- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05725850
The Effect of an Experimental Gel Based on Acmella Oleracea Extract in Reducing Post-bleaching Tooth Sensitivity
February 10, 2023 updated by: Cecy Martins Silva, Universidade Federal do Para
Evaluation of the Effect of an Experimental Gel Based on Jambu Extract ( Acmella Oleracea) in Reducing Post-bleaching Tooth Sensitivity : a Randomized Clinical Study
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
PA
-
Belém, PA, Brazil, 66075-110
- Federal University of Para
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: EG (Experimental A. Oleracea extract gel)
The EG group received the application of experimental gel of A. Oleracea extract for post tooth bleaching sensitivity.
|
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.
|
PLACEBO_COMPARATOR: GP (Gel placebo)
The GP group received the application of a placebo gel.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of post bleaching sensitivity
Time Frame: 21 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Color evaluation
Time Frame: Baseline (Ti) and one week after the 3rd whitening session (Tf).
|
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 (ΔE00).
|
Baseline (Ti) and one week after the 3rd whitening session (Tf).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 7, 2022
Primary Completion (ACTUAL)
December 27, 2022
Study Completion (ACTUAL)
December 27, 2022
Study Registration Dates
First Submitted
February 2, 2023
First Submitted That Met QC Criteria
February 10, 2023
First Posted (ACTUAL)
February 13, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 13, 2023
Last Update Submitted That Met QC Criteria
February 10, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFPara-015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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