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

NCT06299150 | Completed

• 1 other identifier: 2023-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Clinical success/ survival

  * Clinical success will evaluate using (a modified version of the United States Public Health Service (USPHS) criteria). \[Appendix A\] * Each parameter will assess using visual and tactile observations (probe and mirror). * At the checkup visits (3, 6, 9, 12 months), will take standardized photographs and the restorations will clinically evaluate by an independent and calibrated clinician. * The need for replacement and partial fractures (chippings) will define as failures

  12 months

Study Arms (2)

direct resin composite mini-veneer

ACTIVE COMPARATOR

Composites resins have become the first choice for direct anterior and posterior restorations. The great popularity is related to their esthetic appearance and reduced need of sound tissue removal as compared with former treatments. Several studies have demonstrated that composite restorations may last long in clinical service. Composite restorations have demonstrated a good clinical performance with annual failure rates varying from 1% to 3% in posterior teeth and 1% to 5% in anterior teeth.

Other: IPS e.max CAD

IPS e.max CAD

EXPERIMENTAL

"IPS e max" likely refers to a type of dental material or technology. IPS e.max is a popular brand of lithium disilicate glass-ceramic used in dentistry for the fabrication of dental restorations such as crowns, veneers, inlays, onlays, and bridges. IPS e.max restorations are known for their excellent esthetics, strength, and durability. They are designed to closely mimic the natural appearance of teeth while providing reliable performance and longevity. Dentists often choose IPS e.max restorations for their patients due to their versatility and ability to meet both esthetic and functional requirements.

Other: IPS e.max CAD

Interventions

IPS e.max CAD OTHER

CAD CAM Restoration

IPS e.max CAD; direct resin composite mini-veneer

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• Ellis Class II traumatized central incisors
• Controlled dental disease - no active caries or periodontal diseases
• Patients will be available to be clinically reviewed up to 1 year

You may not qualify if:

• All Ellis Classification traumatized central incisors except Ellis Class II
• Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing).
• Poor oral hygiene and motivation.
• Patients with parafunctional habits (e.g., bruxism, biting on hard objects).
• Patients with debilitating illnesses or complicating medical conditions

Sponsors & Collaborators

• October University for Modern Sciences and Arts: lead

Study Sites (1)

MSA University

El-Sheikh Zayed City, Giza Governorate, 16672, Egypt

Location

MeSH Terms

Interventions

IPS e.max CAD LT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study is a randomized clinical trial (RCT) where 2 arm parallel groups with a 1:1 allocation ratio were compared. The child participants and the legal guardian of each participating child and the statistician were blinded.

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 7, 2024
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)