Apically Positioned Flap vs Rolled Flap for Soft Tissue Management During Implant Second-Stage Surgery

Официальное название

Peri-Implant Soft Tissue Management During Second-Stage Surgery With Two Different Flap Techniques: A Randomized Controlled Study

Обзор

Patients are being asked to consider joining a research study that looks at two different ways dentists uncover dental implants during a small gum surgery. To join this study, Patients must have two dental implants that are ready to be uncovered. Both uncovering methods used in this research are normal, safe procedures that dentists already use every day. The purpose of this study is to learn which method helps the gums heal better, stay thicker, and look more natural over time. If patients decide to participate, the dentist will use one method on one implant and the other method on the second implant so we can compare how each implant heals. The study lasts about one year and includes the uncovering surgery plus scheduled follow-up visits. At these visits, the dentist will gently measure your gums, take pictures, take routine dental X-rays, and use a small camera scanner to check how the gum tissue changes. Patients will also be asked to rate any pain or swelling after surgery. Patients may have soreness, swelling, or minor bleeding-these are the same risks patients would have during normal implant care. Patients may or may not personally benefit, but the extra monitoring may help us track the healing closely, and patients' participation can help dentists improve care for future patients. Patients can receive regular implant treatment without joining the study. The goal of this summary is to help you think about the pros and cons and decide what feels right for patients.

Вмешательства

• Процедура Apically Positioned Flap (APF)
  A flap design used during implant second-stage surgery in which a crestal incision with vertical releases is performed, and the flap is repositioned apically and buccally to increase the width of keratinized tissue around the implant.
• Процедура Rolled Flap Technique (RFT)
  A flap design used during implant second-stage surgery in which a pedicled connective tissue portion of the flap is de-epithelialized and rolled toward the buccal aspect to increase peri-implant soft tissue thickness.

Первичные конечные точки

• Change in Keratinized Tissue Width [Срок оценки: Baseline (second-stage surgery) to 12 months after surgery]
• Change in Peri-Implant Mucosal Thickness [Срок оценки: Baseline (second-stage surgery) to 12 months after surgery]

Вторичные конечные точки (8)

• Pink Esthetic Score (PES) [Срок оценки: 3, 6, and 12 months after second-stage surgery]
• Change in Peri-Implant Soft Tissue Volume [Срок оценки: Baseline to 3, 6, and 12 months after second-stage surgery]
• Early Wound Healing Index [Срок оценки: 1 and 2 weeks after second-stage surgery]
• Plaque Index (PI) [Срок оценки: 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery]
• Modified Sulcular Bleeding Index (mSBI) [Срок оценки: 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery]
• Postoperative Pain Score [Срок оценки: 1 and 2 weeks after second-stage surgery]
• Postoperative Swelling Score [Срок оценки: 1 and 2 weeks after second-stage surgery]
• Change in Peri-Implant Bone Level [Срок оценки: Baseline to 12 months after second-stage surgery]

Критерии участия

Критерии включения

• Patients between the ages of 18-80.
• Non-smokers or former smokers with at least a 5-year successful cessation history.
• Patients with normal systemic health (ASA-I) or well-controlled/stable systemic conditions (ASA-II), such as diabetes with HbA1c < 7.0%, no recent acute myocardial infarction or cerebrovascular accidents within 6 months, or any contraindication for periodontal or implant surgery.
• Patients who had, or plan to have, 2 non-adjacent implants of the same system placed under a two-stage implant protocol.
• The diameter discrepancy of the 2 target implants must be less than 1 mm.

Критерии исключения

• Current smokers, or smokers who have quit <5 years prior to study entry.
• Pregnant or lactating women
• Patients with substance or alcohol abuse
• Patients with a history of antiresorptive therapy, head and neck radiotherapy, and chemotherapy for malignant tumors
• Other systemic conditions or medication affecting wound healing.
• Poor plaque control with plaque score > 20%
• Active/untreated odontogenic and periodontal infections
• Implants placed, or planned to be placed, with one-stage implant protocol.
• The diameter discrepancy of the 2 target implants is equal to or greater than 1 mm (≥ 1 mm).
• Implants showing signs of early peri-implant bone loss or infection.
• Severe loss of keratinized tissue (> 50%) at the implant site
• Non-English speaking individuals for studies involving informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07595211 · STUDY20252723

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗