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

NCT07478640 | Completed Phase 3 DMC

• 1 other identifier: 7.589.000
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Sensitivity; Teeth Whitening

Keywords

Acmella oleracea; tooth sensitivity; teeth whitening; dentin desensitizers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in the color of teeth bleached with hydrogen peroxide.

  one week after the last whitening session.

Study Arms (3)

Bioadhesive film of Acmella Oleracea (jambu)

EXPERIMENTAL

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)

Gel containing 5% potassium nitrate and 2% sodium fluoride

ACTIVE COMPARATOR

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.

Spilanthol-free bioadhesive bioplastic film

PLACEBO COMPARATOR

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

Interventions

Bioadhesive film of Acmella Oleracea (jambu) DRUG

Bioadhesive film of Acmella Oleracea (jambu) for topical application as a tape on teeth prior to teeth whitening with hydrogen peroxide.

Bioadhesive film of Acmella Oleracea (jambu)

Gel containing 5% potassium nitrate and 2% sodium fluoride. DRUG

Gel containing 5% potassium nitrate and 2% sodium fluoride for topical application to teeth prior to bleaching with hydrogen peroxide.

Gel containing 5% potassium nitrate and 2% sodium fluoride

Spilanthol-free bioadhesive bioplastic film OTHER

Spilanthol-free bioadhesive bioplastic film for topical application as a tape on teeth prior to bleaching with hydrogen peroxide.

Spilanthol-free bioadhesive bioplastic film

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)

Faculdade de Odontologia da Universidade Federal do Pará

Belém, Pará, 66075-110, Brazil

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

potassium nitrate; Sodium Fluoride

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Jesuina L Nogueira Araujo, doutoura

  Universidade Federal do Pará

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 17, 2026
• Study Start: April 1, 2024
• Primary Completion: June 22, 2025
• Study Completion: March 2, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)