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Fracture ResistanceNCT05079646

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

A study testing class 1 and class 2 cavity preparation and restored with contemporary materials in people with Fracture Resistance, run by Dow University of Health Sciences at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Fracture Resistance
What is being tested?
class 1 and class 2 cavity preparation and restored with contemporary materials
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 sitePakistan
Study dates
16 Nov 2020to 25 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • DIKIOHS

    Karachi, Sindh, 75300

Other trials in Pakistan

About this study

Official title: An In Vitro Evaluation of Fracture Resistance of Endodontically Treated Teeth Restored With New Contemporary Core Build-up Materials: A Randomized Control Trial

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.

Read the detailed description

Total 80 recently extracted single rooted lower second premolars, extracted for orthodontic treatment, will be selected for this study. Because lower second premolars are commonly extracted for orthodontic purposes and during mastication, the anatomic shape ofpremolars create tendency for separation of cusps. Indenter contacts the tooth and acts as a wedge between buccal and lingual cusps and decrease mean fracture resistance values. So the application of force vertically on cusp inclines found to be appropriate to simulate intraoral clinical conditions.

Teeth will be washed under running water and any soft tissue attached to root surfaces will be scraped off with hand scaler. Teeth disinfected with 0.1% thymol solution and will be stored in 10% formalin solution for four days atleast, until they are used, teeth will be stored in 0.9% saline solution at room temperature.

With the help of computer generated software, Teeth will be randomly divided into two groups. Each group contains 40 teeth. Class 1 cavity preparation will be done in teeth of group 1 with straight fissure diamond bur (HiCare ISO. 109/010) in high speed handpiece (Nsk, Japan) along with water coolant and cavity will be prepared on occlusal fissures.

Intercuspal distance and mesio-distal dimension of teeth will be measured with digital caliper. The buccolingual width of class 1 cavity will be one-third of the distance between buccal and lingual cusps and mesiodistal width would be one-third of mesio-distal distance. Buccal and lingual walls will be parallel to one other and cavo-surface angle of approximately 90 degree will be prepared. Class 2 cavity will be prepared in teeth of group 2, in the same way as class 1 except that proximal box will also be prepared in class 2. The width of occlusal isthmus will be the one-third of intercuspal distance and the buccolingual dimension of approximal preparation will be the one-third of buccolingual dimension of overall crown. Gingival extent of this approximal preparation will be 1mm coronal to cemento-enamel junction and the gingival width would be of 2 +/- 0.2mm. Buccal and lingual walls of occlusal preparation will be parallel to each other.

Class 1 and class 2 cavities are prepared because occlusal and proximal surfaces of teeth are the main surfaces which are subjected to higher forces during mastication and these two surfaces are more susceptible to caries attack and standard method for access opening is from occlusal and proximal surface (if carious lesion involve proximal surface too).

Access cavity for endodontics will be prepared with diamond round bur (HiCare ISO.

001/010). The working length will be taken by introducing the #10 K-file (Mani) in the canal until it becomes visible from apical foramen, The working length will be determined by subtracting 1mm from this estimated length. Endodontic procedure will be carried out in all teeth specimens by using rotary Protaper files (Densply). Sequence of S1, S2 and then F1 and F2 will be followed to prepare the canals at the working length. Canals will be irrigated thoroughly after every file with 2.5% NaOCl solution. After cleaning and shaping, canals will be dried with paper points and obturation will be done with sealer (Sealapex, SybronEndo-Kerr, Glendora, CA, USA) and F2 gutta percha cone (Densply).

Modeling wax will be melted and root of tooth will be dipped in it below cement-enamel junction, this will produce a layer of 0.2 to 0.3 mm of wax on root surfaces. This thickness of wax on root surfaces will be representative to the thickness of periodontal ligament. Teeth will be placed in acrylic resin block of 3cmx 2.5cm such that 1.0 mm of root below cement-enamel junction will be out of the block to simulate the biologic width. Wax will be used as spacer between root and acrylic resin block and will be removed. Light body of condensation silicone impression material will be mixed and poured into resin block. Teeth will be reinserted into acrylic resin blocks with the silicone impression material, which will simulate periodontal ligament. Since the PDL acts as an effective support during the masticatory function and absorb and transmit forces between teeth and alveolar bone. So, to produce the clinical situation and to provide a more accurate assessment of fracture resistance of teeth, teeth are embedded in light body of condensation silicone impression material.

Now, Each group will be randomly divided into four sub-groups. In each sub-group, there will be 10 teeth specimens. To make identification of specimens, each group and sub-group will be color coded. There will be one positive control group and one negative control group among the four subgroups and rest 2 sub-groups will be restored with new contemporary core buildup materials.

GROUP 1 (Yellow color coded) Class 1 cavity preparation

Sub-groups

A (Blue color coded) negative control group: Normal teeth with no cavity preparation and no endodontic procedure.

B (Pink color coded): teeth specimens in which endodontic procedure was performed and coronal restoration was done with Zirconomer (Shofu) C (Green color coded) : teeth specimens in which endodontic procedure was performed and coronal restoration was done with Cention-N (Ivovclar vivodent) D (Black color coded) : teeth specimens in which endodontic procedure was performed and coronal restoration was done with Aristaloy Amalgam (cookson)

GROUP 2 (Purple color coded) Class 2 cavity preparation

Sub-groups

A (Blue color coded) negative control group: Normal teeth with no cavity preparation and no endodontic procedure B (Pink color coded): teeth specimens in which endodontic procedure was performed and coronal restoration was done with Zirconomer (Shofu) by using tofflemire retainer and matrix band.

C (Green color coded) : teeth specimens in which endodontic procedure was performed and coronal restoration was done with Cention-N (Ivovclar vivodent) by using tofflemire retainer and matrix band.

D (Black color coded) : teeth specimens in which endodontic procedure was performed and coronal restoration was done with Aristaloy Amalgam (cookson) by using tofflemire retainer and matrix band.

Each tooth specimen will be individually tested in the Universal testing machine (UTM, INSTRON - 4301 Sr. # H1853, PCSIR Karachi). Tooth specimen will be placed in the holding slot that will be attached to the lower part of testing machine. Rounded stainless steel probe of diameter 6mm will be attached to the upper part of machine. Since, We are evaluating the fracture resistance of tooth that whether the new contemporary material enhances the fracture resisting ability of tooth, the probe will contact the inclined planes of facial and lingual cusps of tooth beyond the margins of restoration. The force will start from 'zero' Newton and then indenter will apply the increasing compressive loads to the inclined planes of buccal and lingual cusps until the tooth fractures and final force (Newtons) will be noted. The applied load would be parallel to the long axis of teeth. Load will be applied at crosshead speed of 1mm/min and will be increased gradually until fracture occurs. Maximum force required to fracture the tooth will be recorded in Newtons.

All sample preparation will be done by the principle investigator and sample testing and scoring will be done by a blinded examiner.

Being tested
class 1 and class 2 cavity preparation and restored with contemporary materials

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • class 1 and class 2 cavity preparation and restored with contemporary materialsOther

    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.

Study groups in NCT05079646
Study groupRoleWhat they receive
Group 1, subgroup A (blue color coded)No interventionNormal teeth with no cavity preparation and no endodontic procedure.
Group 1, subgroup B (pink color coded)ExperimentalTeeth specimens in which endodontic procedure will be performed and coronal restoration will be done with Zirconomer (shofu).
Receives: Other: class 1 and class 2 cavity preparation and restored with contemporary materials
Group 1, subgroup C (green color coded)ExperimentalTeeth specimens in which endodontic procedure will be performed and coronal restoration will be done with Cention-N (Ivoclar vivodent)
Receives: Other: class 1 and class 2 cavity preparation and restored with contemporary materials
Group 1, subgroup D (black color coded) positive control groupActive comparatorTeeth specimens in which endodontic procedure will be performed and coronal restoration will be done with Aristaloy Amalgam (Cookson)
Receives: Other: class 1 and class 2 cavity preparation and restored with contemporary materials
Group 2, Subgroup A (Blue color coded) negative control groupNo interventionNormal teeth with no cavity preparation and no endodontic procedure.
Group 2, Subgroup B (pink color coded)ExperimentalTeeth specimens in which endodontic procedure will be performed and coronal restoration will be done with Zirconomer (shofu) by using tofflemire retainer and matrix band.
Receives: Other: class 1 and class 2 cavity preparation and restored with contemporary materials
Group 2, Subgroup C (green color coded)ExperimentalTeeth 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.
Receives: Other: class 1 and class 2 cavity preparation and restored with contemporary materials
Group 2, Subgroup D (black color coded)Active comparatorTeeth 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.
Receives: Other: class 1 and class 2 cavity preparation and restored with contemporary materials

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Immediately after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2021
  2. Study start16 Nov 2020
  3. Primary completion20 Feb 2021
  4. Study completion25 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05079646
Sponsor's protocol ID
MDaud
Status last verified
Oct 2021
First submitted
22 Sep 2021
Last updated
15 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing class 1 and class 2 cavity preparation and restored with contemporary materials in people with Fracture Resistance, run by Dow University of Health Sciences at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fracture resistance (newton) will be measured under universal testing machine (time frame: Immediately after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.

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