Trial Outcomes & Findings for Survival of Endocrowns Made From Different Ceramics (NCT NCT03542019)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

24 months

Results posted on

2021-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	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 Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelain	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 Dental crown: Replacement og missing tooth structure using monolithic zirconia	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 Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic
Overall Study STARTED	20	20	20
Overall Study COMPLETED	19	17	19
Overall Study NOT COMPLETED	1	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lithium Disilicate n=20 Participants 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 n=20 Participants 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 n=20 Participants 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 n=60 Participants Total of all reporting groups
Age, Continuous	30.8 years STANDARD_DEVIATION 10.6 • n=20 Participants	38.1 years STANDARD_DEVIATION 14.9 • n=20 Participants	33.4 years STANDARD_DEVIATION 11.2 • n=20 Participants	34.1 years STANDARD_DEVIATION 12.6 • n=60 Participants
Sex: Female, Male Female	15 Participants n=20 Participants	13 Participants n=20 Participants	11 Participants n=20 Participants	39 Participants n=60 Participants
Sex: Female, Male Male	5 Participants n=20 Participants	7 Participants n=20 Participants	9 Participants n=20 Participants	21 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Jordan	20 participants n=20 Participants	20 participants n=20 Participants	20 participants n=20 Participants	20 participants n=60 Participants

PRIMARY outcome

Timeframe: 24 months

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

Outcome measures

Outcome measures
Measure	Lithium Disilicate n=19 Teeth 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 n=17 Teeth 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 n=19 Teeth 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
Survival of Dental Prosthesis	19 Teeth	14 Teeth	17 Teeth

Adverse Events

Lithium Disilicate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Monolithic Zirconia

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Hybrid Ceramic

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lithium Disilicate n=20 participants at risk 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 n=20 participants at risk 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 n=20 participants at risk 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
Product Issues Debonding	0.00% 0/20 • 24 months Debonding, fracture, poor appearance, or if the tooth was deemed non-restorable during the 24-month observation period.	15.0% 3/20 • Number of events 3 • 24 months Debonding, fracture, poor appearance, or if the tooth was deemed non-restorable during the 24-month observation period.	10.0% 2/20 • Number of events 2 • 24 months Debonding, fracture, poor appearance, or if the tooth was deemed non-restorable during the 24-month observation period.

Additional Information

Dr. Ahmad El-Ma'aita

University of Jordan

Phone: +9626535 5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place