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Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone

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ClinicalTrials.gov Identifier: NCT02154581
Recruitment Status : Completed
First Posted : June 3, 2014
Results First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
ITI International Team for Implantology, Switzerland
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Jaw, Edentulous, Partially
Acquired Absence of Single Tooth
Intervention Device: SLActive implant
Enrollment 41
Recruitment Details The recruitment started in January 2013 and ended in November 2016. All patient were recruited at the University of Texas Health San Antonio, Department of Periodontics.
Pre-assignment Details No patient was excluded prior to group assignment.
Arm/Group Title Type 1 Implant and Thick Biotype Type 1 Implant and Thin Biotype
Hide Arm/Group Description

In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.

SLActive implant

In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.

SLActive implant

Period Title: Overall Study
Started 21 20
Completed 14 12
Not Completed 7 8
Reason Not Completed
Lost to Follow-up             7             8
Arm/Group Title Type 1 Implant and Thick Biotype Type 1 Implant and Thin Biotype Total
Hide Arm/Group Description

In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.

SLActive implant

In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.

SLActive implant

Total of all reporting groups
Overall Number of Baseline Participants 14 12 26
Hide Baseline Analysis Population Description
Each patient received one dental implant which was included in the analysis.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Participants over 18 years of age Number Analyzed 14 participants 12 participants 26 participants
14
 100.0%
12
 100.0%
26
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 26 participants
Female
8
  57.1%
10
  83.3%
18
  69.2%
Male
6
  42.9%
2
  16.7%
8
  30.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 12 participants 26 participants
14 12 26
1.Primary Outcome
Title Mid Facial Mucosal Level at Implant Site
Hide Description Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12 months after crown delivery.
Time Frame Change from Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Type 1 Implant and Thick Biotype Type 1 Implant and Thin Biotype
Hide Arm/Group Description:

In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.

SLActive implant

In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.

SLActive implant

Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: mm
0.36  (1.29) 0.49  (1.27)
2.Secondary Outcome
Title PES/WES (Pink Esthetic Score, White Esthetic Score).
Hide Description Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 12 months after crown delivery. The PES (Pink Esthetic Score) and WES (White Esthetic Score) scales are 10 point scales, made up of 5 categories, each with a 2 point value. Each category is scored out of 2, and the scores totaled to give an optimal score out of 10, and then the two scores (PES and WES) added to give a total score out of 20, with 20 being the highest possible score (best outcome) and 0 being the worst outcome.
Time Frame Approximately 1 year after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Type 1 Implant and Thick Biotype Type 1 Implant and Thin Biotype
Hide Arm/Group Description:

In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.

SLActive implant

In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.

SLActive implant

Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
12.07  (2.87) 11.64  (3.22)
3.Secondary Outcome
Title Probing Depth
Hide Description Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at baseline, 3 and 12 months after crown delivery. The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3 mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported.
Time Frame Up to 1 year after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Type 1 Implant and Thick Biotype Type 1 Implant and Thin Biotype
Hide Arm/Group Description:

In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.

SLActive implant

In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.

SLActive implant

Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: mm
Baseline at Crown delivery (Mesial measurement) 3.14  (0.77) 2.50  (1.24)
3 months (Mesial) 3.21  (0.70) 2.92  (1.16)
12 months (Mesial) 3.29  (0.83) 2.42  (1.31)
Baseline at Crown Delivery (Distal Measurement) 3.43  (0.85) 2.33  (0.49)
3 months (distal) 3.43  (1.02) 2.08  (0.51)
12 months (distal) 3.36  (1.01) 2.42  (0.51)
Baseline at Crown Delivery (Buccal Measurement) 2.93  (1.14) 1.75  (0.75)
3 months (Buccal) 3.07  (1.27) 1.75  (0.75)
12 months (Buccal) 3.21  (1.58) 1.92  (0.79)
Baseline at Crown Delivery (Proximal measurement) 2.64  (0.50) 2.00  (0.85)
3 months (proximal) 2.79  (0.80) 1.67  (0.78)
12 months (proximal) 2.21  (0.70) 1.75  (0.97)
4.Secondary Outcome
Title Modified Plaque Index
Hide Description Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery. Measurement of amount of plaque build-up on teeth, using a scale of 0 (no plaque detection), to 3 (an abundance of soft matter). The scores are totaled and a mean score reported.
Time Frame Up to 1 year after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Type 1 Implant and Thick Biotype Type 1 Implant and Thin Biotype
Hide Arm/Group Description:

In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.

SLActive implant

In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.

SLActive implant

Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline crown delivery (Mesial measurement) 0.29  (0.61) 0.42  (1.00)
3 months (Mesial) 0.36  (0.63) 0.08  (0.29)
12 months (Mesial) 0.50  (0.76) 0.00  (0.00)
Baseline at Crown Delivery (Distal Measurement) 0.36  (0.50) 0.17  (0.58)
3 months (distal) 0.29  (0.61) 0.17  (0.39)
12 months (distal) 0.29  (0.61) 0.08  (0.29)
Baseline at Crown Delivery (Buccal Measurement) 0.14  (0.36) 0.08  (0.29)
3 months (Buccal) 0.14  (0.53) 0.00  (0.00)
12 months (Buccal) 0.29  (0.47) 0.00  (0.00)
Baseline at Crown Delivery (Proximal measurement) 0.36  (0.50) 0.00  (0.00)
3 months (proximal) 0.07  (0.27) 0.00  (0.00)
12 months (proximal) 0.21  (0.58) 0.00  (0.00)
5.Secondary Outcome
Title Modified Bleeding Index
Hide Description Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery. Bleeding from the gums is measured on probing the gum and measured on scale of 0 to 5, with 0 being the best outcome, with no bleeding, and 5 being the worst outcome, with spontaneous bleeding. The scores are totaled and a mean score reported.
Time Frame Up to 1 year after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Type 1 Implant and Thick Biotype Type 1 Implant and Thin Biotype
Hide Arm/Group Description:

In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.

SLActive implant

In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.

SLActive implant

Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline crown delivery (Mesial measurement) 0.43  (0.65) 0.00  (0.00)
3 months (Mesial) 0.29  (0.47) 0.08  (0.29)
12 months (Mesial) 0.29  (0.47) 0.08  (0.29)
Baseline at Crown Delivery (Distal Measurement) 0.43  (0.51) 0.17  (0.39)
3 months (distal) 0.14  (0.36) 0.08  (0.29)
12 months (distal) 0.29  (0.47) 0.17  (0.39)
Baseline at Crown Delivery (Buccal Measurement) 0.21  (0.58) 0.17  (0.39)
3 months (Buccal) 0.36  (0.50) 0.25  (0.62)
12 months (Buccal) 0.64  (0.9) 0.00  (0.00)
Baseline at Crown Delivery (Proximal measurement) 0.14  (0.36) 0.00  (0.00)
3 months (proximal) 0.36  (0.50) 0.00  (0.00)
12 months (proximal) 0.29  (0.47) 0.00  (0.00)
6.Secondary Outcome
Title Radiographic Bone Level
Hide Description Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at baseline 3, and 12 months after crown delivery. Radiographic bone measurements recorded following final restoration placement (baseline), after 3 and 12 months of loading, and change between these time points. A positive value indicates bone loss and a negative value indicates bone gain. BIC (Bone implant contact)= Distance from implant shoulder to first bone to implant contact.
Time Frame Up to 1 year after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Type 1 Implant and Thick Biotype Type 1 Implant and Thin Biotype
Hide Arm/Group Description:

In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.

SLActive implant

In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.

SLActive implant

Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: mm
Baseline to 3 months BIC (Mesial measurement) -0.04  (0.08) 0.02  (0.05)
3 to 12 months BIC (Mesial) 0.05  (0.10) 0.04  (0.10)
Baseline to 12 months BIC (Mesial) 0.00  (0.13) 0.06  (0.12)
Baseline to 3 months BIC (Distal Measurement) -0.02  (0.13) -0.04  (0.12)
3 to 12 months BIC (distal) -0.07  (0.12) 0.05  (0.08)
Baseline to 12 months BIC (distal) -0.08  (0.15) 0.01  (0.12)
Time Frame Research related adverse events were collected throughout the study period, up to 1 year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Type 1 Implant and Thick Biotype Type 1 Implant and Thin Biotype
Hide Arm/Group Description

In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.

SLActive implant

In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.

SLActive implant

All-Cause Mortality
Type 1 Implant and Thick Biotype Type 1 Implant and Thin Biotype
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/12 (0.00%) 
Hide Serious Adverse Events
Type 1 Implant and Thick Biotype Type 1 Implant and Thin Biotype
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Type 1 Implant and Thick Biotype Type 1 Implant and Thin Biotype
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/12 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Research Compliance Coordinator-Senior
Organization: UT Health San Antonio
Phone: 210-567-8554
EMail: NijlandK@uthscsa.edu
Layout table for additonal information
Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02154581    
Other Study ID Numbers: ITI 799_2011
HSC20130085H ( Other Identifier: UTHSCSA IRB )
First Submitted: May 30, 2014
First Posted: June 3, 2014
Results First Submitted: April 11, 2019
Results First Posted: July 9, 2019
Last Update Posted: July 9, 2019