Trial Outcomes & Findings for Bisphenol A in Saliva and Urine Related to Placement of Dental Composites (NCT NCT02575118)

Results Overview

Estimated bisphenol A (BPA) concentration (ng ml-1) in saliva

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

1 week

Results posted on

2023-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Group Patients in need of at least one dental restoration, involving two or more tooth surfaces, with a polymer-based restorative material were informed about the study by their dental hygienist or dentist at their regular dental examination at two public dental clinics in Bergen, Norway.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=20 Participants Patients in need of at least one dental restoration, involving two or more tooth surfaces, with a polymer-based restorative material were informed about the study by their dental hygienist or dentist at their regular dental examination at two public dental clinics in Bergen, Norway.
Age, Continuous	23.4 years STANDARD_DEVIATION 5.7 • n=20 Participants
Sex: Female, Male Female	13 Participants n=20 Participants
Sex: Female, Male Male	7 Participants n=20 Participants
Region of Enrollment Norway	20 participants n=20 Participants
Education	13.8 years STANDARD_DEVIATION 1.8 • n=20 Participants
Job handling receipts	5 Number of Participants Handling Receipts n=20 Participants

PRIMARY outcome

Timeframe: 1 week

Population: n=19 at 1 week follow up (since mixed effects models were used all available data, also data for participants with missing observations at some time points, were included in the model \[see: Rabe-Hesketh and Skrondal. Multilevel and Longitudinal Modeling Using Stata, Volume I, Third Edition. 2012, page 279\])

Estimated bisphenol A (BPA) concentration (ng ml-1) in saliva

Outcome measures

Outcome measures
Measure	Treatment Group n=20 Participants Patients in need of at least one dental restoration, involving two or more tooth surfaces, with a polymer-based restorative material were informed about the study by their dental hygienist or dentist at their regular dental examination at two public dental clinics in Bergen, Norway.
Concentration of Bisphenol A in Saliva	0.25 ng/ml Interval 0.17 to 0.33

PRIMARY outcome

Timeframe: 1 week

Population: n=19 at 1 week follow up (since mixed effects models were used all available data, also data for participants with missing observations at some time points, were included in the model \[see: Rabe-Hesketh and Skrondal. Multilevel and Longitudinal Modeling Using Stata, Volume I, Third Edition. 2012, page 279\])

Estimated bisphenol A (BPA) concentration (ng ml-1) in urine

Outcome measures

Outcome measures
Measure	Treatment Group n=20 Participants Patients in need of at least one dental restoration, involving two or more tooth surfaces, with a polymer-based restorative material were informed about the study by their dental hygienist or dentist at their regular dental examination at two public dental clinics in Bergen, Norway.
Concentration of Bisphenol A in Urine	1.99 ng/ml Interval 0.97 to 3.0

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Trine Lise Lundekvam Berge

NORCE

Phone: +47 56 10 72 12

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place