Effect of Pregabalin Gel in Controlling Cervical Dentin Hypersensitivity

NCT06417580 | Not Yet Recruiting Phase 2

• 1 other identifier: ppgoufpa
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized, double-blind, placebo-controlled clinical study aims to evaluate the effect of a gel formulation based on 10% of pregabalin in the treatment of HD and on the participants' quality of life. The sample calculation will be based on previous work. After selecting participants, the participants will be randomly assigned to the following groups: placebo control group (CG), potassium nitrate gel group (GNK) and pregabalin gel group (GPG). A questionnaire (QEDH-15) to assess the impact of desensitizing treatment on oral health-related quality of life (OHRQoL) will be applied at baseline (T0) and in the last sensitivity record (T6). Pain will be assessed using a visual analogue scale after evaporative stimulation with an air jet and tactile stimulation with an exploratory probe. Three desensitizing treatment sessions will be carried out, with an interval of 72 hours between them. Sensitivity recording will be performed at T0 (baseline), T1 (after the first session), T2 (after the second session), T3 (after the third session), T4 (7 days after the last session), T5 (one month after the last session) and T6 (3 months after the last session). Data will be collected and subjected to statistical analysis for parametric data (ANOVA followed by Student-Newman-Keuls) or non-parametric data (Friedman's ANOVA followed by Tukey). To analyze the impact on quality of life, the Friedman test will be used.

Conditions

Dentin Sensitivity

Keywords

pregabalin; dental sensitivity

Outcome Measures

Primary Outcomes (1)

• Number of Participants with dentin hypersensitivity: an average of 6 participants and 21 sensitive teeth in the group.

  The use of 10% pregabalin gel influence in the painful symptoms of dentin hypersensitivity. The results will be evaluated through study completion, an average of 3 months for each participant. The data will tell if the positive results were of short, medium and long-term.

  Through study completion, an average of 3 months for each participant

Study Arms (3)

Negative Control Group

PLACEBO COMPARATOR

A negative control group with gel without any active ingredient. The protocol used for all groups will be the same: prophylaxis with an extra soft robinson brush and pumice stone, insertion of retractor thread number #000 in the gingival sulcus and then application and friction of the placebo gel with a microbrush applicator for 10 seconds, which will remain in contact with the tooth surface for 10 minutes, and the excess will be subsequently removed. Three desensitizing treatment sessions will be carried out, with an interval of 72 hours between each session.

Other: Placebo Treatment

Positive Control Group

ACTIVE COMPARATOR

Potassium nitrate gel group that will serve as a positive control The protocol used for all groups will be the same: prophylaxis with an extra soft robinson brush and pumice stone, insertion of retractor thread number #000 in the gingival sulcus and then application and friction of the potassium nitrate gel with a microbrush applicator for 10 seconds, which will remain in contact with the tooth surface for 10 minutes, and the excess will be subsequently removed. Three desensitizing treatment sessions will be carried out, with an interval of 72 hours between each session.

Other: Nitrate Potassium Treatment

Experimental group

EXPERIMENTAL

Experimental group with 10% pregabalin gel. The protocol used for all groups will be the same: prophylaxis with an extra soft robinson brush and pumice stone, insertion of retractor thread number #000 in the gingival sulcus and then application and friction of the pregabalin gel with a microbrush applicator for 10 seconds, which will remain in contact with the tooth surface for 10 minutes, and the excess will be subsequently removed. Three desensitizing treatment sessions will be carried out, with an interval of 72 hours between each session.

Other: Pregabalin Treatment

Interventions

Placebo Treatment OTHER

Desensitizing protocol with none active ingredient to evaluate the control of cervical dentin hypersensitivity

Negative Control Group

Nitrate Potassium Treatment OTHER

Desensitizing protocol with potassium nitrate gel to analyze and compare with other groups the effects of controlling cervical dentin hypersensitivity

Positive Control Group

Pregabalin Treatment OTHER

Desensitizing protocol with experimental 10% pregabalin gel to evaluate the control of cervical dentin hypersensitivity

Experimental group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sensitive teeth with a response ≥ 04 on the visual analog scale (VAS) to tactile and evaporative stimuli;
• Dentin exposure in anterior and/or posterior teeth, either due to the presence of non-carious cervical lesions and/or gingival recession.

You may not qualify if:

• Allergic to the active ingredient and/or components of the formulation;
• Carious lesions and/or dental pulpitis;
• Recent medication with analgesics or anti-inflammatories;
• Received desensitizing treatment, orthodontic treatment, or having undergone tooth whitening up to six months prior baseline.
• Large restorations in sensitive teeth
• Eating disorders (bulimia, anorexia,...)
• Periodontal disease (moderate to severe)
• Bruxism
• Cracks or fractures in the enamel;
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Jesuína Lamartine Nogueira Araújo: lead

Related Publications (5)

• World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

  PMID: 24141714 BACKGROUND

• Barros APO, de Melo Alencar C, de Melo Pingarilho Carneiro A, da Silva Pompeu D, Barbosa GM, Araujo JLN, Silva CM. Combination of two desensitizing protocols to control dentin hypersensitivity in non-carious lesions: a randomized, double-blind clinical trial. Clin Oral Investig. 2022 Feb;26(2):1299-1307. doi: 10.1007/s00784-021-04104-2. Epub 2021 Aug 5.

  PMID: 34351504 BACKGROUND

• Douglas-De-Oliveira DW, Lages FS, Paiva SM, Cromley JG, Robinson PG, Cota LOM. Cross-cultural adaptation of the Brazilian version of the Dentine Hypersensitivity Experience Questionnaire (DHEQ-15). Braz Oral Res. 2018;32:e37. doi: 10.1590/1807-3107bor-2018.vol32.0037. Epub 2018 May 3.

  PMID: 29723336 BACKGROUND

• Tolentino AB, Zeola LF, Fernandes MRU, Pannuti CM, Soares PV, Aranha ACC. Photobiomodulation therapy and 3% potassium nitrate gel as treatment of cervical dentin hypersensitivity: a randomized clinical trial. Clin Oral Investig. 2022 Dec;26(12):6985-6993. doi: 10.1007/s00784-022-04652-1. Epub 2022 Jul 25.

  PMID: 35871702 BACKGROUND

• Sgreccia PC, Dame-Teixeira N, Barbosa RES, Araujo PF, Zanatta RF, Garcia FCP. Assessment of the Oral Health Impact Profile (OHIP-14) improvement of different treatments for dentin hypersensitivity in noncarious cervical lesions-a randomized clinical study. Clin Oral Investig. 2022 Nov;26(11):6583-6591. doi: 10.1007/s00784-022-04610-x. Epub 2022 Jul 7.

  PMID: 35796800 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Jesuina L Nogueira Araujo, Doctor

  Federal University of Pará

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesuina L. N. Araujo, Doctor

CONTACT

5591991442849; jesuinalamartine@hotmail.com

Yngrid F. O. Paes, Bachelor

CONTACT

5591987059299; yngrid.paes@ics.ufpa.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This double-blind study guarantees the confidentiality of the interventions, since both the research participant and the main researcher will not be able to differentiate the procedure applied. The placebo gel, the experimental desensitizing gel and the potassium nitrate gel will be inserted into a dappen jar delivered immediately before the clinical interventions by a research collaborator. The gels have a similar texture, color and odor to prevent identification. The evaluator will also not be aware of the group the participant belonged to, as they will not participate in the randomization process. The research will have a single operator to carry out the clinical part.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinator and professor of the Postgraduate Program in Dentistry at Universidade Federal do Pará

Model Details: This randomized clinical trial will be parallel, double-blind, placebo-controlled. Composed of three groups: a placebo control group with gel without any active ingredient (CG), a group with potassium nitrate gel (GNK) and an experimental group with 10% potassium pregabalin gel (GPG). Applications will be carried out in 3 sessions with an interval of 72 hours between each one. Sensitivity recording will be performed at T0 (baseline), T1 (after first session), T2 (after second session), T3 (after third session), T4 (7 days after the last session) and T5 (one month after the last session) and T6 (3 months after the last session). A questionnaire (QEDH-15) will be applied to evaluate the impact of desensitizing treatment on improving the participants' oral health-related quality of life (HRQoL). The questionnaire will be applied at baseline (T0) and at the last sensitivity record (T6).

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: May 16, 2024
• Study Start: May 28, 2024
• Primary Completion: September 28, 2024
• Study Completion: September 28, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share