Trial Outcomes & Findings for Clinical Study of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations (NCT NCT03764059)
NCT ID: NCT03764059
Last Updated: 2023-07-21
Results Overview
According to Clinical Trial Guideline for Polymer-based Dental Restorative Materials (YY/T 0990-2015), the clinically acceptable definition of restoration at 1 year after replacement was as follows: The retention and fracture score of restoration at 1 year after replacement was A; the marginal fracture, the appearance and the marginal adaptationof restoration was A or B.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
1 Year after restoration
Results posted on
2023-07-21
Participant Flow
Participant milestones
| Measure |
Investigational Device/Experimental Group: Filtek™ Bulk Fill Posterior Restorative
The investigational device, Filtek™ Bulk Fill Posterior Restorative, was used for class 1 or 2 restorative in experimental group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.
|
Control Device/Control Group: Filtek™ Z350XT Universal Restorative
The control device, Filtek™ Z350XT Universal Restorative, which was approved by CFDA in 2010 and has been in the market for 5 years with some validated clinical data, was used for class 1 or 2 restorative in control group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
|
Overall Study
COMPLETED
|
120
|
120
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Interventional
n=120 Participants
The experimental group (Filtek Bulk fill posterior restoration) .After restoration,subjects will return to site for follow up visit at 1 week and 1 year postoperative for further clinical assessments.
Filtek bulk fill posterior restoration: The subjects will be assigned to either the investigational product (Filtek Bulk ) or the control product (Z350XT) per web-based randomization system.
Immediately after restoration placement, at 1 week and 1 year postoperative, two evaluators from each site will perform an independent clinical assessment.
|
Observational
n=120 Participants
The control group (Filtek™ Z350XT Universal Restorative which was approved by CFDA in 2010 and has been in the market for 5 years with some validated clinical data).After restoration,subjects will return to the site for follow up visits at 1 week and 1 year postoperative for for further clinical assessments.
Filtek™ Z350XT Universal Restorative: Filtek™ Z350XT Universal Restorative (Z350 XT) will serve as the control in this study.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.97 years
STANDARD_DEVIATION 6.65 • n=120 Participants
|
28.12 years
STANDARD_DEVIATION 7.76 • n=120 Participants
|
28.05 years
STANDARD_DEVIATION 10.22 • n=240 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=120 Participants
|
81 Participants
n=120 Participants
|
165 Participants
n=240 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=120 Participants
|
39 Participants
n=120 Participants
|
75 Participants
n=240 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Clinical diagnosis of caries
|
119 participants
n=120 Participants
|
120 participants
n=120 Participants
|
239 participants
n=240 Participants
|
PRIMARY outcome
Timeframe: 1 Year after restorationAccording to Clinical Trial Guideline for Polymer-based Dental Restorative Materials (YY/T 0990-2015), the clinically acceptable definition of restoration at 1 year after replacement was as follows: The retention and fracture score of restoration at 1 year after replacement was A; the marginal fracture, the appearance and the marginal adaptationof restoration was A or B.
Outcome measures
| Measure |
Investigational Device/Experimental Group: Filtek™ Bulk Fill Posterior Restorative
n=120 Participants
The investigational device, Filtek™ Bulk Fill Posterior Restorative, was used for class 1 or 2 restorative in experimental group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.
|
Control Device/Control Group: Filtek™ Z350XT Universal Restorative
n=120 Participants
The control device, Filtek™ Z350XT Universal Restorative, which was approved by CFDA in 2010 and has been in the market for 5 years with some validated clinical data, was used for class 1 or 2 restorative in control group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.
|
|---|---|---|
|
Clinical Acceptance Rate of Restoration at 1 Year After Replacement
Acceptable restoration
|
120 Participants
|
119 Participants
|
|
Clinical Acceptance Rate of Restoration at 1 Year After Replacement
unacceptable restoration
|
0 Participants
|
1 Participants
|
Adverse Events
Investigational Device/Experimental Group: Filtek™ Bulk Fill Posterior Restorative
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Control Device/Control Group: Filtek™ Z350XT Universal Restorative
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Investigational Device/Experimental Group: Filtek™ Bulk Fill Posterior Restorative
n=120 participants at risk
The investigational device, Filtek™ Bulk Fill Posterior Restorative, was used for class 1 or 2 restorative in experimental group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.
|
Control Device/Control Group: Filtek™ Z350XT Universal Restorative
n=120 participants at risk
The control device, Filtek™ Z350XT Universal Restorative, which was approved by CFDA in 2010 and has been in the market for 5 years with some validated clinical data, was used for class 1 or 2 restorative in control group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
4.2%
5/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
6.7%
8/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Non-target caries
|
16.7%
20/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
4.2%
5/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Post-operative tooth sensitivity
|
6.7%
8/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
2.5%
3/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Impacted wisdom teeth
|
5.0%
6/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
5.8%
7/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Wisdom tooth extraction
|
2.5%
3/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
1.7%
2/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Irregular dentition
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
1.7%
2/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Tooth sensitivity during operation
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Chronic periodontitis
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
1.7%
2/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Chronic periapical periodontitis
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Plaque-induced gingivitis
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Gum bleeding on the target side
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Gum pain on the target side
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Mild redness and swelling of gingival margin on the target side
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Pain of buccal mucosa of target teeth
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Mucosal ulceration of target teeth
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Radiolucent area of root tip of target teeth
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Malaise of occlusion of target teeth
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Spontaneous discomfort of target teeth
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Edge caries of non-target teeth
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Non-target residual root
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Product Issues
Falling of filling material of non-target teeth
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Pericoronitis of non-target teeth
|
2.5%
3/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Secondary Caries of non-target teeth
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Secondary Caries of non-target teeth (after endodontic treatment)
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Reversible pulpitis of non-target teeth
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Chronic pulpitis of non-target teeth
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Infections and infestations
Acute attack of chronic pulpitis of non-target teeth
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Non-target caries, gingivitis
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Sensitivity of non-target teeth after operation
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
1.7%
2/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Microdontia of non-target teeth
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Wedge-shaped defect of non-target teeth
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
1.7%
2/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Pulpitis of non-target teeth
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Dental defect of non-target teeth
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Gingival ulcer of non-target teeth
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Surgical and medical procedures
Treatment of non-target teeth
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Mild redness and swelling of gingival margin of non-target teeth
|
1.7%
2/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Recurrent oral ulcer
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Generalized chronic periodontitis
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Infections and infestations
Acute laryngitis
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Pain in the injection point of buccal anesthetics
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Redness and swelling of gingiva near middle palatal side
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Skin and subcutaneous tissue disorders
Chestnut eruption
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Surgical and medical procedures
Other Treatments
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Injury, poisoning and procedural complications
Gingival margin of palatine side injured by rubber dam
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Gastrointestinal disorders
Gingival edema
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Musculoskeletal and connective tissue disorders
Right ankle fracture
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
|
Eye disorders
Hordeolum
|
0.83%
1/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
0.00%
0/120 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER