Evaluation and Treatment of Crown Fractures Using the Modified Baysal Dental Trauma Index

NCT07131462 | Active Not Recruiting

• 1 other identifier: 2023/69
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted by the Department of Pediatric Dentistry, Faculty of Dentistry, İnönü University, with the aim of evaluating the treatment processes and follow-up responses of patients aged between 6 and 14 years who will present with crown fractures in their maxillary or mandibular permanent incisors. Written informed consent will be obtained from the parents of all participating patients. The research will be carried out using a prospective observational design. Initially, sociodemographic information as well as personal data such as the child's age and gender will be collected through a questionnaire designed for the parents. Additionally, trauma-related information-including the time, location, and cause of the injury-will be recorded in detail using a trauma assessment form developed for the study. Each patient will undergo clinical and radiographic evaluations, and treatment planning and follow-up will be carried out based on these findings.

Conditions

Dental Trauma; Crown Fractures; Tooth Fractures

Keywords

Complicated Crown Fractures; Uncomplicated Crown Fractures; Modified Baysal Dental Trauma Index; Permanent Teeth; Pediatric Dentistry

Outcome Measures

Primary Outcomes (1)

• Proportion of Treated Teeth Without Clinical Symptoms or Radiographic Pathology at 12 Months (PAI Score ≤ 2)

  Treatment success will be defined as the absence of spontaneous pain, swelling, sinus tract, abnormal mobility, discoloration, and the presence of radiographic healing or absence of periapical pathology, as assessed using the Periapical Index (PAI) by Ørstavik et al. (1986). Evaluations will be performed at 12 months post-treatment.

  12 months

Secondary Outcomes (1)

• Change in Periapical Index (PAI) Score From Baseline to 12 Months

  12 months

Study Arms (1)

Dental Trauma - Crown Fracture Group

EXPERIMENTAL

This arm includes children aged 6 to 14 years who present with crown fractures due to dental trauma. Treatment modality (direct composite restoration, Cvek pulpotomy, or endodontic therapy) will be selected based on clinical and radiographic findings. All patients will be followed over time to assess treatment outcomes.

Procedure: Direct Composite Restoration; Procedure: Cvek Pulpotomy; Procedure: Endodontic Treatment; Procedure: Pulp Capping

Interventions

Direct Composite Restoration PROCEDURE

Application of direct composite resin to restore the fractured crown of permanent incisors.

Dental Trauma - Crown Fracture Group

Cvek Pulpotomy PROCEDURE

Partial pulpotomy (Cvek technique) will be performed for complicated crown fractures with vital pulp exposure. The goal is to maintain pulp vitality using biodentin.

Dental Trauma - Crown Fracture Group

Endodontic Treatment PROCEDURE

Root canal treatment will be applied to teeth with necrotic pulp or extensive pulp exposure not suitable for vital pulp therapy. Procedures will follow standard endodontic protocols.

Dental Trauma - Crown Fracture Group

Pulp Capping PROCEDURE

In cases of minimal pulp exposure, a direct pulp capping procedure will be performed using biocompatible materials such as calcium hydroxide to preserve pulp vitality.

Dental Trauma - Crown Fracture Group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 6 and 14 years
• Presence of traumatic dental injury involving a permanent tooth
• Type of injury classified as a complicated or uncomplicated crown fracture
• Informed consent obtained from the patient's parent or legal guardian

You may not qualify if:

• Patients younger than 6 or older than 14 years, or those presenting for non-trauma-related dental issues
• Patients with traumatic dental injuries other than crown fractures (e.g., luxation, avulsion)

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University Faculty of Dentistry

Malatya, 44100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth Fractures

Interventions

Endodontics; Dental Pulp Capping

Condition Hierarchy (Ancestors)

Tooth Injuries; Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Tuba Aydan, Pediatric Dentistry Specialist

  Inonu University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Dentistry Specialist, Principal Investigator

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 20, 2025
• Study Start: January 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)