Trials Sponsors Conditions Drugs Pricing

Conditions

Dentin Desensitizers Dentin Hypersensitivity Non-carious Cervical Lesions

Keywords

Acmella oleraceaSpilantholDentin hypersensitivity

Outcome Measures

Primary Outcomes (1)

sensitivity assessment
Dentin hypersensitivity (DH) will be assessed at four time points: baseline (immediately before the first session), T1 (immediately before the second session), T2 (immediately before the third session), and T3 (one week after the final application of the products). DH will be evaluated using the Visual Analog Scale (VAS). This scale consists of a 10 cm horizontal line with scores of 0 and 10 at each end, where 0 indicates no sensitivity and 10 indicates severe dental sensitivity. Patients will be instructed to draw a vertical line along the horizontal scale to indicate the intensity of their dental sensitivity on the day of assessment.The distance from the zero end to the patient's mark will be measured using a millimeter ruler. These data will be recorded and tabulated for subsequent analysis.
30 days

Study Arms (4)

CT group: negative control group

PLACEBO COMPARATOR

the group will receive the application of gel without active ingredient

Other: CT- control group

NP Group - Potassium nitrate associated with 2% Fluoride

ACTIVE COMPARATOR

the group will receive the application of gel containing potassium nitrate

Other: NP- Potassium nitrate gel

Group AO - Acmella Oleracea extract gel

EXPERIMENTAL

the group will receive the application of gel containing Acmella Oleracea Extract Gel

Interventions

CT- control groupOther

will receive the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel.

CT group: negative control group

NP- Potassium nitrate gelOther

The gels will be applied to the sensitive lesions according to the experimental group and will be rubbed for 20 seconds using a microbrush, remaining on the lesions for 10 minutes.

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Presence of non-carious cervical lesions with sensitivity and up to 2 mm in depth
Miller Class I gingival recession

Sponsors & Collaborators

Universidade Federal do Para
Otherlead

Study Sites (1)

Universidade Federal Do Para

Belém, Pará, Brazil

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Fluorides

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsHydrofluoric AcidFluorine Compounds

Study Officials

Cecy M Silva
universidade federal do pará
PRINCIPAL INVESTIGATOR

Enrollment

100 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor of the Graduate Program in Dentistry at the Federal University of Pará

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 14, 2025

Study Start

August 20, 2024

Actual (reported)

Effect of an Experimental Gel Based on Acmella Oleracea Extract Associated or Not With Fluoride on Dentin Hypersensitivity

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

CT group: negative control group

NP Group - Potassium nitrate associated with 2% Fluoride

Group AO - Acmella Oleracea extract gel

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

AF Group - Acmella Oleracea extract gel associated with Fluoride.

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

CT group: negative control group

NP Group - Potassium nitrate associated with 2% Fluoride

Group AO - Acmella Oleracea extract gel

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

AF Group - Acmella Oleracea extract gel associated with Fluoride.

You may not qualify if:

Data Sharing

Source record

Locations