## Protocol Section
### Identification Module
**NCT ID:** NCT03036579

**Brief Title:** Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study

**Official Title:** Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Zirconia-reinforced Lithium Silicate Ceramic Crowns

#### Organization Study ID Info
**ID:** HUM00103921
#### Organization
**Class:** OTHER
**Full Name:** University of Michigan
### Status Module
#### Completion Date
**Date:** 2019-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-04-13

**Type:** ACTUAL

**Last Update Submit Date:** 2023-03-23

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2019-09

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-04-13

**Type:** ACTUAL

**Results First Submit Date:** 2023-01-23

**Results First Submit QC Date:** 2023-03-23

#### Start Date
**Date:** 2015-11

**Status Verified Date:** 2023-03

#### Study First Post Date
**Date:** 2017-01-30
**Type:** ESTIMATED
**Study First Submit Date:** 2017-01-26
**Study First Submit QC Date:** 2017-01-26
**Why Stopped:** COVID, loss of funding
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Dentsply Sirona Inc.

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Michigan

#### Responsible Party

**Investigator Affiliation:** University of Michigan

**Investigator Full Name:** Dennis J. Fasbinder, DDS

**Investigator Title:** Clinical Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.

**Detailed Description:** The study will be composed of two groups of 50 crowns placed in adult patients that have been identified as requiring at least one crown on a posterior tooth. A maximum of two crowns per patient will be completed. All the crowns will be made from the same high strength ceramic material (Celtra Duo/Dentsply Sirona). The two groups of crowns will be made using two different processes to create the surface texture and finish for the crown. One group of Celtra Duo crowns (Group 1) will be glaze-fired in a porcelain oven and the second group (Group 2) will be hand-polished. All the crowns will be cemented using two adhesive techniques. All of the oven-fired, glazed crowns will be cemented using the self-etching, self-adhesive resin cement technique (Calibra Universal Cement/Dentsply). All of the hand polished crowns will be cemented using an adhesive bonding technique using Prime \& Bond Elect (Dentsply) with a dual cured resin cement (Calibra Ceram/Dentsply). The crowns are planned to be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. At each appointment an examination of the crown will be completed as well as clinical photographs, an intraoral digital scan, and impression of the crown.

### Conditions Module

**Conditions:**

- Fractured Tooth

- Decayed Tooth

- Unsatisfactory Restoration of Tooth

**Keywords:**

- CAD/CAM

- Ceramic

- Crown

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Final surface fabrication was not identified in the treatment process until the crown was milled.

**Who Masked:**

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 73

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement

**Intervention Names:**

- Device: Celtra Duo

**Label:** Glazed Fired, Calibra Céram

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement

**Intervention Names:**

- Device: Celtra Duo

**Label:** Hand Polished, Calibra Universal

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Glazed Fired, Calibra Céram

- Hand Polished, Calibra Universal

**Description:** Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.

**Name:** Celtra Duo

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years.

**Measure:** Crown Failure

**Time Frame:** from delivery of the crown up to 3 years

#### Secondary Outcomes

**Description:** Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.

**Measure:** Crown Loss of Retention

**Time Frame:** 3 years

**Description:** Tooth Sensitivity is evaluated as either "0" if the subject reports that there is NO sensitivity for the tooth with the study crown, or "1" if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure. The better outcome is to have NO tooth sensitivity. The number of teeth with tooth sensitivity are listed below.

**Measure:** Tooth Sensitivity

**Time Frame:** 3 years

**Description:** Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth, or "1" if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below.

**Measure:** Margin Staining

**Time Frame:** from delivery of the crown up to 3 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
* reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
* Teeth to be vital and asymptomatic prior to treatment
* No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.

Exclusion Criteria:

* Devital or sensitive teeth
* Teeth with prior endodontic treatment of any kind
* Teeth with a history of direct or indirect pulp capping procedures
* Patients with significant untreated dental disease to include periodontitis and rampant caries
* Pregnant or lactating women
* Patients with a history of allergies to any of the materials to be used in the study
* Patients unable to return for the recall appointments

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ann Arbor

**Country:** United States

**Facility:** University of Michigan

**State:** Michigan

**Zip:** 48109

#### Overall Officials

**Official 1:**

**Affiliation:** University of Michigan

**Name:** Dennis J Fasbinder, DDS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2022-05-19

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 341562

- Type Abbrev: Prot_SAP

- Upload Date: 2023-01-19T13:28

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000017001

- Term: Tooth Demineralization

- ID: D000014076

- Term: Tooth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000018677

- Term: Tooth Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M6928

- Name: Dental Caries

- Relevance: HIGH

- As Found: Decayed Teeth

- ID: M26370

- Name: Fractures, Bone

- Relevance: LOW

- As Found: Unknown

- ID: M16837

- Name: Tooth Fractures

- Relevance: HIGH

- As Found: Fractured Tooth

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M19339

- Name: Tooth Demineralization

- Relevance: LOW

- As Found: Unknown

- ID: M16831

- Name: Tooth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20757

- Name: Tooth Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003731

- Term: Dental Caries

- ID: D000014082

- Term: Tooth Fractures

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19022

- Name: Lithium Carbonate

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Glazed Fired, Calibra Céram

**Deaths Num At Risk:** 41

**Description:** Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement

Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.

**ID:** EG000

**Other Num at Risk:** 41

**Serious Number At Risk:** 41

**Title:** Glazed Fired, Calibra Céram

**Group ID:** EG001

**Title:** Hand Polished, Calibra Universal

**Deaths Num At Risk:** 32

**Description:** Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement

Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.

**ID:** EG001

**Other Num at Risk:** 32

**Serious Number At Risk:** 32

**Title:** Hand Polished, Calibra Universal

**Frequency Threshold:** 0

**Time Frame:** from baseline to 3 years

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 41

**Group ID:** BG001

**Value:** 32

**Group ID:** BG002

**Value:** 73

**Units:** Participants

**Group ID:** BG000

**Value:** 50

**Group ID:** BG001

**Value:** 50

**Group ID:** BG002

**Value:** 100

**Units:** number of teeth restored with crowns

### Group

**ID:** BG000

**Title:** Glazed Fired, Calibra Céram

**Description:** Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement

Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.

### Group

**ID:** BG001

**Title:** Hand Polished, Calibra Universal

**Description:** Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement

Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 26

#### Measurement

**Group ID:** BG001

**Value:** 23

#### Measurement

**Group ID:** BG002

**Value:** 49

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 24

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG002

**Value:** 0

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Description:** Age data not collected from any participant
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Age data not collected from any participant
**Title:** Age, Customized
**Unit of Measure:** Participants
#### Denomination 1
##### Denomination Count 1
**Group ID:** BG000
**Value:** 0
##### Denomination Count 2
**Group ID:** BG001
**Value:** 0
##### Denomination Count 3
**Group ID:** BG002
**Value:** 0
**Units:** Participants
#### Denomination 2
##### Denomination Count 1
**Group ID:** BG000
**Value:** 50
##### Denomination Count 2
**Group ID:** BG001
**Value:** 50
##### Denomination Count 3
**Group ID:** BG002
**Value:** 100
**Units:** number of teeth restored with crowns
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
#### Denomination 1
##### Denomination Count 1
**Group ID:** BG000
**Value:** 41
##### Denomination Count 2
**Group ID:** BG001
**Value:** 32
##### Denomination Count 3
**Group ID:** BG002
**Value:** 73
**Units:** Participants
#### Denomination 2
##### Denomination Count 1
**Group ID:** BG000
**Value:** 50
##### Denomination Count 2
**Group ID:** BG001
**Value:** 50
##### Denomination Count 3
**Group ID:** BG002
**Value:** 100
**Units:** number of teeth restored with crowns
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Race and Ethnicity were not collected from any participant.
**Title:** Race and Ethnicity Not Collected
**Unit of Measure:** Participants
#### Denomination 1
##### Denomination Count 1
**Group ID:** BG000
**Value:** 0
##### Denomination Count 2
**Group ID:** BG001
**Value:** 0
##### Denomination Count 3
**Group ID:** BG002
**Value:** 0
**Units:** Participants
#### Denomination 2
##### Denomination Count 1
**Group ID:** BG000
**Value:** 50
##### Denomination Count 2
**Group ID:** BG001
**Value:** 50
##### Denomination Count 3
**Group ID:** BG002
**Value:** 100
**Units:** number of teeth restored with crowns
**Population Description:** Number of teeth restored with crowns
**Type Units Analyzed:** number of teeth restored with crowns
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** djfas@umich.edu
**Organization:** University of Michigan
**Phone:** 7346474450
**Title:** Dennis J. Fasbinder, DDS
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years.
**Parameter Type:** NUMBER
**Population Description:** teeth restored with crowns
**Reporting Status:** POSTED
**Time Frame:** from delivery of the crown up to 3 years
**Title:** Crown Failure
**Type:** PRIMARY
**Type Units Analyzed:** Teeth
**Unit of Measure:** crowns
##### Group
**Description:** Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement

Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
**ID:** OG000
**Title:** Glazed Fired, Calibra Céram
##### Group
**Description:** Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement

Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
**ID:** OG001
**Title:** Hand Polished, Calibra Universal
#### Outcome Measure 2
**Description:** Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.
**Parameter Type:** NUMBER
**Population Description:** number of crowns
**Reporting Status:** POSTED
**Time Frame:** 3 years
**Title:** Crown Loss of Retention
**Type:** SECONDARY
**Type Units Analyzed:** Teeth
**Unit of Measure:** crowns
##### Group
**Description:** Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement

Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
**ID:** OG000
**Title:** Glazed Fired, Calibra Céram
##### Group
**Description:** Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement

Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
**ID:** OG001
**Title:** Hand Polished, Calibra Universal
#### Outcome Measure 3
**Description:** Tooth Sensitivity is evaluated as either "0" if the subject reports that there is NO sensitivity for the tooth with the study crown, or "1" if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure. The better outcome is to have NO tooth sensitivity. The number of teeth with tooth sensitivity are listed below.
**Parameter Type:** NUMBER
**Population Description:** number of teeth with crown
**Reporting Status:** POSTED
**Time Frame:** 3 years
**Title:** Tooth Sensitivity
**Type:** SECONDARY
**Type Units Analyzed:** Teeth
**Unit of Measure:** Teeth
##### Group
**Description:** Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement

Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
**ID:** OG000
**Title:** Glazed Fired, Calibra Céram
##### Group
**Description:** Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement

Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
**ID:** OG001
**Title:** Hand Polished, Calibra Universal
#### Outcome Measure 4
**Description:** Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth, or "1" if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below.
**Parameter Type:** NUMBER
**Population Description:** number of crowns
**Reporting Status:** POSTED
**Time Frame:** from delivery of the crown up to 3 years
**Title:** Margin Staining
**Type:** SECONDARY
**Type Units Analyzed:** Teeth
**Unit of Measure:** crowns
##### Group
**Description:** Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement

Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
**ID:** OG000
**Title:** Glazed Fired, Calibra Céram
##### Group
**Description:** Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement

Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
**ID:** OG001
**Title:** Hand Polished, Calibra Universal
### Participant Flow Module
#### Group
**Description:** Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement

Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
**ID:** FG000
**Title:** Glazed Fired, Calibra Céram
#### Group
**Description:** Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement

Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
**ID:** FG001
**Title:** Hand Polished, Calibra Universal
#### Period
**Title:** Baseline
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
**Number of Units:** 50
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 32
**Number of Units:** 50
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
**Number of Units:** 50
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 32
**Number of Units:** 50
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Number of Units:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Number of Units:** 0
#### Period
**Title:** 6 Months
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
**Number of Units:** 50
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 32
**Number of Units:** 50
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
**Number of Units:** 50
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 32
**Number of Units:** 50
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Number of Units:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Number of Units:** 0
#### Period
**Title:** 1 Year
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
**Number of Units:** 50
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 32
**Number of Units:** 50
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
**Number of Units:** 50
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 32
**Number of Units:** 50
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Number of Units:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Number of Units:** 0
#### Period
**Title:** 2 Years
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
**Number of Units:** 50
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 32
**Number of Units:** 50
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 40
**Number of Units:** 49
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 32
**Number of Units:** 50
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
**Number of Units:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Number of Units:** 0
#### Period
**Title:** 3 Years
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
**Number of Units:** 50
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 32
**Number of Units:** 50
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
**Number of Units:** 50
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 31
**Number of Units:** 49
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Number of Units:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
**Number of Units:** 1
**Pre-Assignment Details:** Recall at 5 years not funded by sponsor, therefore data not collected up to 5 years
**Type Units Analyzed:** tooth
**Has Results:** True