An In Vitro Evaluation of Fracture Resistance of Endodontically Treated Teeth Restored With New Contemporary Core Build-up Materials

NCT05079646 | Completed

• 1 other identifier: MDaud
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Endodontic treatment is performed frequently which often results in weakening of tooth structure. Coronal restoration is done to restore these endodontically treated teeth. Posts have been used to retain the coronal restoration and reinforce these teeth but unfortunately posts placement results in further weakening of tooth structure. Newer contemporary core buildup materials will be used to restore coronal part of tooth without using endodontic posts and then the fracture resistance of these teeth will be evaluated. This study will be performed to evaluate the fracture resistance of endodontically treated teeth restored with newer contemporary core buildup materials. 80 recently extracted single rooted caries-free and unrestored premolars will be taken and mounted in acrylic resin blocks. Roots of teeth will be covered with light bodies of condensation silicone impression material to simulate periodontal ligaments. Class 1 and class 2 cavities will be prepared and endodontic treatment will be performed in these teeth specimens. Coronal restoration will be done with three core buildup materials (Cention-N, Zirconomer and Aristaloy Amalgam). Teeth specimens are then divided into group 1 and group 2 (class 1 cavity preparation and class 2 cavity preparation respectively) and each group is further divided into four subgroups: Subgroup A: Control group Subgroup B: Cavities restored with Zirconomer (Shofu) Subgroup C: Cavities restored with Cention-N (Ivoclar vivodent) Subgroup D: Cavities restored with Aristaloy Amalgam (Cookson) Fracture resistance of endodontically treated teeth restored with different core buildup materials will be tested by the Universal testing machine.

Conditions

Fracture Resistance

Outcome Measures

Primary Outcomes (1)

• fracture resistance (newton) will be measured under universal testing machine

  fracture resistance of endodontically treated teeth which were restored with contemporary core buildup materials.

  Immediately after intervention

Study Arms (8)

Group 1, subgroup A (blue color coded)

NO INTERVENTION

Normal teeth with no cavity preparation and no endodontic procedure.

Group 1, subgroup B (pink color coded)

EXPERIMENTAL

Teeth specimens in which endodontic procedure will be performed and coronal restoration will be done with Zirconomer (shofu).

Other: class 1 and class 2 cavity preparation and restored with contemporary materials

Group 1, subgroup C (green color coded)

EXPERIMENTAL

Teeth specimens in which endodontic procedure will be performed and coronal restoration will be done with Cention-N (Ivoclar vivodent)

Other: class 1 and class 2 cavity preparation and restored with contemporary materials

Group 1, subgroup D (black color coded) positive control group

ACTIVE COMPARATOR

Teeth specimens in which endodontic procedure will be performed and coronal restoration will be done with Aristaloy Amalgam (Cookson)

Other: class 1 and class 2 cavity preparation and restored with contemporary materials

Group 2, Subgroup A (Blue color coded) negative control group

NO INTERVENTION

Normal teeth with no cavity preparation and no endodontic procedure.

Group 2, Subgroup B (pink color coded)

EXPERIMENTAL

Teeth specimens in which endodontic procedure will be performed and coronal restoration will be done with Zirconomer (shofu) by using tofflemire retainer and matrix band.

Other: class 1 and class 2 cavity preparation and restored with contemporary materials

Group 2, Subgroup C (green color coded)

EXPERIMENTAL

Teeth specimens in which endodontic procedure will be performed and coronal restoration will be done with Cention-N (Ivoclar vivodent) by using tofflemire retainer and matrix band.

Other: class 1 and class 2 cavity preparation and restored with contemporary materials

Group 2, Subgroup D (black color coded)

ACTIVE COMPARATOR

Teeth specimens in which endodontic procedure will be performed and coronal restoration will be done with Aristaloy Amalgam (Cookson) by using tofflemire retainer and matrix band.

Other: class 1 and class 2 cavity preparation and restored with contemporary materials

Interventions

class 1 and class 2 cavity preparation and restored with contemporary materials OTHER

class 1 and class 2 cavities prepared in extracted teeth after endodontic procedure and then these cavities were filled with new contemporary core buildup materials.

Group 1, subgroup B (pink color coded); Group 1, subgroup C (green color coded); Group 1, subgroup D (black color coded) positive control group; Group 2, Subgroup B (pink color coded); Group 2, Subgroup C (green color coded); Group 2, Subgroup D (black color coded)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Teeth extracted from the age group of 18-30 years
• Single rooted lower 2 nd premolars
• Sound teeth with no caries

You may not qualify if:

• Incompletely closed apices
• Root resorption, fracture, or craze lines
• Endodontically treated or restored teeth

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

DIKIOHS

Karachi, Sindh, 75300, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 15, 2021
• Study Start: November 16, 2020
• Primary Completion: February 20, 2021
• Study Completion: February 25, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

PA (1)