Bioadhesive Film of Acmella Oleracea (Jambu) in the Reduction of Post-bleaching Dental Sensitivity Caused by Bleaching With 35% Hydrogen Peroxide.

Application of Acmella Oleracea (Jambu) Bioadhesive Film in Reducing Tooth Sensitivity Induced by Dental Bleaching: a Randomized Clinical Trial.

Despite the wide range of desensitizing agents available on the market, there is still no gold standard treatment that is fully effective in managing sensitivity by dental bleaching. In this context, a bioadhesive film containing Acmella oleracea (jambu)-a natural product with anti-inflammatory and, most notably, analgesic properties-may represent an effective alternative for controlling this discomfort. Therefore, this project aims to clinically evaluate the efficacy of an Acmella oleracea extract bioadhesive film on tooth sensitivity induced by 35% hydrogen peroxide bleaching.

Study Overview

• Status: Completed
• Conditions: Tooth Sensitivity; Teeth Whitening
• Intervention / Treatment: Drug: Bioadhesive film of Acmella Oleracea (jambu); Drug: Gel containing 5% potassium nitrate and 2% sodium fluoride.; Other: Spilanthol-free bioadhesive bioplastic film

Detailed Description

Dental bleaching with hydrogen peroxide (HP) is a frequent treatment in dentistry, but it can present some adverse effects such as alterations in the surface structure of the teeth and tooth sensitivity. This study aimed to evaluate an experimental bioadhesive film of Acmella oleracea (jambu) extract on tooth sensitivity caused by bleaching with 35% hydrogen peroxide and its impact on the participants' oral health-related quality of life (OHRQoL). Seventy-two volunteers were divided into three different groups: GCP - Control group with bioadhesive bioplastic film without spilanthol, GKF - Desensitizing treatment group with 5% potassium nitrate and 2% sodium fluoride (Desensitize KF 2%), and GAO - Group with the experimental bioadhesive film of Acmella oleracea extract. In each group, the corresponding product was applied to the vestibular surfaces of the visible teeth for 10 minutes. Subsequently, all groups underwent an in-office dental bleaching protocol with 35% hydrogen peroxide. Tooth sensitivity was measured using the visual analog scale (VAS), the impact on oral health-related quality of life (OHRQoL) was assessed using the QEDH-15 questionnaire at baseline and at the last sensitivity record, and color measurement was performed at two time points: at baseline and one week after the 3rd bleaching session. Data were subjected to the Shapiro-Wilk normality test. For normally distributed variables, we used repeated measures ANOVA for intragroup analysis and one-way ANOVA for intergroup comparisons, with post-hoc tests when applicable. For non-parametric data, Friedman (intragroup) and Kruskal-Wallis (intergroup) tests were used. Color analysis (ΔE), considering the difference between initial and final times, and the impact on oral health-related quality of life followed the same statistical criteria, according to the data distribution. The significance level adopted was 5% for all analyses. The bioadhesive film is expected to have an effect on nociception and reduce sensitivity caused by bleaching.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Pará
    • Belém, Pará, Brazil, 66075-110
      • Faculdade de Odontologia da Universidade Federal do Pará

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bioadhesive film of Acmella Oleracea (jambu); The bioadhesive film of Acmella Oleracea (jambu) will be applied to the vestibular surfaces of the upper and lower central and lateral incisors, canines, and premolars, like a tape, for 10 minutes. Subsequently, all groups will undergo in-office dental whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be performed using a form composed of a visual analog scale (VAS). Patients will be instructed to record tooth sensitivity daily during the 21-day follow-up period. For color measurement, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two time points: at baseline (Ti) and one week after the 3rd whitening session (Tf).	Drug: Bioadhesive film of Acmella Oleracea (jambu); Bioadhesive film of Acmella Oleracea (jambu) for topical application as a tape on teeth prior to teeth whitening with hydrogen peroxide.
Active Comparator: Gel containing 5% potassium nitrate and 2% sodium fluoride; A gel containing 5% potassium nitrate and 2% sodium fluoride (NKFG) will be applied to the buccal surfaces of the upper and lower central and lateral incisors, canines, and premolars using an active microbrush for 10 minutes. Subsequently, all groups will undergo in-office dental whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity will be assessed using a visual analog scale (VAS) form. Patients will be instructed to record tooth sensitivity daily during the 21-day follow-up period. For color measurement, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two time points: at baseline (Ti) and one week after the 3rd whitening session (Tf).	Drug: Gel containing 5% potassium nitrate and 2% sodium fluoride.; Gel containing 5% potassium nitrate and 2% sodium fluoride for topical application to teeth prior to bleaching with hydrogen peroxide.
Placebo Comparator: Spilanthol-free bioadhesive bioplastic film; A spilanthol-free bioadhesive film made of bioplastic will be applied to the buccal surfaces of the upper and lower central and lateral incisors, canines, and premolars, as a tape, actively for 10 minutes. Subsequently, all groups will undergo in-office dental whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity will be assessed using a form consisting of a visual analog scale (VAS). Patients will be instructed to record tooth sensitivity daily during the 21-day follow-up period. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two time points: at baseline (Ti) and one week after the 3rd whitening session (Tf).	Other: Spilanthol-free bioadhesive bioplastic film; Spilanthol-free bioadhesive bioplastic film for topical application as a tape on teeth prior to bleaching with hydrogen peroxide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of tooth sensitivity after teeth whitening with hydrogen peroxide.	The bioadhesive film of Acemella Oleracea (jambu) reduces sensitivity related to teeth whitening with 35% hydrogen peroxide.	immediately after the procedure and during a 21-day treatment period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the color of teeth bleached with hydrogen peroxide.	Changes in the color of teeth bleached with hydrogen peroxide, even with the application of Acmella Oleracea (jambu) bioadhesive film.	one week after the last whitening session.

Collaborators and Investigators

• Sponsor: Universidade Federal do Para
• Investigators: Principal Investigator: Jesuina L Nogueira Araujo, doutoura, Universidade Federal do Para

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): June 22, 2025
• Study Completion (Actual): March 2, 2026

Study Registration Dates

• First Submitted: February 28, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: tooth sensitivity; Acmella oleracea; teeth whitening; dentin desensitizers
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dentin Sensitivity; Cariostatic Agents; Inorganic Chemicals; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Sodium Compounds; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Sodium Fluoride; potassium nitrate
• Other Study ID Numbers: 7.589.000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No