Success of Zirconia and Composite Strip Crowns for Primary Incisors

NCT05034003 | Completed

• 1 other identifier: anterior crown rest
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate and compare the clinical and radiographic performance of zirconia and composite strip crowns bonded on primary incisors

Conditions

Dental Caries in Children

Keywords

zirconia crowns, composite strip crowns, dental caries

Outcome Measures

Primary Outcomes (1)

• Number of zirconia and composite strip crowns that showed successful retention over two years

  Long-term clinical success of zirconia and composite strip crowns placed on primary incisors

  2 years

Study Arms (3)

zirconia crowns

EXPERIMENTAL

Zirconia crowns placed on primary incisor teeth

Device: Zirconia crown

composite strip crowns

EXPERIMENTAL

composite strip crowns placed on primary incisor teeth

Device: composite strip crown

Control tooth

NO INTERVENTION

Caries-free primary incisor tooth

Interventions

Zirconia crown DEVICE

Esthetic crowns for capping primary incisor with caries

zirconia crowns

composite strip crown DEVICE

Esthetic resin restoration for primary incisor with caries

composite strip crowns

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients and parent of the patients who accept to participate and sign the informed consent
• Patients who have at least two primary maxillary incisor with caries that require crown restoration
• Teeth that have healthy lamina dura and periodontal ligament
• Teeth with no mobility and enough root length
• Patients that have good cooperation to the procedure

You may not qualify if:

• Patients and parent of the patients who don't accept to participate and sign the informed consent
• Teeth that are previously restored
• Patients who are uncooperative
• Teeth that doesn't have opposing primary incisors
• Patients who have bruxism or deep-bite
• Teeth that are close to be erupted
• Teeth that have vital or non-vital pulp therapy

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• zafer c cehreli

  Hacettepe university , Faculty of dentistry, ankara/Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 5, 2021
• Study Start: August 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: January 1, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

TU (1)