Comparison of Orthodontic Molar Protraction With and Without Adjunctive Surgery

Официальное название

A Prospective, Randomized Clinical Trial to Compare Orthodontic Molar Protraction With and Without Adjunctive Periodontally Accelerated Osteogenic Orthodontic (PAOO) Surgery.

Обзор

This study will compare orthodontic molar protraction with and without adjunctive periodontally accelerated osteogenic orthodontic (PAOO) surgery prior to orthodontic tooth movement. To the investigators' knowledge, this type of molar retraction in adult patients has not been compared with and without the adjunctive use of PAOO for differences in clinical linear tooth movement and patient centered outcomes (discomfort, change in daily activities, satisfaction with esthetic outcomes) in a controlled study.

Подробное описание

Research data and daily clinical observations reveal that molar protraction (forward movement) in adult patients may be prolonged and ideal outcomes may not be achieved with traditional orthodontic tooth movement. One method for enhancing orthodontic tooth movement is the use of surgical access of the local site to initiate a regional tissue reaction to induce trauma, which leads to a limited inflammatory healing process. This process is also known as regional acceleratory phenomenon (RAP), which allows for more rapid bone turnover and has been shown in other protocols to enhance orthodontic tooth movement. While PAOO has been shown to rapidly increase tooth movement, to our knowledge, localized use of PAOO in combination with molar protraction in adults has not been evaluated in a prospective trial for differences in clinical outcomes (tooth movement time, adverse orthodontic outcomes, periodontal and soft tissue defects) and patient-centered outcomes (pain, swelling, change in daily activities, patient assessment of surgical benefit, and patient-assessed esthetics) in a controlled study.

Вмешательства

• Процедура Orthodontic Molar Protraction and PAOO
  Molar Protraction with Orthodontic Tooth Movement and Adjunctive Periodontally Accelerated Osteogenic Orthodontics (PAOO) Surgery was performed on all study sites in this arm in coordination with standard orthodontic molar protraction using traditional bands/brackets and orthodontic wires.
• Процедура Orthodontic Molar Protraction
  Standard orthodontic molar protraction using traditional bands/brackets and orthodontic wires.

Первичные конечные точки

• Linear millimeters of molar tooth movement [Срок оценки: From baseline to 3months]
• Tooth angulation as measured radiographically [Срок оценки: From baseline to 3months]

Вторичные конечные точки (9)

• Periodontal probing depth [Срок оценки: From baseline to 3months]
• Periodontal clinical attachment level [Срок оценки: From baseline to 3months]
• Periodontal width of keratinized tissue [Срок оценки: From baseline to 3months]
• Periodontal width of attached tissue [Срок оценки: From baseline to 3months]
• Practitioner-assessed treatment outcomes [Срок оценки: From baseline to 3months]
• Patient-assessed esthetic outcomes [Срок оценки: From baseline to 3months]
• Patient centered post-operative discomfort assessment [Срок оценки: From baseline to 3months]
• Patient centered global treatment satisfaction [Срок оценки: From baseline to 3months]
• Patient centered alteration of daily activities assessment [Срок оценки: From baseline to 3months]

Критерии участия

Критерии включения

• English speaking
• At least 18 years old
• Must be a patient of the University of Alabama at Birmingham (UAB) Dental School
• Able to read and understand informed consent document
• One or more nonadjacent 1st or 2nd molar teeth that require protraction of ≥ 5 mm in patients undergoing orthodontic tooth movement
• Presence of periodontally healthy, non-carious neighboring teeth, healthy implants or edentulous ridges on either side of the involved site(s)
• No anticipated need for restorative care at the teeth to be treated during the study period.

Критерии исключения

• Non-English speaking
• Less than 18 years old
• Smokers/tobacco users (>10 cigarettes/day)
• Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
• Presence of active periodontal disease, caries, and/or periapical pathology at teeth to be moved orthodontically
• Previous orthodontic therapy involving molar protraction of teeth to be treated
• Previous periodontal surgery at site(s) to be treated

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT03794726 · IRB-300002013 · UAB-Perio

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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