Evaluation of Tooth Sensitivity Related to in Office Bleaching in a Randomized Clinical Trial: Effect of Potassium Oxalate and Placebo
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Risk to the tooth sensitivity (VRS)
Study Overview
Brief Summary
Purpose: This study will determine the effectiveness of the use of desensitivity gels prior in office bleaching on risk and intensity of tooth sensitivity caused by in-office bleaching using 35% hydrogen peroxide. Materials and Methods: Fifty patients will be selected for this triple-blind, randomized, cross-over, placebo-controlled clinical trial. 10 minutes prior to bleaching procedure, patients will receive the potassium oxalate 5% desensitivity gel and placebo application on vestibular surface. The whitening treatment with 35% hydrogen peroxide will be carried out in two sessions with a 7-day interval. Tooth sensitivity will be assessed before, during and 24 hours after the procedure using analog visual and verbal scales. Color alteration will be assessed by a Classical guide scale. Relative risk to sensitivity will be calculated and adjusted by session; while comparison of overall risk will performed by McNemar's test. Data on the sensitivity level for both scales and color shade will be subjected to the Friedman, Wilcoxon and Mann-Whitney tests, respectively (α = 0.05)
Detailed Description
Methods & Materials:
This clinical trial was approved by the Scientific Review Committee and by the Committee for the Protection of Human Subjects of the local University (CAAE 60259916.0.0000.5546).
Trial design:
This study will be a randomized, triple-blinded, placebo-controlled clinical trial, and split mouth study design.
The patients included will be submitted to two in-office bleaching sessions receiving the potassium oxalate 5% desensitivity and placebo gel application on vestibular surface, for 10 minutes. A delay of 1 week between the sessions will be established. The study will be conducted at the clinic of the School of Dentistry of the local university from February 2017 to June 2018.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients included in this clinical trial will be at least 18 years old with good oral health;
- •Patients presenting all six upper anterior teeth with shade mismatching with 2.5 M2 (Vita - Bleachguide 3D-Master scale, Vita-Zahnfabrik, Bad Sackingen, Germany) or darker will be included.
Exclusion Criteria
- •Patients with any of the six upper anterior teeth with caries;
- •Restorations in anterior teeth'
- •Patients with tooth severe discoloration (e.g., stains caused by tetracycline);
- •Presence of enamel hypoplasia;
- •Presence of gingival recession or dentin exposure;
- •Presence of tooth pulpitis or endodontics;
- •Participants submitted to previous bleaching procedures;
- •Patients with prior tooth sensitivity;
- •Patients with known allergy to any component of medication used in the study;
- •Pregnant or breastfeeding will also be also excluded.
Arms & Interventions
Potassium Oxalate 5% gel
The patient will receive the application of potassium oxalate 5% gel on vestibular surface teeth, for 10 minutes.
Intervention: Potassium oxalate 5% gel (Procedure)
Placebo gel
The patient will receive the application placebo gel on vestibular surface teeth, for 10 minutes.
Intervention: Placebo gel (Procedure)
Outcomes
Primary Outcomes
Risk to the tooth sensitivity (VRS)
Time Frame: During the bleaching treatment.
The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe. Score different from 0 will determine presence of sensitivity. The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.
Risk to the tooth sensitivity (VAS)
Time Frame: During the bleaching treatment.
The tooth sensitivity will be assessed using a Visual analogue (VAS) and verbal scales. VAS consisted of a 10-cm scale 0 (no sensitivity) 10 (unbearable sensitivity). A slightly air-stream will be applied over the buccal surfaces of the central incisors, and the patients will record their sensitivity perception by pointing with a pen on the scale. The distance between the marking and the border of scale, relative to the absence of sensitivity will be measured. The measurements will be scored according to the distance from 0, using a digital caliper. The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated
Secondary Outcomes
- Risk after tooth sensitivity- after the procedure (VRS)(24 hours after the Bleaching procedure)
- Level of tooth sensitivity (VAS)(During the Bleaching procedure)
- Level of tooth sensitivity - after the procedure (VAS)(24 hours after the Bleaching procedure)
- Level of tooth sensitivity - after the procedure (VRS)(24 hours after the Bleaching procedure)
- Level of tooth sensitivity (VRS)(During the Bleaching procedure)
- Risk after tooth sensitivity- after the procedure (VAS)(24 hours after the Bleaching procedure)
- Bleaching Effectiveness (shade guide scale)(Before the bleaching procedures and 7 days after this)
Investigators
Flavia Pardo Salata Nahsan
Principal Investigator
Universidade Federal de Sergipe