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Prefabricated CAD/CAM PEEK Crowns For Primary Molars Restoration

28 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Damascus, Siria
        • School of Dental Medicine

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Experimental: 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.
Experimental: 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.
Comparador activo: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gingival Index
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Color Stability
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Colaboradores

Investigadores

  • Investigador principal: Bushra Munzer Shamma, MSc, DDS., Damascus University
  • Silla de estudio: Mohannad Laflouf, PhD, MSc, DDS., Damascus University
  • Director de estudio: Saleh Al Kurdi, PhD, MSc, DDS., Arab International University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

2 de abril de 2024

Finalización primaria (Actual)

10 de diciembre de 2025

Finalización del estudio (Estimado)

26 de agosto de 2026

Fechas de registro del estudio

Enviado por primera vez

22 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de mayo de 2026

Publicado por primera vez (Actual)

1 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 106/SRC/Sep.23.2024

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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