Assessment of Effect of an Experimental Pregabalin Gel in Reducing Post-operative Tooth Sensitivity Surgery Caused by Bleaching With 35% Hydrogen Peroxide
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Universidade Federal do Para
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- degree of tooth sensitivity after tooth whitening with hydrogen peroxide
Study Overview
Brief Summary
Even with a large number of agents with action desensitizing agents (which reduce the symptoms of tooth sensitivity) available in market, there is no treatment considered the gold standard, which is completely effective for treat sensitivity caused by tooth whitening treatment. In this sense, the Pregabalin (PG), a medication with analgesic and anti-inflammatory action, can be a effective alternative to control this discomfort.
Therefore, the objective of this project is to evaluate the effect of applying a gel containing the 10% Pregabalin associated with in-office teeth whitening, in reducing sensitivity dental.
Detailed Description
Obtaining experimental pregabalin gel Pregabalin gel (PG) was obtained using a 1% carbopol gel base (carbopol 940, methylparaben, propylparaben, Ethylenediamine tetraacetic acid (EDTA), propylene glycol, 50% triethanolamine and distilled water) to which a solution of 10mg/ml of pregabalin. Obtaining a transparent, clear and consistent gel.
This pharmaceutical form was obtained from the Pharmaceutical Nanotechnology Laboratory of the Federal University of Pará and underwent characterization studies (FTIR, thermal analyses), study of rheological and stability properties (preliminary and accelerated), in addition to cytotoxicity assessment. Furthermore, a previous study for in vitro evaluation of the pregabalin gel associated with tooth whitening on dental enamel has also been carried out. It is noteworthy that satisfactory results were obtained, which make it safe for clinical application.
Sample calculation To define the sample size, a pilot study will be carried out (statistical power of 80% and an error probability α of 5%).
Sample selection Participants aged 18 to 40 of both sexes, with good oral health, will be selected. Individuals with active caries or periodontal disease, visible cracks in upper or lower anterior teeth, with evident malocclusion, restorations and prosthetics in anterior teeth, gastroesophageal disorders, severe internal discoloration of the tooth (tetracycline, fluorosis or pulped teeth) are excluded. dentine exposure in anterior and/or posterior teeth, parafunctional habits, tooth sensitivity, whitening treatment prior to or undergoing orthodontic treatment. Furthermore, smokers, pregnant or breastfeeding women will not be included. Finally, participants must have at least 28 teeth in the oral cavity.
All participants will undergo prophylaxis carried out with a rubber cup and pumice stone seven days before the start of the clinical trial and will receive hygiene kits, with a toothpaste without desensitizing action and without fluoride, in order to mitigate possible interference in the evaluation of the results. The kit will consist of a toothbrush (Oral B, Ropes Indicator, São Paulo (SP), Brazil) and a toothpaste (My First Colgate®, Colgate Company, Sao Paulo, Brazil), with instructions for use three times a day.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants must have at least 28 teeth in the cavity
- •good oral and general health
Exclusion Criteria
- •active caries or periodontal disease
- •visible cracks in front teeth upper or lower
- •with evident malocclusion
- •restorations and prosthetics in teeth anterior teeth
- •gastroesophageal disorders
- •severe internal tooth discoloration (tetracycline , fluorosis or pulped teeth)
- •dentin exposure in anterior teeth and /or later
- •parafunctional habits
- •tooth sensitivity
- •whitening treatment prior to or undergoing orthodontic treatment
- •Furthermore, smokers, pregnant or breastfeeding women do not will be included.
Arms & Interventions
gel of pregabalin
The experimental 10% pregabalin gel (GPG) will be applied to the buccal surfaces of the central and lateral incisors, canines and upper and lower premolars, with an active microbrush, for 10 minutes. Subsequently, all groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be carried out using a form consisting of a visual analogue scale (VAS), patients will be instructed to record tooth sensitivity daily, during the 21 days of follow-up. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf).
Intervention: pregabalin gel (Drug)
gel with 5% potassium nitrate and 2% sodium fluoride
The gel with 5% potassium nitrate and 2% sodium fluoride (NKFG) will be applied to the buccal surfaces of the central and lateral incisors, canines and upper and lower premolars, with a microbrush actively, for 10 minutes. Subsequently, all groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be carried out using a form consisting of a visual analogue scale (VAS), patients will be instructed to record tooth sensitivity daily, during the 21 days of follow-up. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf).
Intervention: gel with 5% potassium nitrate and 2% sodium fluoride (Drug)
placebo gel (carbopol 1%)
The placebo gel (PG) will be applied to the buccal surfaces of the central and lateral incisors, canines and upper and lower premolars, with a microbrush actively, for 10 minutes. Subsequently, all groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be carried out using a form consisting of a visual analogue scale (VAS), patients will be instructed to record tooth sensitivity daily, during the 21 days of follow-up. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany)) will be used at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf).
Intervention: Placebo gel (Other)
Outcomes
Primary Outcomes
degree of tooth sensitivity after tooth whitening with hydrogen peroxide
Time Frame: immediately after the intervention, and for a period of 21 days of treatment
Experimental pregabalin gel reduces sensitivity related to tooth whitening with hydrogen peroxide 35%
Secondary Outcomes
- change in color of teeth bleached with hydrogen peroxide(one week after the last whitening session)
Investigators
Jesuína Lamartine Nogueira Araújo
principal researcher
Universidade Federal do Para