Three Anxiolytic Drugs Used in Third Molar Surgery

NCT02065843 | Completed Phase 2

• 1 other identifier: ANSI-388.427
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Anxiety; Impacted Third Molar Tooth

Keywords

Anxiety; Third molar surgery; Blood pressure; Heart rate; Oxygen saturation

Outcome Measures

Primary Outcomes (1)

• Changes in anxiety report

  Changes in the subjects' anxiety level will be observed by using a Modified Corah Dental Anxiety Scale in three times: at baseline, in the day of surgery and after 7 days of the procedure.

  Change from baseline to 7 days

Secondary Outcomes (3)

• Changes in blood pressure

  Change from baseline to 2 hours

• Changes in heart rate

  Change from baseline to 2 hours

• Changes in oxygen saturation

  Change from baseline to 2 hours

Study Arms (4)

Mulungu

ACTIVE COMPARATOR

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

Drug: Mulungu

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Passiflora incarnata

ACTIVE COMPARATOR

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

Drug: Passiflora incarnata

midazolam

ACTIVE COMPARATOR

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

Drug: midazolam

Interventions

Mulungu DRUG

500 mg/single dose/1 hour before dental surgery

Also known as: Mulungu Matusa, Erytrina mulungu

Mulungu

Placebo DRUG

500 mg/single dose/1 hour before dental surgery

placebo

Passiflora incarnata DRUG

100 mg/single dose/1 hour before dental surgery

Passiflora incarnata

midazolam DRUG

15 mg/single dose/1 hour before dental surgery

Also known as: Dormonid

midazolam

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Sergipe: lead
• University of Campinas, Brazil: collaborator

Study Sites (1)

Federal University of Sergipe

Aracaju, Sergipe, 49060-100, Brazil

Location

Related Publications (2)

• 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.

  PMID: 19441926 BACKGROUND

• 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.

  PMID: 17268084 BACKGROUND

Related Links

• published article

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Liane M Souza, PhD

  Federal University of Sergipe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2014
• First Posted: February 19, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 28, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)