Repair of Vertically Fractured Root

NCT04430205 | Completed

• 1 other identifier: 2370CELazio1
• Study Type: observational
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim and background: The aim of this retrospective observational study is to evaluate the survival rate of cracked teeth, presenting partial (PVF) or complete vertical fracture (CVF), after tooth restoration either with fracture-fragment adhesive bonding or with amalgam restoration. Materials and Methods: One hundred eight fractured teeth, from 99 patients (51 males, 48 females, mean age 50.5 years), presenting complete or partial root fracture, were treated with adhesive restoration or non-adhesive restoration protocol (amalgam) between 1991 and 2019. Demographic and clinical variables were evaluated as predictors of extraction. Furthermore, the bone loss/recovery due to therapy for the fracture was radiographically evaluated at the one year follow-up. All cases were treated by the same operator, using a surgical microscope. Statistical analysis was performed with IBM SPSS Statistics. The study was approved by the ethical committee of Sistema Sanitario Nazionale (prot. N°2370CELazio1).

Conditions

Root; Fracture

Outcome Measures

Primary Outcomes (1)

• Results

  Survival rate of teeth with vertical root fracture will be considered at one, three, five and more than five years, and a qualitative evaluation of the tooth will be given, clinically and radiographically: * success: tooth is asymptomatic and there is not radiographc lesion; * functional success: the tooth is asymptomatic but there is a radiographic lesion; * failure: the tooth would be extracted because of symptoms and/or radiographic lesion getting worse; * extracted: the tooth was extracted before the control visit.

  from 1991 to 2019

Interventions

Adhesive restoration protocol PROCEDURE

The canal walls were etched with 37% orthophosphoric acid for 30 seconds with use of a microbrush. The primer was applied on the wet canal walls, with a microbrush several times, after checking by drying the canal, that the appearance of the dentine was shiny and not opaque or chalky. The next step was the application of bonding with a microbrush, blowing in the fracture line to make sure it is not loaded with bonding. Flow composite was used to make it penetrate the fracture line with the help of a 0.06 mm k-file. The canals were filled with dual composite parts more deeply, light cured at the canal entrance and pulp chamber; the following phase was the coronal restoration with a sandwich technique, covering the cusp with composite.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

One hundred eight fractured teeth, from 99 patients (51 males, 48 females, mean age 50.5 years, standard deviation (SD) 12.8, range 23-84), presenting complete or partial root fracture

You may qualify if:

• Any patient with at least one tooth with a vertical root fracture

You may not qualify if:

• any patient who does not have at least one tooth with a vertical root fracture

Sponsors & Collaborators

• Centro di Ricerca Odonotiatrica e Corsi di Aggiornamento Professionale: lead

Related Publications (1)

• Malentacca A, Zaccheo F, Scialanca M, Fordellone F, Rupe C, Lajolo C. Repair of teeth with cracks in crowns and roots: An observational clinical study. Int Endod J. 2021 Oct;54(10):1738-1753. doi: 10.1111/iej.13598. Epub 2021 Aug 16.

  PMID: 34291470 DERIVED

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 12, 2020
• Study Start: July 15, 1991
• Primary Completion: September 5, 2019
• Study Completion: December 19, 2019
• Last Updated: June 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share