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

NCT07173296 | Recruiting

• 1 other identifier: 0541-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Sensitivity

Keywords

Sensitivity; Application mode; in-office bleaching

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (1)

• Change in teeth color

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

Study Arms (2)

Opalescence

EXPERIMENTAL

Group 1: Opalescence XTra Boost 40% HP (OB) \[Ultradent, Salt Lake, UT, USA\] which will be used in a split-mouth design for a single application for 40 minutes and 2 applications for 20 minutes each.

Other: Opalescence XTra Boost 40% HP

PolaOffice

EXPERIMENTAL

Group 2: Pola Office Plus 37.5% HP (PO) \[SDI, Bayswater, Australia\] which will be applied in a split-mouth design for a single 32 minutes and 4 applications of 8 min each

Other: Pola Office Plus 37.5% HP

Interventions

Opalescence XTra Boost 40% HP OTHER

In-office tooth bleaching material

Opalescence

Pola Office Plus 37.5% HP OTHER

In-office tooth bleaching material

PolaOffice

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• No restorations or carious lesions on the buccal surfaces of the anterior teeth to be whitened
• No history of tooth sensitivity
• No use of a desensitizing agent or desensitizing toothpaste in the past six months
• No use of pain killer for the last 48 hours

You may not qualify if:

• Active caries and/or periodontal diseases (gingivitis and recession) or wasting diseases
• Smokers
• Pregnant/lactating women.
• Patients who have bleached their teeth previously.
• No schedule availability

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan University of Science and Technology

Irbid, Jordan

RECRUITING

MeSH Terms

Conditions

Dentin Sensitivity; Hypersensitivity

Interventions

pola office

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Study Officials

• Ghada A Maghaireh

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghada A Maghaireh

CONTACT

0798809296; gmaghair@just.edu.jo

Ghada Maghaireh

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will be a randomized, single-blind (evaluators), split-mouth with an equal allocation rate between groups. Blocked randomization will be performed (block size of 2) to guarantee equal-sized groups with an equal allocation ratio at www.sealedenvelope.com. A third party not involved in the study will prepare consecutively numbered, opaque, and sealed envelopes containing information identifying the groups. The group that will be identified in the envelope will be corresponded to the treatment that will be performed on the right upper hemiarch, and the left hemiarch will receive the alternate treatment.

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 15, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)