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Prefabricated CAD/CAM PEEK Crowns For Primary Molars Restoration

28 мая 2026 г. обновлено: Arab International University

Evaluation of Minimally Prepared CAD/CAM Polyetheretherketone (PEEK) Crowns Efficacy in Restoring Primary Molars

This Split-mouth randomized clinical trial aims to evaluate CAD/CAM prefabricated Polyether ether ketone crowns for primary molars restoration after pulpotomy compared to Stainless steel crowns Over follow-up periods of 3, 6, and 12 months, the sample included 60 children aged 5-9 years who had bilateral mandibular second primary molars.

Each child received a pulpotomy treatment followed by the placement of a stainless steel crown on one side and a PEEK crown on the contralateral side, distributed randomly.

Clinical parameters were subsequently evaluated during the three follow-up periods, including the gingival index, plaque index, bleeding on probing index, restoration retention and integrity, marginal adaptation, color stability, and both parental and child satisfaction.

Обзор исследования

Подробное описание

Interest in the esthetic aspect of pediatric dental treatment has increased among both children and parents, as children's self-perception is strongly influenced by the appearance of their teeth from an early age. Most esthetic restorative options require extensive tooth preparation compared with stainless steel crowns (SSCs). However, only limited studies have investigated conservative esthetic alternatives for primary molars.

This randomized controlled clinical trial aimed to evaluate the clinical effectiveness of CAD-CAM prefabricated esthetic PEEK crowns compared with stainless steel crowns (SSCs) in restoring primary mandibular second molars after pulpotomy. Clinical performance was assessed according to restoration retention and integrity, gingival health, plaque accumulation, bleeding on probing, marginal adaptation, color stability, and child/parent satisfaction over follow-up periods of 3, 6, and 12 months.

The sample was randomly allocated using the website: randomization.com

A total crowns were randomly distributed into four groups (n=20 per group):

(A): Prefabricated CAD/CAM PEEK crowns with 0.2 mm thickness (B): Prefabricated CAD/CAM PEEK crowns with 0.4 mm thickness (C): CAD/CAM fabricated PEEK crowns prepared according to NuSmile recommendations (D): Stainless steel crowns (SSC). The study included healthy, cooperative children aged 5-9 years requiring pulpotomy treatment for mandibular second primary.

Clinical Procedure

Clinical and radiographic examinations are performed to confirm the indication for pulpotomy treatment, followed by completion of the study form. Local anesthesia and rubber dam isolation are carried out, and pulpotomy is performed according to the conventional technique described by Dean (2016). The tooth is then restored with glass ionomer cement.

After cement setting, conservative tooth preparation is performed using diamond burs with 1-2 mm occlusal reduction. For Groups I, II, and IV, proximal reduction is completed with minimal preparation. In Group III, tooth preparation follows NuSmile recommendations, including occlusal reduction, proximal opening, crown reduction, and a 1 mm subgingival finish line.

For Groups I, II, and IV, the appropriate crown size is selected, checked for marginal adaptation and proximal contacts, then cemented using Fuji I glass ionomer cement. Excess cement is removed using a dental explorer and dental floss.

For the CAD/CAM fabricated PEEK group, a silicone impression is taken and scanned digitally. Crowns are designed using Exocad software and fabricated with CAD-CAM technology. After polishing and internal surface conditioning with aluminum oxide particles, the crown is tried in, cemented with Fuji I glass ionomer cement, and excess cement is removed.

Clinical parameters are evaluated immediately after crown cementation for directly measurable baseline variables and during the three follow-up periods (after 3, 6, 12 months), including the gingival index, plaque index, bleeding on probing index, restoration retention and integrity, marginal adaptation, color stability, and both parental and child satisfaction.

Тип исследования

Интервенционный

Регистрация (Оцененный)

60

Фаза

  • Непригодный

Контакты и местонахождение

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

Места учебы

      • Damascus, Сирия
        • School of Dental Medicine

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

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  1. Healthy children aged 5-9 years.
  2. Children requiring pulpotomy of mandibular second primary molars.
  3. Cooperative children rated as positive or definitely positive on the Frankl behavior scale.
  4. No acute or chronic abscess at the anesthesia site.

Exclusion Criteria:

  1. Root resorption exceeding the apical third.
  2. Non-restorable teeth.
  3. Presence of swelling, fistula, or acute or chronic pulpitis.

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: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Назначение кроссовера
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Prefabricated PEEK crowns of 0.2 mm thickness
Minimally prepared teeth restored with prefabricated PEEK crowns of 0.2 mm wall thickness.
The pulpotomized molar assigned to experimental group will be received A Polyether ether ketone prefabricated crown with 0.2mm thickness on one side of mandibular arch, and the other side will be received a Stainless steel crown as control group.
Экспериментальный: Prefabricated PEEK crowns of 0.4 mm wall thickness
Minimally prepared teeth restored with prefabricated PEEK crowns of 0.4 mm wall thickness.
The pulpotomized molar assigned to experimental group will be received A Polyether ether ketone prefabricated crown with 0.4mm thickness on one side of mandibular arch, and the other side will be received a Stainless steel crown as control group.
Экспериментальный: CAD/CAM-fabricated PEEK crowns
Teeth receiving comprehensive preparation and restored with CAD/CAM-fabricated PEEK crowns following the NuSmile preparation protocol.
The pulpotomized molar assigned to experimental group will be received A CAD/CAM fabricated Polyether ether ketone crown on one side of mandibular arch, and the other side will be received a Stainless steel crown as control group.
Активный компаратор: Stainless steel crowns
Minimally prepared teeth restored with prefabricated stainless steel crowns, as the positive control group.
The pulpotomized molar assigned to control group will be received a Stainless steel crown as control group on one side of mandibular arch, and the other side will be received one of the arm 1, 2, or 3

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Gingival Index
Временное ограничение: Baseline, 3 months, 6 months, and 12 months postoperatively

0 = No gingival inflammation.

  1. = Mild inflammation with slight changes in color and texture affecting part of the marginal gingiva or papilla.
  2. = Mild inflammation with changes in color and texture involving the entire marginal gingiva or papilla.
  3. = Moderate gingival inflammation with obvious redness, surface glazing, edema, and/or enlargement of the marginal gingiva or papilla.
  4. = Severe gingival inflammation with marked redness, edema and/or enlargement of the marginal gingiva or papilla, spontaneous bleeding, and ulceration.
Baseline, 3 months, 6 months, and 12 months postoperatively
Plaque Index
Временное ограничение: Baseline, 3 months, 6 months, and 12 months postoperatively

0 = No plaque accumulation around the gingival margin.

  1. = Slight plaque accumulation detected only by passing a probe.
  2. = Moderate plaque accumulation visible to the naked eye.
  3. = Heavy plaque accumulation on the crown surface, gingiva, and interdental areas.
Baseline, 3 months, 6 months, and 12 months postoperatively
Bleeding on Probing
Временное ограничение: Baseline, 3 months, 6 months, and 12 months postoperatively

Bleeding on probing is assessed using a Williams periodontal probe inserted into the gingival sulcus around each crowned tooth. Four sites (mesial, distal, buccal, and lingual) are examined, and bleeding is evaluated 10 seconds after probing as follows:

(-) No bleeding. (+) Bleeding present.

Baseline, 3 months, 6 months, and 12 months postoperatively
Wong-Baker Faces Scale
Временное ограничение: Baseline, 3 months, 6 months, 12 months postoperatively

A Wong-Baker Faces Scale consisting of six expressive faces is used, ranging from "no hurts" to "hurts worst," to facilitate the child's selection of the appropriate face. The scale ranges from 0 to 10.

The child is given a questionnaire displaying the faces immediately after crown placement and is asked to choose the face that best represents their feeling at that moment. The child indicates the selected face by pointing to it, and the response is recorded in the study form.

Baseline, 3 months, 6 months, 12 months postoperatively

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Color Stability
Временное ограничение: 3 months, 6 months, 12 months postoperatively

Color stability is assessed using a shade guide as a reference standard. The crown color is compared with the shade guide at each follow-up visit (3, 6, and 12 months) according to the following criteria:

0 = No color change.

  1. = Slight change from the original color.
  2. = Unacceptable color change.
3 months, 6 months, 12 months postoperatively
Restoration retention and integrity
Временное ограничение: 3 months, 6 months, 12 months postoperatively

The clinical condition of the crown is evaluated during follow-up visits according to the following criteria:

0 = No visible fracture.

  1. = Minor crown fracture that is repairable.
  2. = Major crown fracture that can still be repaired.
  3. = Crown loss and exclusion from the study sample.
3 months, 6 months, 12 months postoperatively
Marginal Adaptation
Временное ограничение: 3 months, 6 months, 12 months postoperatively

Marginal adaptation discrepancies were evaluated clinically using a sharp explorer and direct visual examination under dental operating light According to the modified United States Public Health Service (USPHS) criteria; (A): An Alpha grade represented a clinically ideal restoration with excellent marginal adaptation, no detectable gap on exploratory examination.

(B): A Bravo grade indicated a clinically acceptable restoration with a slight marginal discrepancy detectable by an explorer, but without dentin exposure.

(C): A Charlie grade was assigned to restorations that were clinically unacceptable due to a definite marginal gap, with exposed dentin.

(D): A Delta grade denotes the worst clinical condition, characterized by gross marginal failure, loss of retention, or other major defects, for which complete replacement of the restoration is required.

3 months, 6 months, 12 months postoperatively
Patient/Parent Satisfaction
Временное ограничение: 3 months, 6 months, 12 months postoperatively

The child and one parent are asked about their satisfaction with the crowns regarding esthetics and function, and the responses are recorded in the patient form. Evaluation is performed as follows:

  1. = Completely satisfied with both esthetic and functional outcomes.
  2. = Satisfied with esthetic and functional outcomes with a minor remark.
  3. = Minor criticism without negative clinical effects or esthetic defects.
  4. = Desire for improvement in esthetic and functional aspects.
  5. = Completely dissatisfied.
3 months, 6 months, 12 months postoperatively

Соавторы и исследователи

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

Соавторы

Следователи

  • Главный следователь: Bushra Munzer Shamma, MSc, DDS., Damascus University
  • Учебный стул: Mohannad Laflouf, PhD, MSc, DDS., Damascus University
  • Директор по исследованиям: Saleh Al Kurdi, PhD, MSc, DDS., Arab International University

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

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)

2 апреля 2024 г.

Первичное завершение (Действительный)

10 декабря 2025 г.

Завершение исследования (Оцененный)

26 августа 2026 г.

Даты регистрации исследования

Первый отправленный

22 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

28 мая 2026 г.

Первый опубликованный (Действительный)

1 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

1 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

28 мая 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • 106/SRC/Sep.23.2024

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

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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