Pregabalin Gel in Reducing Post-operative Tooth Sensitivity Surgery Caused by Bleaching With 35% Hydrogen Peroxide

NCT06180707 | Unknown Phase 3 DMC

• 1 other identifier: UFParaPPGO
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Bleaching; Sensitivity, Tooth

Keywords

pregabalin; sensitivity dental; tooth whitening

Outcome Measures

Primary Outcomes (1)

• degree of tooth sensitivity after tooth whitening with hydrogen peroxide

  Experimental pregabalin gel reduces sensitivity related to tooth whitening with hydrogen peroxide 35%

  immediately after the intervention, and for a period of 21 days of treatment

Secondary Outcomes (1)

• change in color of teeth bleached with hydrogen peroxide

  one week after the last whitening session

Study Arms (3)

gel of pregabalin

EXPERIMENTAL

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).

Drug: pregabalin gel

gel with 5% potassium nitrate and 2% sodium fluoride

ACTIVE COMPARATOR

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).

Drug: gel with 5% potassium nitrate and 2% sodium fluoride

placebo gel (carbopol 1%)

PLACEBO COMPARATOR

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).

Other: Placebo gel

Interventions

pregabalin gel DRUG

10% pregabalin gel (carbopol-based gel to which the drug has been added) for topical application to teeth before bleaching with hydrogen peroxide

Also known as: GPG

gel of pregabalin

gel with 5% potassium nitrate and 2% sodium fluoride DRUG

gel of 5% potassium nitrate and 2% sodium fluoride for topical application to teeth before bleaching with hydrogen peroxide

Also known as: NKFG

gel with 5% potassium nitrate and 2% sodium fluoride

Placebo gel OTHER

placebo gel (carbopol-based gel 1%) for topical application to teeth before bleaching with hydrogen peroxide

Also known as: PG

placebo gel (carbopol 1%)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must have at least 28 teeth in the cavity
• good oral and general health

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Para: lead

Study Sites (1)

Federal University of Pará School of Dentistry

Belém, Pará, 66075-110, Brazil

Location

Related Publications (2)

• Parreiras SO, Szesz AL, Coppla FM, Martini EC, Farago PV, Loguercio AD, Reis A. Effect of an experimental desensitizing agent on reduction of bleaching-induced tooth sensitivity: A triple-blind randomized clinical trial. J Am Dent Assoc. 2018 Apr;149(4):281-290. doi: 10.1016/j.adaj.2017.10.025. Epub 2018 Feb 10.

  PMID: 29439773 BACKGROUND

• Xavier GMB, Paes YFO, de Meneses Costa Ferreira LM, Lamarao MLN, Silva CM, Ribeiro-Costa RM, Araujo JLN. Effect of an experimental pregabalin gel on dental sensitivity and color change after bleaching with 35% hydrogen peroxide: a randomized clinical trial. Clin Oral Investig. 2025 Mar 1;29(3):165. doi: 10.1007/s00784-025-06168-w.

  PMID: 40024965 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

guanylyl-(3'-5')-guanosine; Gels; potassium nitrate; Sodium Fluoride

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Jesuína L Nogueira Araújo, Doctor

  Federal University of Pará

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesuina L Nogueira Araujo, Doctor

CONTACT

5591991442849; jesuinalamartine@hotmail.com

Gabriela M Barbosa Xavier, Msc

CONTACT

91982472809; gabrielamontb@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal researcher

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 22, 2023
• Study Start: January 5, 2024
• Primary Completion: March 3, 2024
• Study Completion: April 30, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)