MedDataX Logo

Three Anxiolytic Drugs Used in Third Molar Surgery

NCT ID: NCT02065843

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was to compare the effectiveness of three drugs (Passiflora incarnata, Erythrina mulungum, Midazolam) in controlling anxiety in patients undergoing bilateral extraction of asymptomatic, impacted mandibular third molars.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this research, characterized as a randomized, double-blind, parallel study, 200 healthy volunteered patients aging 18 or older will be distributed into 4 groups (n=50) as follows: Group I - 500mg Erythrina mulungu; Group II - placebo; Group III ; 100 mg Passiflora incarnata; Group IV - 15 mg midazolam. All treatments will be administered p.o. 1 hour randomly prior to the surgical procedures. The level of anxiety will be assessed through questionnaires and physical parameters, such as blood pressure, heart rate and oxygen concentration in three periods: at baseline, right before the surgical procedures and after 7 days. Data will be collected, tabulated and analyzed by the following statistical tests: chi-square, t-test, ANOVA and Tukey test, Friedman, Fisher's exact test with significance level of 5%.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Anxiety Impacted Third Molar Tooth

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Anxiety Third molar surgery Blood pressure Heart rate Oxygen saturation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mulungu

500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure.

Group Type ACTIVE_COMPARATOR

Mulungu

Intervention Type DRUG

500 mg/single dose/1 hour before dental surgery

placebo

500 mg of starch (2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

500 mg/single dose/1 hour before dental surgery

Passiflora incarnata

100 mg Passiflora incarnata (2 capsules of 50 mg) to be administered v.o., one hour before the surgical procedure.

Group Type ACTIVE_COMPARATOR

Passiflora incarnata

Intervention Type DRUG

100 mg/single dose/1 hour before dental surgery

midazolam

15 mg midazolam (2 capsules of 7.5 mg) to be administered v.o., one hour before the surgical procedure.

Group Type ACTIVE_COMPARATOR

midazolam

Intervention Type DRUG

15 mg/single dose/1 hour before dental surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mulungu

500 mg/single dose/1 hour before dental surgery

Intervention Type DRUG

Placebo

500 mg/single dose/1 hour before dental surgery

Intervention Type DRUG

Passiflora incarnata

100 mg/single dose/1 hour before dental surgery

Intervention Type DRUG

midazolam

15 mg/single dose/1 hour before dental surgery

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mulungu Matusa, Erytrina mulungu Dormonid

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* indication of bilateral extraction of asymptomatic, impacted mandibular third molars

Exclusion Criteria

* patients under the age of 18 any general health problem based on the medical history and physical examination history of use of any medication within 15 days before the beginning of the research history of hypersensitivity to drugs, substances or materials used in this experiment pregnancy or lactation history of pericoronitis
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Campinas, Brazil

OTHER

Sponsor Role collaborator

Universidade Federal de Sergipe

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Liane Maciel de Almeida Souza

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Liane M Souza, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Sergipe

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Federal University of Sergipe

Aracaju, Sergipe, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

Balbani AP, Silva DH, Montovani JC. Patents of drugs extracted from Brazilian medicinal plants. Expert Opin Ther Pat. 2009 Apr;19(4):461-73. doi: 10.1517/13543770902824180.

Reference Type BACKGROUND
PMID: 19441926 (View on PubMed)

Flausino OA Jr, Pereira AM, da Silva Bolzani V, Nunes-de-Souza RL. Effects of erythrinian alkaloids isolated from Erythrina mulungu (Papilionaceae) in mice submitted to animal models of anxiety. Biol Pharm Bull. 2007 Feb;30(2):375-8. doi: 10.1248/bpb.30.375.

Reference Type BACKGROUND
PMID: 17268084 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4192578/pdf/medoral-19-e518.pdf

published article

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ANSI-388.427

Identifier Type: -

Identifier Source: org_study_id