Dental AnxietyPhase 2/3NCT02065843
Three Anxiolytic Drugs Used in Third Molar Surgery
A Phase 2/3 study testing Mulungu, Passiflora incarnata and midazolam in people with Dental Anxiety and Impacted Third Molar Tooth, run by Universidade Federal de Sergipe at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Impacted Third Molar Tooth
- What is being tested?
- Mulungu, Passiflora incarnata and midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Sep 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- indication of bilateral extraction of asymptomatic, impacted mandibular third molars
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of the Effectiveness of Three Anxiolytic Drugs Used in Third Molar Surgery
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.
Read the detailed description
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
- Dental Anxiety, Impacted Third Molar Tooth
- Being tested
- Mulungu, Placebo, Passiflora incarnata, midazolam
- Keywords
- Anxiety, Third molar surgery, Blood pressure, Heart rate, Oxygen saturation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MulunguDrug
Also called Mulungu Matusa, Erytrina mulungu
500 mg/single dose/1 hour before dental surgery
PlaceboDrug
500 mg/single dose/1 hour before dental surgery
Passiflora incarnataDrug
100 mg/single dose/1 hour before dental surgery
midazolamDrug
Also called Dormonid
15 mg/single dose/1 hour before dental surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 7 days
Secondary outcomes (3)
Changes in blood pressure
blood pressure (mmHg) will be measured before the drugs administration, 30 minutes after drugs administration and during local anesthesia, incision, tooth removal and suturing.
Measured: Change from baseline to 2 hours
Changes in heart rate
heart rate (bpm) will be measured before drugs administration, 30 minutes after drugs administration and during local anesthesia, incision, tooth removal and suturing.
Measured: Change from baseline to 2 hours
Changes in oxygen saturation
oxygen saturation (SpO2) will be measured before drugs administration, 30 minutes after drugs administration and during local anesthesia, incision, tooth removal and suturing.
Measured: Change from baseline to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sergipe
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campinas, Brazil
- Responsible party
- Principal investigator, Liane Maciel de Almeida Souza, Universidade Federal de Sergipe
- Investigators
- Liane M Souza, PhD, Principal investigator, Federal University of Sergipe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065843
- Sponsor's protocol ID
- ANSI-388.427
- Status last verified
- Oct 2016
- First submitted
- 15 Feb 2014
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: IPD will be kept not available
Publications
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.
PubMed 19441926Flausino 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.
PubMed 17268084
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Effectiveness of Three Anxiolytic Drugs Used in Third Molar Surgery
- ClinicalTrials.gov ID
- NCT02065843
- Acronym / sponsor ID
- ANSI-388.427
- Conditions
- Dental Anxiety, Impacted Third Molar Tooth
- Keywords
- Anxiety, Third molar surgery, Blood pressure, Heart rate, Oxygen saturation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Federal de SergipeUniversity, hospital or other
- Collaborators
- University of Campinas, Brazil
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mulungu | Active comparator | Drug: Mulungu500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure. |
| placebo | Placebo comparator | Drug: Placebo500 mg of starch (2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure. |
| Passiflora incarnata | Active comparator | Drug: Passiflora incarnata100 mg Passiflora incarnata (2 capsules of 50 mg) to be administered v.o., one hour before the surgical procedure. |
| midazolam | Active comparator | Drug: midazolam15 mg midazolam (2 capsules of 7.5 mg) to be administered v.o., one hour before the surgical procedure. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- indication of bilateral extraction of asymptomatic, impacted mandibular third molars
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MulunguAlso: Mulungu Matusa, Erytrina mulungu500 mg/single dose/1 hour before dental surgery | Drug | Mulungu |
| Placebo500 mg/single dose/1 hour before dental surgery | Drug | placebo |
| Passiflora incarnata100 mg/single dose/1 hour before dental surgery | Drug | Passiflora incarnata |
| midazolamAlso: Dormonid15 mg/single dose/1 hour before dental surgery | Drug | midazolam |
Primary outcome
Changes in anxiety report
Time frame: Change from baseline to 7 days
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.
3 secondary outcomes
Changes in blood pressure
Time frame: Change from baseline to 2 hours
Changes in heart rate
Time frame: Change from baseline to 2 hours
Changes in oxygen saturation
Time frame: Change from baseline to 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Background: PubMed 19441926Balbani 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.
- Background: PubMed 17268084Flausino 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.
- published articleLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will be kept not available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liane M Souza, PhD principal investigator
Federal University of Sergipe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mulungu, Passiflora incarnata and midazolam in people with Dental Anxiety and Impacted Third Molar Tooth, run by Universidade Federal de Sergipe at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in anxiety report (time frame: Change from baseline to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02065843, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.