  Using a 15c blade to de-epithelialize the soft tissue extra-orally
• Процедура Mucotome
  Using Megagen Mucotome to de-epithelialize the soft tissue intra-orally
• Процедура Diamond Bur
  Using a surgical diamond bur to de-epithelialize the soft tissue intra-orally
• Процедура Er:YAG Laser
  Using an Er:YAG Laser to de-epithelialize the soft tissue intra-orally

Первичные конечные точки

• Histomorphometric Comparison [Срок оценки: After Day 0 (Baseline surgery)]

Вторичные конечные точки (3)

• Surgical Time [Срок оценки: Day 0 (Baseline Surgery)]
• Patient-reported outcome measures [Срок оценки: Days 1, 7, 14, 21 (Post-operative) after surgery]
• Wound healing [Срок оценки: Days 1, 7, 14, 21 (Post-operative) after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Michigan School of Dentistry — Ann Arbor

Публикации

• 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. PMID 31461778
• 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. PMID 18584934
• 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. PMID 24640997
• 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. PMID 24600654
• 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. PMID 29915931
• 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. PMID 30395825
• 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. PMID 4533490
• 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. PMID 3866056

Идентификаторы

NCT: NCT05947305 · HUM00231789

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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