The Effect of Bleaching Application Mode on Bleaching-induced Tooth Sensitivity.

ConditionTooth Sensitivity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-35

SponsorKing Abdullah University Hospital

About this trial

The aim of this study is to evaluate the effect of single versus multiple application protocols for in-office dental bleaching using two different bleaching gels (Pola Office Plus, SDI, 37.5% HP and Opalescence Boost, Ultradent, 40% HP) on the risk and intensity of tooth sensitivity, as well as the effect of the application protocol on the bleaching efficacy.

Null hypothesis: There is no difference in intensity and risk of tooth sensitivity between single and multiple application of each gel and the application protocol dose not present significant effect on the bleaching efficacy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

At least eight maxillary anterior teeth present.

Age over 18

The selected teeth have a mean shade of C2 or darker.

Good general and oral health. (no visible plaque or gingivitis)

Disqualifiers

Active caries and/or periodontal diseases (gingivitis and recession) or wasting diseases

Smokers

Pregnant/lactating women.

Patients who have bleached their teeth previously.

Trial design

Design model

Parallel

Treatments tested in this trial

Opalescence XTra Boost 40% HP
Other intervention
In-office tooth bleaching material
Pola Office Plus 37.5% HP
Other intervention
In-office tooth bleaching material

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: OpalescenceExperimental treatment 1 intervention

Group B: PolaOfficeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Tooth Sensitivity

Assessing reported tooth sensitivity by two scales.The VAS is a horizontal line with ten digits on it, ranging from 0 to 10, where 0 denotes no pain and 10 represents the worst possible suffering. The participants will be asked to identify their level of pain by marking the corresponding number. The NRS scale comprises scores to denote the intensity of pain (0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = intense).

Time frame

Assess sensitivity during the bleaching, 1 hour after bleaching, 1 day, 2 days and 7 days after bleaching.

Secondary outcomes

Change in teeth color

Assessing the change in tooth color by two ways. Subjectively using the VITA classical shade guide and Vita Bleached guide and objectively using the VITA easy shade spectrophotometer.

Time frame

Shade will be recorded at base line before the bleaching procedure, seven days later, and 30 days after the end of the bleaching treatment.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King Abdullah University Hospital

Lead sponsor

Jordan University of Science and Technology

Collaborator

Source ClinicalTrials.gov

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