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Clinical Evaluation of Three Different Techniques Restoring Ellis Class II Traumatized Central Incisors In Children

NCT06299150 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-20

No results posted yet for this study

Summary

Dental trauma (DT) of the incisors and their supporting tissues, one of the most challenging dental emergencies, requires immediate assessment and management due to psychological and physical reasons. This is especially important for young permanent teeth to minimize undesired complications. The treatment of dental trauma is sometimes neglected, although it might lead to pain, difficulty in articulation and mastication, and considerable negative effects on a patient's self-esteem. However, the aesthetics of the anterior teeth are very important aspects of human appearance and can be affected by many factors, including the presence of fillings, tooth color, position, alignment, shape, and number.

Rasmussen ST et al. discovered in 1981 that most children suffer from tooth trauma. According to their research, 25% of all schoolchildren and 33% of adults have undergone trauma, with the majority of cases occurring before the age of 19.

As the maxillary incisors are the most commonly injured teeth due to their exposed position, a functional, aesthetic, and time-efficient restoration is frequently demanded. According to the current International Association of Dental Traumatology guidelines, crown fractures confined to enamel and dentine may be treated either with a direct composite restoration or with an adhesive reattachment of the fractured fragment. As long as the fragment is intact, reattachment is often preferred in dental practice. This technique facilitates the restoration of the tooth with its original anatomy, color, and function in a minimum amount of time. Unfortunately, clinical studies regarding the survival of reattached fragments are scarce, and results from laboratory investigations cannot be transferred to clinical settings without limitations. Furthermore, longevity data of direct composite restorations in fractured anterior teeth are restricted to a few clinical studies.

In addition to the aforementioned restorative alternatives, the use of small partial glassy restorations-partial laminate veneers (PLVs), sectional veneers, or ceramic fragments has become increasingly popular over the last few years. PLVs are thin pieces of glass matrix ceramic fragments without a defined shape that are used to restore small defects in the anterior teeth. As tooth preparation is not required for this type of restoration, and minimal to no prep is accepted, the maximum amount of enamel surface structure is conserved. Thus, retention relies completely on adhesion, which is primarily achieved by bonding to the conditioned glassy surface. Despite their growing popularity, available data in the literature on PLVs are limited to a few in vitro studies and case reports, without any clinical information available at present.

Patients in all groups will receive a minimally invasive restoration with high esthetic advantages and long-term success of their fractured incisors (either conventional composite restoration, fragment reattachment, or partial laminate veneers) that require minimal to no preparation and do not require local anesthesia.

Conditions

  • Composites Resins

Interventions

OTHER

IPS e.max CAD

CAD CAM Restoration

Sponsors & Collaborators

  • October University for Modern Sciences and Arts

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06299150 on ClinicalTrials.gov