Prefabricated CAD/CAM PEEK Crowns For Primary Molars Restoration

Summary

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.

Conditions

• Dental Esthetic, Dental Care for Children, Dental Crowns

Interventions

PROCEDURE

Prefabricated CAD/CAM PEEK with 0.2 mm 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.

PROCEDURE

Prefabricated CAD/CAM PEEK with 0.4 mm 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.

PROCEDURE

CAD/CAM-fabricated PEEK Crowns

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.

PROCEDURE

Satinless steel crowns

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

Sponsors & Collaborators

• Damascus University

  collaborator OTHER

• Arab International University

  lead OTHER

Principal Investigators

• Bushra Munzer Shamma, MSc, DDS. · Damascus University

• Mohannad Laflouf, PhD, MSc, DDS. · Damascus University

• Saleh Al Kurdi, PhD, MSc, DDS. · Arab International University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

5 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-02

Primary Completion

2025-12-10

Completion

2026-08-26

Countries

• Syria

Study Locations