Taking Measurements of a Gum Graft Site as it Heals

Официальное название

Dimensional Changes During Early Healing Following Subepithelial Connective Tissue Graft for Root Coverage

Обзор

This is an observational study. The participants in this study will be patients at the Graduate Periodontics Clinic at The Ohio State University who are planning to get a gingival graft to treat their gum recession. Gingival grafts are a common way to treat this recession. The grafting surgery is not part of the study. The main purpose of this study is to better understand the normal healing of a gum graft. In order to do that, the investigators will take different kinds of measurements. 1. It is common for the tissue around the graft to have some swelling after the surgery. The investigators will measure the amount of swelling at different times as the graft heals. This will be done with a digital scanner which is passed over the area. 2. A device which measures blood flow will be used to see how new blood vessels are forming. This is also a device which is only passed over the area, so it is not invasive. 3. Saliva samples will be taken from around the teeth using sterile paper strips. This fluid will be analyzed for substances related to wound healing. 4. Participants will fill out questionnaires about their experience with the graft healing.

Вмешательства

• Процедура Gingival graft surgery to treat gingival recession
  Subepithelial connective tissue grafting (SCTG) is a common procedure for the treatment of gingival recession and involves the autotransplantation of connective tissue from a donor site to the site of recession.

Первичные конечные точки

• Tissue Volume Change [Срок оценки: Immediately prior to surgery; immediately after surgery; Day 2 post-surgery; Day 3 post-surgery; Day 7 post-surgery; Day 14 post-surgery; Day 21 post-surgery]
• Correlation with Graft Exposure [Срок оценки: Immediately prior to surgery; immediately after surgery; Day 2 post-surgery; Day 3 post-surgery; Day 7 post-surgery; Day 14 post-surgery; Day 21 post-surgery]
• Inflammatory Cytokines [Срок оценки: Immediately prior to surgery; immediately after surgery; Day 2 post-surgery; Day 3 post-surgery; Day 7 post-surgery; Day 14 post-surgery; Day 21 post-surgery]
• Microvascular blood flow [Срок оценки: Immediately prior to surgery; immediately after surgery; Day 2 post-surgery; Day 3 post-surgery; Day 7 post-surgery; Day 14 post-surgery; Day 21 post-surgery]
• Post-operative Pain and Analgesic Use [Срок оценки: 2, 3, 7, 14 and 21 days after surgery]

Вторичные конечные точки (1)

• Thickness of the Gingival Flap and Graft [Срок оценки: Day of surgery]

Критерии участия

Критерии включения

• Clinical (oral) Ohio State University College of Dentistry patient, treatment planned for SCTG procedure
• Miller Recession Class I, II, or III
• Teeth; Maxillary or mandibular incisors, canines, pre-molars
• Gingival Index ≤ 1
• Plaque Index ≤ 1
• Able and willing to provide informed consent
• Able and willing to complete questionnaire

Критерии исключения

• Carious lesions on the tooth selected for surgical root coverage
• Taking any medications affecting the gingiva and/or oral mucosa: phenytoin, calcium channel blockers , cyclosporin A, immunostimulants/ immunomodulators
• Quantitative and/or qualitative defects on host inflammatory cells
• Organ transplant(s)
• Type I or II diabetes
• Currently pregnant or lactating
• Usage of smokeless tobacco
• Physical/mental handicap which can interfere with adequate oral hygiene performance

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• The Ohio State University Graduate Periodontics Clinic — Columbus

Идентификаторы

NCT: NCT07386457 · 2025H0007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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