The Effect of an Experimental Gel Based on Acmella Oleracea Extract in Reducing Post-bleaching Tooth Sensitivity

Pain Clinical Trial

Official title:

Evaluation of the Effect of an Experimental Gel Based on Jambu Extract ( Acmella Oleracea) in Reducing Post-bleaching Tooth Sensitivity : a Randomized Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05725850
• Other study ID #: UFPara-015
• Status: Completed
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: December 27, 2022

Study information

• Verified date: February 2023
• Source: Universidade Federal do Para
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind clinical trial aimed to evaluate the effect of an experimental gel containing 10% jambu extract (Acmella Oleracea) in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. The volunteers of this study were randomized into two different groups - GE (A. Oleracea extract at 10%) and GP (placebo). The dental elements of the GE received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes. The GP group also received the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel. Subsequently, all groups underwent in-office bleaching treatment with 35% hydrogen peroxide.Post-bleaching sensitivity was collected through a form composed of the visual analogue scale (VAS). Color measurement was performed at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 27, 2022
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• good oral hygiene
• absence of active caries lesions
• never having undergone previous whitening therapy
• not present dental hypersensitivity
• don't be a smoker
• not be pregnant
• present at least 28 teeth in the oral cavity.

Exclusion Criteria:

• volunteers who were under orthodontic treatment,
• presence of periodontal disease
• dental cracks or fractures
• restorations and prostheses on anterior teeth
• extensive molar restorations
• gastroesophageal disorders
• severe internal dental darkening
• presence of dentinal exposure in anterior and / or posterior teeth.

Related Conditions & MeSH terms

• Dentin Desensitizing Agents
• Dentin Sensitivity
• Pain
• Tooth Bleaching

Intervention

Other:
• EG (Experimental A. Oleracea extract gel)
Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the EG received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes.
• GP (Gel placebo)
Prior to bleaching treatment with 35% hydrogen peroxide, the GP group also received the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel.

Locations

Country	Name	City	State
Brazil	Federal University of Para	Belém	PA

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Para

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of post bleaching sensitivity	For the assessment of postoperative sensitivity, patients were instructed to fill out a form to record tooth sensitivity daily, during the 21 days of treatment, based on individual pain perception. This form was delivered at each bleaching session, being returned to the researcher in the following session, that is, always one week after each bleaching session. The evaluation form consisted of the visual analogue scale (VAS). This scale consists of a 10 cm horizontal line, with scores of 0 and 10 at its ends, where 0 means no sensitivity and 10 means severe tooth sensitivity. The patient was instructed to draw a vertical line along the horizontal line of the scale, recording the intensity of tooth sensitivity per day. So that the distance in millimeters from the zero end could be later measured with the aid of a millimeter ruler, thus obtaining the patient's level of pain intensity.	21 days
Secondary	Color evaluation	The VITA Easyshade spectrophotometer (VITA Zahnfabrik, Bad Säckingen, Germany) was used to measure the color, where the area of dental correspondence to be evaluated was the middle third of the buccal surface of the upper canines. To standardize the color readings, silicone trays were made, where the impression was extended from canine to canine. A window was created on the buccal surface of each canine of the silicone guide using a metal device with a 6 mm radius, corresponding to the diameter of the spectrophotometer tip. Thus, the tip of the device was inserted into the silicone guide to obtain the color parameters. Subsequently, the color difference between baseline (T i ) and one week after the 3rd bleaching session (T f ) was calculated using the CIEDE2000 formulas (?E00).	Baseline (Ti) and one week after the 3rd whitening session (Tf).