Trial Outcomes & Findings for Clinical Evaluation of Enamel Microhardness Using Tooth Whitening Agents (NCT NCT07165366)

Results Overview

Vickers hardness kg f/mm2 Baseline measurements: two nonbleached bicuspids in the dental arches. One first or second bicuspid in the maxillary arch was bleached with At-Home 10% Carbamide Peroxide and the contralateral bicuspid served as the control in the maxillary arch. One first or second bicuspid in the mandibular arch was bleached with In-Office 40% Hydrogen Peroxide and the other contralateral bicuspid in the mandibular arch served as the control. The control bicuspids served as the baseline measurements.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

one month

Results posted on

2026-01-20

Participant Flow

Patients at the Postgraduate Department of Orthodontics at the Universidad Intercontinental were invited to participate in the study. The recruitment period began on May 1,2024

Participants were excluded who did not have prominent facial surfaces on a bicuspid in each of their four quadrants.

Unit of analysis: teeth

Participant milestones

Participant milestones
Measure	Control Teeth in patients that were left untreated during the trial. (2 units)	OP 10% CP Teeth in patients that were exposed to 10% Carbamide Peroxide over a consecutive 14-day period. (1 unit)	OP 40% HP Teeth in patients that were exposed to 40% Hydrogen Peroxide in a single session.(1 unit)
Overall Study STARTED	40 80	40 40	40 40
Overall Study COMPLETED	40 80	40 40	40 40
Overall Study NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The total of patients was 40. Being 4 premolars analyzed for each patient. 2 teeth served as control group without treatment, 1 for OP 10% CP; and 1 OP 40% HP.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=80 teeth Untreated teeth	OP 10% CP n=40 teeth Teeth treated with 10% Carbamide Peroxide for 14 days	OP 40% HP n=40 teeth Teeth treated once with 40% Hydrogen Peroxide	Total n=160 teeth Total of all reporting groups
Age, Continuous	18.7 years n=40 Participants • The total of patients was 40. Being 4 premolars analyzed for each patient. 2 teeth served as control group without treatment, 1 for OP 10% CP; and 1 OP 40% HP.	18.7 years n=40 Participants • The total of patients was 40. Being 4 premolars analyzed for each patient. 2 teeth served as control group without treatment, 1 for OP 10% CP; and 1 OP 40% HP.	18.7 years n=40 Participants • The total of patients was 40. Being 4 premolars analyzed for each patient. 2 teeth served as control group without treatment, 1 for OP 10% CP; and 1 OP 40% HP.	18.7 years n=40 Participants • The total of patients was 40. Being 4 premolars analyzed for each patient. 2 teeth served as control group without treatment, 1 for OP 10% CP; and 1 OP 40% HP.
Sex: Female, Male Female	52 teeth n=80 teeth • The total of patients was 40. Being 4 premolars analyzed for each patient. 2 teeth served as control group without treatment, 1 for OP 10% CP; and 1 OP 40% HP. The unit of measure was Vickers hardness of each teeth, measured on the buccal surfaces.	26 teeth n=40 teeth • The total of patients was 40. Being 4 premolars analyzed for each patient. 2 teeth served as control group without treatment, 1 for OP 10% CP; and 1 OP 40% HP. The unit of measure was Vickers hardness of each teeth, measured on the buccal surfaces.	26 teeth n=40 teeth • The total of patients was 40. Being 4 premolars analyzed for each patient. 2 teeth served as control group without treatment, 1 for OP 10% CP; and 1 OP 40% HP. The unit of measure was Vickers hardness of each teeth, measured on the buccal surfaces.	104 teeth n=160 teeth • The total of patients was 40. Being 4 premolars analyzed for each patient. 2 teeth served as control group without treatment, 1 for OP 10% CP; and 1 OP 40% HP. The unit of measure was Vickers hardness of each teeth, measured on the buccal surfaces.
Sex: Female, Male Male	28 teeth n=80 teeth • The total of patients was 40. Being 4 premolars analyzed for each patient. 2 teeth served as control group without treatment, 1 for OP 10% CP; and 1 OP 40% HP. The unit of measure was Vickers hardness of each teeth, measured on the buccal surfaces.	14 teeth n=40 teeth • The total of patients was 40. Being 4 premolars analyzed for each patient. 2 teeth served as control group without treatment, 1 for OP 10% CP; and 1 OP 40% HP. The unit of measure was Vickers hardness of each teeth, measured on the buccal surfaces.	14 teeth n=40 teeth • The total of patients was 40. Being 4 premolars analyzed for each patient. 2 teeth served as control group without treatment, 1 for OP 10% CP; and 1 OP 40% HP. The unit of measure was Vickers hardness of each teeth, measured on the buccal surfaces.	56 teeth n=160 teeth • The total of patients was 40. Being 4 premolars analyzed for each patient. 2 teeth served as control group without treatment, 1 for OP 10% CP; and 1 OP 40% HP. The unit of measure was Vickers hardness of each teeth, measured on the buccal surfaces.
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: one month

Population: Two teeth serve as control.

Vickers hardness kg f/mm2 Baseline measurements: two nonbleached bicuspids in the dental arches. One first or second bicuspid in the maxillary arch was bleached with At-Home 10% Carbamide Peroxide and the contralateral bicuspid served as the control in the maxillary arch. One first or second bicuspid in the mandibular arch was bleached with In-Office 40% Hydrogen Peroxide and the other contralateral bicuspid in the mandibular arch served as the control. The control bicuspids served as the baseline measurements.

Outcome measures

Outcome measures
Measure	Control n=80 teeth Untreated Teeth	OP 10% CP n=40 teeth Teeth treated with 10% Carbamide Peroxide over a consecutive 14-day period.	OP 40% HP n=40 teeth Teeth treated with 40% Hydrogen Peroxide in a single session.
Enamel Hardness	348.4 Vickers hardness kg f/mm2 Interval 342.0 to 354.7	351.6 Vickers hardness kg f/mm2 Interval 341.9 to 361.2	354.5 Vickers hardness kg f/mm2 Interval 346.8 to 362.3

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OP 10% CP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OP 40% HP

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

Bruce A. Matis

Indiana University

Phone: 3172012089

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place