Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis

Официальное название

Impact of Keratinized Mucosa Augmentation Following Non-surgical Therapy on Treatment Outcomes of Peri-implant Mucositis.

Обзор

This study aims to observe the effects of keratinized mucosa width on peri-implant tissues by evaluating clinical and biochemical parameters. The main question it aims to answer is: Would increasing the width of the keratinized mucosa with free gingival graft (FGG) in peri-implant mucositis be beneficial in terms of clinical periodontal parameters and peri-implant crevicular fluid levels of inflammatory cytokines compared to non-surgical therapy alone? Our study consists of 4 groups: Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm) (n=16), peri-implant mucositis group with sufficient keratinized mucosa (n=16), peri-implant mucositis group with insufficient keratinized mucosa (\< 2mm) receiving only non-surgical treatment (n=16), peri-implant mucositis group with insufficient keratinized mucosa receiving FGG in addition to non-surgical treatment (n=16). Clinical and biochemical measurements will be recorded at the baseline, 1st month, 4th month and 7th month of the study. Peri-implant crevicular fluid samples will be collected at baseline, 1st month, 4th month and 7th month. IL-1β, RANKL, OPG levels, and RANKL/OPG ratio will be analyzed from collected samples. Researchers will evaluate the possible benefits of FGG application in addition to non-surgical therapy by comparing the biochemical and clinical changes in areas with and without FGG application in the treatment of peri-implant mucositis.

Вмешательства

• Процедура Non-surgical treatment
  Non-surgical treatment consists of oral hygiene instructions, full mouth supragingival scaling using titanium hand instruments, ultrasonic devices, and subgingival debridement under local anesthesia with titanium curettes and ultrasonic instruments in a single appointment.
• Процедура Free gingival graft
  After adequate local anesthesia is achieved. A horizontal incision is placed mucogingival junction level to prepare the recipient bed. A split-thickness flap is raised without disturbing the periosteum. FGG is obtained from the palate, extending from the mesial surface of the second premolar to the middle of the first molar. The graft is shaped and stitched on the recipient surface.

Первичные конечные точки

• Inflammatory parameter levels in peri-implant crevicular fluid [Срок оценки: Baseline (prior to therapy)]
• Inflammatory parameter levels in peri-implant crevicular fluid [Срок оценки: 1st month]
• Inflammatory parameter levels in peri-implant crevicular fluid [Срок оценки: 4th month]
• Inflammatory parameter levels in peri-implant crevicular fluid [Срок оценки: 7th month]

Вторичные конечные точки (12)

• Plaque index (Silness & Löe, 1964) [Срок оценки: Baseline (prior to therapy)]
• Plaque index (Silness & Löe, 1964) [Срок оценки: 1st month]
• Plaque index (Silness & Löe, 1964) [Срок оценки: 4th month]
• Plaque index (Silness & Löe, 1964) [Срок оценки: 7th month]
• Gingival Index ( Löe & Silness,1963) [Срок оценки: Baseline (prior to therapy)]
• Gingival Index ( Löe & Silness,1963) [Срок оценки: 1st month]
• Gingival Index ( Löe & Silness,1963) [Срок оценки: 4th month]
• Gingival Index ( Löe & Silness,1963) [Срок оценки: 7th month]
• Bleeding on probing (Ainamo & Bay 1975) [Срок оценки: Baseline (prior to therapy)]
• Bleeding on probing (Ainamo & Bay 1975) [Срок оценки: 1st month]
• Bleeding on probing (Ainamo & Bay 1975) [Срок оценки: 4th month]
• Bleeding on probing (Ainamo & Bay 1975) [Срок оценки: 7th month]

Критерии участия

Критерии включения

• Individual dental implants with a fixed prosthetic restoration that has been functional for at least 1 year
• No systemic disease and medication use that may affect periodontal or peri-implanter tissues
• Not receiving periodontal treatment in the last 6 months
• Volunteering to participate in the study

Критерии исключения

• Prosthetic restorations with an excessive contour which do not allow peri-implant pocket measurement
• Being pregnant or breastfeeding,
• Autoimmune and/or inflammatory diseases of the oral cavity,
• Active periodontal disease
• Smokers (≥ 10 cigarettes per day)
• Improperly positioned implants

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Biruni University — Istanbul

Идентификаторы

NCT: NCT06305000 · 2015-KAEK-80-23-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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