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Comparison Between Periodontal Effects of Fixed and Vacuum-Formed Retainers

12 июня 2026 г. обновлено: Toka Mustafa Saad Mohamed, Cairo University

Clinical Evaluation of Gingival and Periodontal Health of Lower Anterior Teeth With Fixed Retainer Versus Removable Retainer: A Randomized Clinical Trial.

One of the most crucial aspects of orthodontic therapy is retention, which is required to prevent orthodontic relapse . There are two main types of retainers, removable retainer which depends on patient compliance to achieve proper results, and fixed retainer which can overcome the problem of patient compliance, but with using it there is higher risk of plaque accumulation and the process of brushing teeth becomes more complex. However, it is not known whether this necessarily leads to worsening of periodontal outcomes . The increasing use of permanent retainers and their requirement for continuous wear highlight the importance of evaluating their impact on the periodontal health but there is conflicting data available right now on how orthodontic retainers affect periodontal diseases

Обзор исследования

Статус

Активный, не рекрутирующий

Подробное описание

The purpose of this research is to compare the effect between fixed and removable retainer on periodontium as the current evidence on how these appliances affect periodontal health is still lacking significantly Orthodontic treatment plays an important role in enhancing the function, esthetics and overall well-being of patients. One of the most important elements of treatment is the retention phase. There are two main types of retainers that can be used in the retention phase either fixed or removable.

At first banded fixed appliances were used as retainers , then in 1919 Hawly introduced removable retainers , then in 1973 Kneirim RW. introduced the first bonded retainer as enamel etching and modern adhesive systems facilitated the use of bonded retention .

The most widely used removable retainer is the Hawley appliance, which is made of wire and acrylic resin.

In 1971 Ponitz introduced fiber reinforced retainer which is less expensive, with better esthetics and easy to clean but it is not dimensionally stable and more prone to wearing.

The duration of the retention phase frequently exceeds that of the active treatment. In many cases, orthodontists even propose lifetime retention.

Removable retainers depend greatly on patient compliance so fixed compliance-free retainers were introduced but they cause more plaque accumulation and make the process of brushing teeth more complex, also there is conflicting data about their effect on periodontal health Artun was one of the first orthodontists to investigate the periodontal effect of fixed retainers. He found out that more plaque accumulation occurred with fixed retainers, but he suggested that plaque and calculus accumulation gingival to the retainer wire might not cause serious damage to the periodontium According to the most recent Cochrane review concerning this matter, most of the studies found no difference in periodontal measurements between the two types of retainers but one study found that the lower fixed retainer group had considerably more periodontal pocketing and bleeding on probing than the full-time lower removable retainer . Nevertheless, it is important to exercise caution when interpreting this periodontal pocketing outcome because the two groups were not similar at debonding, with four times as many participants in the fixed retainer group

The most recent systematic reviews also concluded that the available evidence on this topic is inconclusive and that more research is needed which would help in choosing the suitable type of retainer for each patient as there are no specific guidelines for choosing one type of retainer over the other for each patient. But they concluded that fixed retainers are compatible with periodontal health, or at least not related to severe detrimental effects on the periodontium.

It must also be taken in consideration several factors when interpreting the results of effect of fixed retainers on periodontal health like Hawthrone effect, limited follow up period and selection bias as most studies select people with good periodontal health .

The concept of periodontal health was derived from Chapple et al. and is basically defined as having no clinical loss of attachment, limited bleeding on probing (< 10%), and no significantly elevated probing depths (≤ 3 mm)

Тип исследования

Интервенционный

Регистрация (Действительный)

46

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

      • Cairo, Египет
        • Faculty of Dentistry Cairo University

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок
  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  • Minimal age of twelve years.
  • Presence of all mandibular anterior teeth from canine to canine.
  • Completion of orthodontic multi-bracket treatment with the requirement of retention of the mandibular anterior teeth.
  • Periodontal screening index ≤ 2 [18].
  • Participation in all study visits.

Exclusion Criteria:

  • Systemic disease potentially affecting the study outcome.
  • Conditions requiring antibiotic prophylaxis for clinical measurements that trigger transitory bacteremia.
  • Pregnant females.
  • Chronic use of medications affecting the study outcome.
  • Patients with active periodontal disease

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: intervention group ( fixed retainer group)
  • At first, medical and dental histories will be taken from the patients then extra- and intra-oral examinations will follow.
  • Brackets are removed using a plier at the end of active orthodontic treatment.
  • Excess adhesive material is removed using finishing stones and rubber polishing kit.
  • Polishing the teeth before placement of retainer. For the fixed retainer group, it will be fabricated from a stainless-steel alloy and applied to each lingual tooth surface from one mandibular canine to the contralateral canine.

The patients' teeth surfaces will then be prepared using 37% phosphoric acid etchant gel for 30 seconds, rinsed and dried with oil-free compressed air for 10 seconds. After drying the enamel surfaces, a bonding agent will be applied using a micro-brush, spread using oil-free compressed air followed by the application of the adhesive material and placement of the fixed retainer. After light curing excess adhesive material will be removed.

Patients are given oral hygiene instructions during retention period , frequent follow up visits with patients
Активный компаратор: control group ( vacuum retainer group)

At first, medical and dental histories will be taken from the patients then extra- and intra-oral examinations will follow.

  • Brackets are removed using a plier at the end of active orthodontic treatment.
  • Excess adhesive material is removed using finishing stones and rubber polishing kit.
  • Polishing the teeth before placement of retainer.

For the removable retainer group the mandibular removable retainers will be fabricated using thick thermoplastic vacuum-formed sheets, patients will be instructed to wear them full- time.

Patients are given oral hygiene instructions during retention period , frequent follow up visits with the patients

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Probing depth
Временное ограничение: immediately after debonding and after 6 months
Assessment of periodontal health using Periodontal probing depth Probing depth is measured in mms using periodontal probe, in a healthy periodontium pocket typically measures between 1 to 3 millimeters in depth
immediately after debonding and after 6 months
Bleeding on probing
Временное ограничение: immediately after debonding and after 6 months
Bleeding on probing is a 4 point scale Score 0: No bleeding No bleeding when you probe the gingival sulcus/pocket Score 1: Bleeding on probing Bleeding occurs after probing, usually within 10-30 seconds ,Mild bleeding at the gingival margin Score 2: Bleeding + profuse Bleeding is immediate, profuse, and often fills the sulcus, Or bleeding flows from the sulcus Score 3: Spontaneous bleeding, Bleeding occurs without any probing Seen before you even touch the tissue
immediately after debonding and after 6 months
gingival recession
Временное ограничение: immediately after debonding and after 6 months
Loss of clinical attachment level is measured as the distance in millimeters between the bottom of the pocket and the cementoenamel junction. Based on the extent of attachment loss, it can be categorized as light (1-2 mm), moderate (3-4 mm), or severe (5 mm or more) loss of clinical attachment.
immediately after debonding and after 6 months
Gingival index
Временное ограничение: immediately after debonding and after 6 months
Gingival index is a 4-point scale in which scale 0 is healthy periodontium and scale 3 is severe inflammation.
immediately after debonding and after 6 months
plaque index
Временное ограничение: immediately after debonding and after 6 months
Plaque index is a 4-point scale in which scale 0 indicates the absence of plaque at the free gingival margin after drying, and scale 3 represents an abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface, including the interdental area
immediately after debonding and after 6 months

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
patient satisfaction
Временное ограничение: After 6 months
Assessment of patient satisfaction using questionnaire.
After 6 months

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

21 ноября 2025 г.

Первичное завершение (Оцененный)

30 июня 2027 г.

Завершение исследования (Оцененный)

31 декабря 2027 г.

Даты регистрации исследования

Первый отправленный

9 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

12 июня 2026 г.

Первый опубликованный (Действительный)

16 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

16 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

12 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • ??1125

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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