Trial Outcomes & Findings for Comparative Study of Experimental Dental Adhesive With and Without Phosphoric Acid Pretreatment (NCT NCT02071953)
NCT ID: NCT02071953
Last Updated: 2022-11-28
Results Overview
The color match will be assessed clinically according to Ryge (1973)\* for matching with adjacent teeth and stability of color matching over time. Assessments will be done to the following criteria: Alpha= Restoration matches adjacent tooth structure in shade and/or translucency. Bravo= Mismatch in shade and/or translucency is within normal range of tooth shades. Charlie= Mismatch in shade and/or translucency is outside normal range of tooth shades. \*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
COMPLETED
NA
37 participants
Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
2022-11-28
Participant Flow
Unit of analysis: teeth
Participant milestones
| Measure |
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration
Experimental adhesive without phosphoric acid in posterior restoration
|
Experimental Adhesive w/ Phosphoric Acid in Post Restoration
Experimental adhesive with phosphoric acid in post restoration
|
|---|---|---|
|
Overall Study
STARTED
|
35 53
|
35 54
|
|
Overall Study
COMPLETED
|
18 30
|
21 34
|
|
Overall Study
NOT COMPLETED
|
17 23
|
14 20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Study of Experimental Dental Adhesive With and Without Phosphoric Acid Pretreatment
Baseline characteristics by cohort
| Measure |
Experimental: Adhesive With and Without Acid Pretreatment
n=107 teeth
Experimental adhesive with and without phosphoric acid in posterior restoration
|
|---|---|
|
Age, Categorical
<=18 years
|
0 teeth
n=60 teeth
|
|
Age, Categorical
Between 18 and 65 years
|
107 teeth
n=60 teeth
|
|
Age, Categorical
>=65 years
|
0 teeth
n=60 teeth
|
|
Sex/Gender, Customized
Female
|
20 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
17 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.Population: This is the total number of participants remaining at the end of the study who completed the 18 month follow-up. 22 participants presented for the 18 month evaluation. Most participants had subject teeth in both arms of the study. The reporting below is on the number of teeth, not subjects.
The color match will be assessed clinically according to Ryge (1973)\* for matching with adjacent teeth and stability of color matching over time. Assessments will be done to the following criteria: Alpha= Restoration matches adjacent tooth structure in shade and/or translucency. Bravo= Mismatch in shade and/or translucency is within normal range of tooth shades. Charlie= Mismatch in shade and/or translucency is outside normal range of tooth shades. \*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Outcome measures
| Measure |
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (Baseline)
n=53 teeth
Experimental adhesive without phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (Baseline)
n=54 teeth
Experimental adhesive with phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (6-month)
n=50 teeth
Experimental adhesive without phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (6-month)
n=52 teeth
Experimental adhesive with phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (18-month)
n=30 teeth
Experimental adhesive without phosphoric acid in posterior restoration (18-month)
|
Experimental Adhesive w Phosphoric Acid in Posterior Restoration (18-month)
n=34 teeth
Experimental adhesive with phosphoric acid in posterior restoration (18-month)
|
|---|---|---|---|---|---|---|
|
Color Match
Charlie
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
|
Color Match
Alpha
|
53 teeth
|
54 teeth
|
50 teeth
|
52 teeth
|
30 teeth
|
34 teeth
|
|
Color Match
Bravo
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 18 months. Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.Population: This is the total number of participants remaining at the end of the study who completed the 18 month follow-up. 22 participants presented for the 18 month evaluation. Most participants had subject teeth in both arms of the study. The reporting below is on the number of teeth, not subjects.
Marginal discoloration will be assessed clinically according to Ryge (1973)\* over time. Assessments will be done to the following criteria: Alpha= No visual evidence of marginal discoloration. Bravo= Marginal discoloration present but has not penetrated in a pulpal direction. Charlie= Marginal discoloration has penetrated in a pulpal direction. \*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Outcome measures
| Measure |
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (Baseline)
n=53 teeth
Experimental adhesive without phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (Baseline)
n=54 teeth
Experimental adhesive with phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (6-month)
n=50 teeth
Experimental adhesive without phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (6-month)
n=52 teeth
Experimental adhesive with phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (18-month)
n=30 teeth
Experimental adhesive without phosphoric acid in posterior restoration (18-month)
|
Experimental Adhesive w Phosphoric Acid in Posterior Restoration (18-month)
n=34 teeth
Experimental adhesive with phosphoric acid in posterior restoration (18-month)
|
|---|---|---|---|---|---|---|
|
Marginal Discoloration
Alpha
|
53 teeth
|
54 teeth
|
50 teeth
|
52 teeth
|
27 teeth
|
34 teeth
|
|
Marginal Discoloration
Bravo
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
3 teeth
|
0 teeth
|
|
Marginal Discoloration
Charlie
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 18 months. Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.Population: This is the total number of participants remaining at the end of the study who completed the 18 month follow-up. 22 participants presented for the 18 month evaluation. Most participants had subject teeth in both arms of the study. The reporting below is on the number of teeth, not subjects.
Change in marginal integrity will be assessed clinically according to Ryge (1973)\* over time. Assessments will be done to the following criteria: A= Explorer does not catch or slight catch with no visible crevice. B= Explorer catches and crevice is visible but no exposure of dentin or base. C= Explorer penetrates crevice and defect extended to amelo-dentinal junction. D= Restoration is fractured, mobile, or missing in part or in toto. \*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Outcome measures
| Measure |
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (Baseline)
n=53 teeth
Experimental adhesive without phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (Baseline)
n=54 teeth
Experimental adhesive with phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (6-month)
n=50 teeth
Experimental adhesive without phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (6-month)
n=52 teeth
Experimental adhesive with phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (18-month)
n=30 teeth
Experimental adhesive without phosphoric acid in posterior restoration (18-month)
|
Experimental Adhesive w Phosphoric Acid in Posterior Restoration (18-month)
n=34 teeth
Experimental adhesive with phosphoric acid in posterior restoration (18-month)
|
|---|---|---|---|---|---|---|
|
Marginal Integrity
Alpha
|
53 teeth
|
53 teeth
|
49 teeth
|
52 teeth
|
26 teeth
|
34 teeth
|
|
Marginal Integrity
Bravo
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
3 teeth
|
0 teeth
|
|
Marginal Integrity
Charlie
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
|
Marginal Integrity
Delta
|
0 teeth
|
1 teeth
|
1 teeth
|
0 teeth
|
1 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.Population: This is the total number of participants remaining at the end of the study who completed the 18 month follow-up. 22 participants presented for the 18 month evaluation. Most participants had subject teeth in both arms of the study. The reporting below is on the number of teeth, not subjects.
Change in presence of secondary dental caries will be assessed clinically according to Ryge (1973)\* over time. Assessments will be done to the following criteria: A= No caries present. D= Caries present associated with the restoration. \*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed. Note: Secondary caries is a categorical, dichotomous variable, i.e. there is caries or not. This was assessed clinically and radiographically by a trained professional (dentist).
Outcome measures
| Measure |
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (Baseline)
n=53 teeth
Experimental adhesive without phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (Baseline)
n=54 teeth
Experimental adhesive with phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (6-month)
n=50 teeth
Experimental adhesive without phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (6-month)
n=52 teeth
Experimental adhesive with phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (18-month)
n=30 teeth
Experimental adhesive without phosphoric acid in posterior restoration (18-month)
|
Experimental Adhesive w Phosphoric Acid in Posterior Restoration (18-month)
n=34 teeth
Experimental adhesive with phosphoric acid in posterior restoration (18-month)
|
|---|---|---|---|---|---|---|
|
Presence of Secondary Dental Caries (Cavities)
Alpha
|
53 teeth
|
54 teeth
|
50 teeth
|
52 teeth
|
30 teeth
|
34 teeth
|
|
Presence of Secondary Dental Caries (Cavities)
Delta
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.Population: This is the total number of participants remaining at the end of the study who completed the 18 month follow-up. 22 participants presented for the 18 month evaluation. Most participants had subject teeth in both arms of the study. The reporting below is on the number of teeth, not subjects.
The restoration will be assessed clinically according to Ryge (1973)\* for presence of fractures over time. Assessments will be done to the following criteria: A= Smooth restoration surface with no irregularities. B= Slightly rough or pitted restoration surface. Can be refinished. C= Deeply pitted or grooved (not related to anatomy) restoration finish. Can not be refinished. D= Restoration surface is fractured or flaking. \*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Outcome measures
| Measure |
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (Baseline)
n=53 teeth
Experimental adhesive without phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (Baseline)
n=54 teeth
Experimental adhesive with phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (6-month)
n=50 teeth
Experimental adhesive without phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (6-month)
n=52 teeth
Experimental adhesive with phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (18-month)
n=30 teeth
Experimental adhesive without phosphoric acid in posterior restoration (18-month)
|
Experimental Adhesive w Phosphoric Acid in Posterior Restoration (18-month)
n=34 teeth
Experimental adhesive with phosphoric acid in posterior restoration (18-month)
|
|---|---|---|---|---|---|---|
|
Presence of Restoration Fractures (Localized or Bulk)
Alpha
|
52 teeth
|
53 teeth
|
47 teeth
|
52 teeth
|
27 teeth
|
34 teeth
|
|
Presence of Restoration Fractures (Localized or Bulk)
Bravo
|
0 teeth
|
0 teeth
|
2 teeth
|
0 teeth
|
2 teeth
|
0 teeth
|
|
Presence of Restoration Fractures (Localized or Bulk)
Charlie
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
|
Presence of Restoration Fractures (Localized or Bulk)
Delta
|
1 teeth
|
1 teeth
|
1 teeth
|
0 teeth
|
1 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.Population: This is the total number of participants remaining at the end of the study who completed the 18 month follow-up. 22 participants presented for the 18 month evaluation. Most participants had subject teeth in both arms of the study. The reporting below is on the number of teeth, not subjects.
Patient will be interviewed to assess post-operative sensitivity according to the following criteria: A= No sensitivity. B= Mild sensitivity. C= Moderate sensitivity with no restoration replacement required. D= Sever sensitivity. Replacement of restoration is required. Tooth sensitivity will be assessed at baseline and each follow-up appointment using cold thermal test (Endo-Ice, Hygienic) and Electric Pulp Test (EPT) when indicated.
Outcome measures
| Measure |
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (Baseline)
n=53 teeth
Experimental adhesive without phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (Baseline)
n=54 teeth
Experimental adhesive with phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (6-month)
n=50 teeth
Experimental adhesive without phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (6-month)
n=52 teeth
Experimental adhesive with phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (18-month)
n=30 teeth
Experimental adhesive without phosphoric acid in posterior restoration (18-month)
|
Experimental Adhesive w Phosphoric Acid in Posterior Restoration (18-month)
n=34 teeth
Experimental adhesive with phosphoric acid in posterior restoration (18-month)
|
|---|---|---|---|---|---|---|
|
Post-operative Sensitivity
Alpha
|
51 teeth
|
53 teeth
|
50 teeth
|
52 teeth
|
30 teeth
|
34 teeth
|
|
Post-operative Sensitivity
Bravo
|
2 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
|
Post-operative Sensitivity
Charlie
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
|
Post-operative Sensitivity
Delta
|
0 teeth
|
1 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.Population: This is the total number of participants remaining at the end of the study who completed the 18 month follow-up. 22 participants presented for the 18 month evaluation. Most participants had subject teeth in both arms of the study. The reporting below is on the number of teeth, not subjects.
The change in surface condition of restoration will be assessed clinically according to Ryge (1973)\* over time. Assessments will be done to the following criteria: A= Restoration is continuous with existing anatomic form. B= Restoration is discontinuous with existing anatomic form but missing material is not sufficient to expose dentin or lining. C= Sufficient restorative material is lost to expose dentin. \*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Outcome measures
| Measure |
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (Baseline)
n=53 teeth
Experimental adhesive without phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (Baseline)
n=54 teeth
Experimental adhesive with phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (6-month)
n=50 teeth
Experimental adhesive without phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (6-month)
n=52 teeth
Experimental adhesive with phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (18-month)
n=30 teeth
Experimental adhesive without phosphoric acid in posterior restoration (18-month)
|
Experimental Adhesive w Phosphoric Acid in Posterior Restoration (18-month)
n=34 teeth
Experimental adhesive with phosphoric acid in posterior restoration (18-month)
|
|---|---|---|---|---|---|---|
|
Surface Condition of Restoration
Charlie
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
0 teeth
|
|
Surface Condition of Restoration
AlphaB
|
53 teeth
|
54 teeth
|
47 teeth
|
52 teeth
|
29 teeth
|
34 teeth
|
|
Surface Condition of Restoration
Bravo
|
0 teeth
|
0 teeth
|
3 teeth
|
0 teeth
|
1 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.Population: This is the total number of participants remaining at the end of the study who completed the 18 month follow-up. 22 participants presented for the 18 month evaluation. Most participants had subject teeth in both arms of the study. The reporting below is on the number of teeth, not subjects. Twenty-two (22) of the restorations were Class I and have no interaction with the gingival tissue and therefore were not scored. Scores below are for the remaining 42 Class II restorations.
Patient's gingiva will be assessed clinically according to Ryge (1973)\* over time. Assessments will be done to the following criteria: 0 = Normal gingiva. 1. = Mild inflammation, slight change in color, slight edema, no bleeding upon probing. 2. = Moderate inflammation, redness; edema and glazing; bleeding upon palpation. 3. = Severe inflammation, marked redness and edema, ulceration, tendency to spontaneous bleeding. * As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed. Note: At 6 months data was not reported. At Baseline, all patients presented a score of 0. Any patient with a score greater than zero would have been excluded at baseline. Patients who received Class I restorations were not assessed as these restorations are limited to the chewing surface and not related to the health of gums.
Outcome measures
| Measure |
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (Baseline)
n=22 teeth
Experimental adhesive without phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (Baseline)
n=20 teeth
Experimental adhesive with phosphoric acid in posterior restoration (Baseline)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (6-month)
Experimental adhesive without phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/ Phosphoric Acid in Posterior Restoration (6-month)
Experimental adhesive with phosphoric acid in posterior restoration (6-month)
|
Experimental Adhesive w/Out Phosphoric Acid in Posterior Restoration (18-month)
Experimental adhesive without phosphoric acid in posterior restoration (18-month)
|
Experimental Adhesive w Phosphoric Acid in Posterior Restoration (18-month)
Experimental adhesive with phosphoric acid in posterior restoration (18-month)
|
|---|---|---|---|---|---|---|
|
Gingival Inflammation Index
0
|
12 teeth
|
9 teeth
|
—
|
—
|
—
|
—
|
|
Gingival Inflammation Index
1
|
9 teeth
|
11 teeth
|
—
|
—
|
—
|
—
|
|
Gingival Inflammation Index
2
|
1 teeth
|
0 teeth
|
—
|
—
|
—
|
—
|
|
Gingival Inflammation Index
3
|
0 teeth
|
0 teeth
|
—
|
—
|
—
|
—
|
Adverse Events
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place