Survival of Endocrowns Made From Different Ceramics

• Sponsor: University of Jordan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03542019
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Actual Duration (Months): 30
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

Restoration of endodontically treated teeth requires a means to protect the cusps from the wedging forces of occlusion. When there is extensive loss of tooth structure, cuspal coverage is warranted. Usually this is in the form of indirect restoration. Traditionally, full coverage crowns have been used which would require further removal of sound tooth structure. Recently, adhesive alternatives have been introduced which allow for conservation of tooth structure.

Different materials can be used for this purpose. The evidence on the long-term survival of these materials is scarce. This study aims to investigate the short and medium-long term survival rate of these prostheses.

Condition or Disease	Intervention/Treatment	Phase
Pulp Disease, Dental; Dental Caries; Dental Leakage	Device: Dental prosthesis; Device: Dental crown; Device: Hybrid ceramic	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Three different ceramic types for restoration of endodontically treated teethThree different ceramic types for restoration of endodontically treated teeth
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: All ceramic materials will be assigned randomly by research assistant who has randomised tables generated by a statistician
• Primary Purpose: Treatment
• Official Title: The Endocrown; a Prospective Randomised Clinical Trial of Three Different Ceramics
• Actual Study Start Date: Jul 1, 2018
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lithium disilicate Lithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns	Device: Dental prosthesis; Replacement of missing tooth structure using Lithium disilicate porcelain; Other Names: Crowns
Active Comparator: Monolithic zirconia Monolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns	Device: Dental crown; Replacement og missing tooth structure using monolithic zirconia; Other Names: Endocrown
Active Comparator: Hybrid ceramic Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns	Device: Hybrid ceramic; Restroration of endodontically treated teeth using hybrid ceramic; Other Names: Indirect restoration

Outcome Measures

Primary Outcome Measures

1. Survival of Dental Prosthesis [24 months]

   The endocrowns (the dental prosthesis studied) were assessed after 24 months. Those that were functional and without any symptoms were considered surviving.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Root canal treated molars with significant loss of tooth structure

• Supra-gingival margins

• Teeth scheduled for cuspal-covering indirect restorations

Exclusion Criteria:

• Teeth with extensive cracks or fractures

• Teeth with deep subgingival margins

• Non-functional teeth (no opposing dentition)

• Teeth with advanced periodontitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jordan University Hospital	Amman		Jordan	11831

Sponsors and Collaborators

• University of Jordan

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 10, 2018

More Information

Publications

None provided.

• Responsible Party: Ahmad El-Ma'aita, Assistant Professor - Consultant endodontist, University of Jordan
• ClinicalTrials.gov Identifier: NCT03542019
• Other Study ID Numbers: 10/2017/25289
• First Posted: May 31, 2018
• Last Update Posted: Nov 4, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dental Caries; Dental Pulp Diseases; Stomatognathic Diseases; Dental Leakage

Study Results

Participant Flow

Arm/Group Title	Lithium Disilicate	Monolithic Zirconia	Hybrid Ceramic
Arm/Group Description	Lithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelain	Monolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns Dental crown: Replacement og missing tooth structure using monolithic zirconia	Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic
Period Title: Overall Study
STARTED	20	20	20
COMPLETED	19	17	19
NOT COMPLETED	1	3	1

Baseline Characteristics

Arm/Group Title	Lithium Disilicate	Monolithic Zirconia	Hybrid Ceramic	Total
Arm/Group Description	Lithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelain	Monolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns Dental crown: Replacement og missing tooth structure using monolithic zirconia	Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic	Total of all reporting groups
Overall Participants	20	20	20	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.8 (10.6)	38.1 (14.9)	33.4 (11.2)	34.1 (12.6)
Sex: Female, Male (Count of Participants)
Female	15 75%	13 65%	11 55%	39 65%
Male	5 25%	7 35%	9 45%	21 35%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Jordan	20 100%	20 100%	20 100%	20 33.3%

Outcome Measures

1. Primary Outcome

Title	Survival of Dental Prosthesis
Description	The endocrowns (the dental prosthesis studied) were assessed after 24 months. Those that were functional and without any symptoms were considered surviving.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lithium Disilicate	Monolithic Zirconia	Hybrid Ceramic
Arm/Group Description	Lithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelain	Monolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns Dental crown: Replacement og missing tooth structure using monolithic zirconia	Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic
Measure Participants	16	17	18
Measure Teeth	19	17	19
Count of Units [Teeth]	19	14	17

Adverse Events

Time Frame	24 months
Adverse Event Reporting Description	Debonding, fracture, poor appearance, or if the tooth was deemed non-restorable during the 24-month observation period.
Arm/Group Title	Lithium Disilicate		Monolithic Zirconia		Hybrid Ceramic
Arm/Group Description	Lithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelain		Monolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns Dental crown: Replacement og missing tooth structure using monolithic zirconia		Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic
All Cause Mortality
	Lithium Disilicate		Monolithic Zirconia		Hybrid Ceramic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Lithium Disilicate		Monolithic Zirconia		Hybrid Ceramic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Lithium Disilicate		Monolithic Zirconia		Hybrid Ceramic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		3/20 (15%)		2/20 (10%)
Product Issues
Debonding	0/20 (0%)	0	3/20 (15%)	3	2/20 (10%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.