Dental AnxietyNCT01612130
Valerian for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery
A study testing 100 mg of Valeriana officinalis L in people with Dental Anxiety and Blood Pressure, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
Trial summary
The aim of the present study was to evaluate the efficacy of Valeriana officinalis L. 100 mg in single oral doses one hour preoperative as conscious sedation during the impacted lower third molar surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Anxiety, Blood Pressure, Heart Rate
- What is being tested?
- 100 mg of Valeriana officinalis L
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2003to Aug 2003
- Phase
- Interventional
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Indication for bilateral extraction of asymptomatic impacted mandibular third molars in similar positions based on the Pell \& Gregory classification
Who cannot join
- Use of any type of medication in the 15 days prior to the onset of the study; history of hypersensitivity to the drugs, substances or materials employed in the experiment; pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Oral-Maxillofacial Surgery Sector of the Piracicaba Dental School, Universidade Estadual de Campinas (Brazil)
Piracicaba, São Paulo, 13414-903
About this study
Official title: Valeriana Officinalis L. for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery: A Randomized, Double-Blind, Placebo-Controlled Crossover Study
The aim of the present study was to evaluate the efficacy of Valeriana officinalis L. 100 mg in single oral doses one hour preoperative as conscious sedation during the impacted lower third molar surgery.
Read the detailed description
Evaluate the efficacy of Valeriana officinalis L. (Valerian) for control of anxiety during third molar surgery. Study design: A single oral dose of either valerian (100 mg) or placebo was randomly administered one hour before each surgical procedure to 20 volunteers between 17 and 31 years of age. Anxiety level was assessed through questionnaires, physiological parameters (blood pressure and heart rate) and the observation of signs.
- Conditions
- Dental Anxiety, Blood Pressure, Heart Rate
- Being tested
- 100 mg of Valeriana officinalis L, Placebo 100mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 mg of Valeriana officinalis LDrug
Also called Valerian
A single dose of 100 mg of Valeriana officinalis L., 1 hour prior to surgical procedures
Placebo 100mgDrug
A single dose of 100 mg of placebo orally, 1 hour prior to surgical procedures
| Study group | Role | What they receive |
|---|---|---|
| Valeriana officinalis L (100mg) | Experimental | 100 mg of Valeriana officinalis L. (Valerian) Receives: Drug: 100 mg of Valeriana officinalis L |
| Placebo (100 mg) | Placebo comparator | Placebo 100mg Receives: Drug: Placebo 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs and symptoms of anxiety
During each surgery, the researcher and surgeon observed the manifestation of signs and symptoms associated to anxiety (restlessness/agitation/nervous ticks, paleness, excessive perspiration, tingling sensation in hands, feet or lips, change in breathing rhythm or depth). In the presence of one or more of these signs and symptoms, the patient was classified as anxious. If there was no manifestation of anxiety, the patient was classified as calm or relaxed
Measured: 1 day (during dental appointment)
assessment of the blood pressure
The assessment of the blood pressure was performed at three moments: baseline, post-medication and end of surgery.
Measured: 1 day (during dental appointment)
Assesment of heart rate
The assessment of the heart rate was performed at three moments: baseline, post-medication and end of surgery.
Measured: 1 day (during dental appointment)
Secondary outcomes (2)
Oxygen saturation
Level of blood oxygen saturation 30 minutes after drug administration and throughout the surgical procedure.
Measured: 1 day (During dental appointment)
Side effects of drugs
Evaluation of the incidence of side effects of drugs used were informed by the patient after de drug administration until one week of postoperative period.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startMar 2003
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campinas, Brazil
- Responsible party
- Principal investigator, Marcos Luciano Pimenta Pinheiro, Federal University of the Valleys of Jequitinhonha and Mucuri
- Investigators
- Marcos Pinheiro, PhD, Principal investigator, Federal University of the Valleys of Jequitinhonha and Mucuri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612130
- Sponsor's protocol ID
- 098/2002
- Status last verified
- Jun 2012
- First submitted
- 1 Jun 2012
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valeriana Officinalis L. for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery: A Randomized, Double-Blind, Placebo-Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT01612130
- Acronym / sponsor ID
- 098/2002
- Conditions
- Dental Anxiety, Blood Pressure, Heart Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and MucuriUniversity, hospital or other
- Collaborators
- University of Campinas, Brazil
- Study start
- Mar 2003
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 5 Jun 2012 (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.
The aim of the present study was to evaluate the efficacy of Valeriana officinalis L. 100 mg in single oral doses one hour preoperative as conscious sedation during the impacted lower third molar surgery.
Detailed description
Evaluate the efficacy of Valeriana officinalis L. (Valerian) for control of anxiety during third molar surgery. Study design: A single oral dose of either valerian (100 mg) or placebo was randomly administered one hour before each surgical procedure to 20 volunteers between 17 and 31 years of age. Anxiety level was assessed through questionnaires, physiological parameters (blood pressure and heart rate) and the observation of signs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valeriana officinalis L (100mg) | Experimental | Drug: 100 mg of Valeriana officinalis L100 mg of Valeriana officinalis L. (Valerian) |
| Placebo (100 mg) | Placebo comparator | Drug: Placebo 100mgPlacebo 100mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication for bilateral extraction of asymptomatic impacted mandibular third molars in similar positions based on the Pell \& Gregory classification
Key exclusion criteria (1 listed)
- Use of any type of medication in the 15 days prior to the onset of the study; history of hypersensitivity to the drugs, substances or materials employed in the experiment; pregnancy or lactation
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 |
|---|---|---|
| 100 mg of Valeriana officinalis LAlso: ValerianA single dose of 100 mg of Valeriana officinalis L., 1 hour prior to surgical procedures | Drug | Valeriana officinalis L (100mg) |
| Placebo 100mgA single dose of 100 mg of placebo orally, 1 hour prior to surgical procedures | Drug | Placebo (100 mg) |
Primary outcome
Signs and symptoms of anxiety
Time frame: 1 day (during dental appointment)
During each surgery, the researcher and surgeon observed the manifestation of signs and symptoms associated to anxiety (restlessness/agitation/nervous ticks, paleness, excessive perspiration, tingling sensation in hands, feet or lips, change in breathing rhythm or depth). In the presence of one or more of these signs and symptoms, the patient was classified as anxious. If there was no manifestation of anxiety, the patient was classified as calm or relaxed
assessment of the blood pressure
Time frame: 1 day (during dental appointment)
The assessment of the blood pressure was performed at three moments: baseline, post-medication and end of surgery.
Assesment of heart rate
Time frame: 1 day (during dental appointment)
The assessment of the heart rate was performed at three moments: baseline, post-medication and end of surgery.
2 secondary outcomes
Oxygen saturation
Time frame: 1 day (During dental appointment)
Side effects of drugs
Time frame: 1 week
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 6 Jun 2012.
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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.
Marcos Pinheiro, PhD principal investigator
Federal University of the Valleys of Jequitinhonha and Mucuri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100 mg of Valeriana officinalis L in people with Dental Anxiety and Blood Pressure, run by Federal University of the Valleys of Jequitinhonha and Mucuri 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 6 Jun 2012. 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.
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?
Signs and symptoms of anxiety (time frame: 1 day (during dental appointment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2012.