AnxietyPhase 2NCT01784250
Efficacy of Clonidine and Propranolol in Dentistry (AAA)
A Phase 2 study testing Clonidine and Propranolol in people with Anxiety, run by CES University at 1 site in Colombia.
Trial summary
The aim of the study is to determine the efficacy of clonidine and propranolol for transient anxiety management and intra and postoperative pain in patients undergoing ambulatory surgery of third molar. Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Clonidine and Propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteColombia
- Study dates
- Aug 2012to Apr 2013
- Phase
- Phase 2
- 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 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Normotensive patients and pre-hypertension who are undergoing elective surgery for removal of third molars.
- Age range 14 to 40 years
- Patients with dental anxiety above 13 points on the scale (MDAS).
- People who voluntarily agree to participate in the study and sign the informed consent form
Who cannot join
- Patients receiving any medication for any chronic pathology.
- Patients of African American race, being more likely to have abnormal blood pressure.
- Patients with a history of cardiovascular disease.
- Patients with chronic systemic disease such as diabetes, hyper or hypothyroidism, Addison's syndrome, renal failure, hypertension or liver disease.
- Pregnant or breastfeeding.
- Patients diagnosed with anxiety disorder or depressive disorder
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Cooperative University
Envigado, Antioquia
Patricia Bermudez, Dentistry, patvanss@hotmail.com
Ana K Tamara, Physician, anakarinatamarae@hotmail.com
About this study
Official title: Efficacy of Clonidine and Propranolol Versus Placebo for the Control of Anxiety During Surgical Procedures in Dentistry
The aim of the study is to determine the efficacy of clonidine and propranolol for transient anxiety management and intra and postoperative pain in patients undergoing ambulatory surgery of third molar.
Read the detailed description
There will be a randomized, triple-blind, placebo-controlled clinical trial with parallel group design to determine the efficacy of the pre medication propranolol and clonidine versus placebo for reducing anxiety during third molar removal surgery. Patients will be assigned to 3 groups of 20 patients each. One group will receive 150 mcg of clonidine, the second group will receive propranolol 40mg, and the control group will receive placebo. The modified dental anxiety scale will be applied before and after surgery in order to evaluate the change in anxiety level, which will be assessed as the primary outcome. The secondary outcomes include the measurement of changes in blood pressure, heart rate and respiratory rate evaluated before, during and after surgery. Additionally, pain will be assessed through numerical pain scale at 3, 6 and 24 hours after surgery. Also, possible side effects will be identified (vomiting, nausea, dry mouth, dizziness and drowsiness). Statistical analysis: qualitative variables will be described by absolute and relative frequencies, and quantitative variables will be described by the mean along with standard deviation or the median with interquartile range depending on the distribution of the data. One-way ANOVA or Kruskal Wallis will be used (depending on the fulfillment of assumptions) in order to compare the quantitative variables amongst the groups. The chi squared test will be used to compare the qualitative variables. The confidence intervals will be estimated at 95% for all effect magnitude measurements calculated.
- Conditions
- Anxiety
- Being tested
- Clonidine, Propranolol, Placebo
- Keywords
- Clonidine, Propranolol, Third molar, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
Also called Catapresan
Clonidine 150 mcg tablet single dose, to receive by mouth one hour before surgery
PropranololDrug
Also called Artensol, Inderal
Propranolol 40 mg tablet single dose, to receive by mouth one hour before surgery
PlaceboDrug
Sugar pill manufactured to mimic a drug
| Study group | Role | What they receive |
|---|---|---|
| Propanolol | Experimental | Propranolol 40mg tablets, one tablet administered 1 hour before surgery Receives: Drug: Propranolol |
| Placebo | Placebo comparator | Placebo tablets, one tablet administered 1 hour before surgery Receives: Drug: Placebo |
| Clonidine | Experimental | clonidine 150mcg tablets, one tablet administered 1 hour before surgery Receives: Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in modified dental anxiety scale(MDAS)and vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation) until four hours post treatment
Measured: (plus or minus 4 hours) after surgery
Secondary outcomes (1)
Changes in Verbal Numerical Rating Scale (VNRS) at three, six, and twenty-four hours post treatment
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startAug 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Bermúdez Reyes, CES University
- Investigators
- Patricia Bermudez, Dentistry, Principal investigator, CES UniversityLibia M Rodriguez, Magister, Study director, CES UniversityAna K Tamara, Physician, Principal investigator, CES University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784250
- Sponsor's protocol ID
- CLON000
- Status last verified
- Feb 2013
- First submitted
- 23 Jan 2013
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ng SK, Leung WK. A community study on the relationship of dental anxiety with oral health status and oral health-related quality of life. Community Dent Oral Epidemiol. 2008 Aug;36(4):347-56. doi: 10.1111/j.1600-0528.2007.00412.x.
PubMed 19145721Kvale G, Berggren U, Milgrom P. Dental fear in adults: a meta-analysis of behavioral interventions. Community Dent Oral Epidemiol. 2004 Aug;32(4):250-64. doi: 10.1111/j.1600-0528.2004.00146.x.
PubMed 15239776Lago-Mendez L, Diniz-Freitas M, Senra-Rivera C, Seoane-Pesqueira G, Gandara-Rey JM, Garcia-Garcia A. Postoperative recovery after removal of a lower third molar: role of trait and dental anxiety. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Dec;108(6):855-60. doi: 10.1016/j.tripleo.2009.07.021.
PubMed 19913724Humphris GM, Dyer TA, Robinson PG. The modified dental anxiety scale: UK general public population norms in 2008 with further psychometrics and effects of age. BMC Oral Health. 2009 Aug 26;9:20. doi: 10.1186/1472-6831-9-20.
PubMed 19709436Hall DL, Tatakis DN, Walters JD, Rezvan E. Oral clonidine pre-treatment and diazepam/meperidine sedation. J Dent Res. 2006 Sep;85(9):854-8. doi: 10.1177/154405910608500915.
PubMed 16931871Liu HH, Milgrom P, Fiset L. Effect of a beta-adrenergic blocking agent on dental anxiety. J Dent Res. 1991 Sep;70(9):1306-8. doi: 10.1177/00220345910700091401.
PubMed 1918581Herr KA, Spratt K, Mobily PR, Richardson G. Pain intensity assessment in older adults: use of experimental pain to compare psychometric properties and usability of selected pain scales with younger adults. Clin J Pain. 2004 Jul-Aug;20(4):207-19. doi: 10.1097/00002508-200407000-00002.
PubMed 15218405
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Clonidine and Propranolol Versus Placebo for the Control of Anxiety During Surgical Procedures in Dentistry
- ClinicalTrials.gov ID
- NCT01784250
- Acronym / sponsor ID
- CLON000
- Conditions
- Anxiety
- Keywords
- Clonidine, Propranolol, Third molar, Anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 5 Feb 2013 (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 study is to determine the efficacy of clonidine and propranolol for transient anxiety management and intra and postoperative pain in patients undergoing ambulatory surgery of third molar.
Detailed description
There will be a randomized, triple-blind, placebo-controlled clinical trial with parallel group design to determine the efficacy of the pre medication propranolol and clonidine versus placebo for reducing anxiety during third molar removal surgery. Patients will be assigned to 3 groups of 20 patients each. One group will receive 150 mcg of clonidine, the second group will receive propranolol 40mg, and the control group will receive placebo. The modified dental anxiety scale will be applied before and after surgery in order to evaluate the change in anxiety level, which will be assessed as the primary outcome. The secondary outcomes include the measurement of changes in blood pressure, heart rate and respiratory rate evaluated before, during and after surgery. Additionally, pain will be assessed through numerical pain scale at 3, 6 and 24 hours after surgery. Also, possible side effects will be identified (vomiting, nausea, dry mouth, dizziness and drowsiness). Statistical analysis: qualitative variables will be described by absolute and relative frequencies, and quantitative variables will be described by the mean along with standard deviation or the median with interquartile range depending on the distribution of the data. One-way ANOVA or Kruskal Wallis will be used (depending on the fulfillment of assumptions) in order to compare the quantitative variables amongst the groups. The chi squared test will be used to compare the qualitative variables. The confidence intervals will be estimated at 95% for all effect magnitude measurements calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propanolol | Experimental | Drug: PropranololPropranolol 40mg tablets, one tablet administered 1 hour before surgery |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets, one tablet administered 1 hour before surgery |
| Clonidine | Experimental | Drug: Clonidineclonidine 150mcg tablets, one tablet administered 1 hour before surgery |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Normotensive patients and pre-hypertension who are undergoing elective surgery for removal of third molars.
- Age range 14 to 40 years
- Patients with dental anxiety above 13 points on the scale (MDAS).
- People who voluntarily agree to participate in the study and sign the informed consent form
Key exclusion criteria (6 listed)
- Patients receiving any medication for any chronic pathology.
- Patients of African American race, being more likely to have abnormal blood pressure.
- Patients with a history of cardiovascular disease.
- Patients with chronic systemic disease such as diabetes, hyper or hypothyroidism, Addison's syndrome, renal failure, hypertension or liver disease.
- Pregnant or breastfeeding.
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 |
|---|---|---|
| ClonidineAlso: CatapresanClonidine 150 mcg tablet single dose, to receive by mouth one hour before surgery | Drug | Clonidine |
| PropranololAlso: Artensol, InderalPropranolol 40 mg tablet single dose, to receive by mouth one hour before surgery | Drug | Propanolol |
| PlaceboSugar pill manufactured to mimic a drug | Drug | Placebo |
Primary outcome
Change from baseline in modified dental anxiety scale(MDAS)and vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation) until four hours post treatment
Time frame: (plus or minus 4 hours) after surgery
1 secondary outcome
Changes in Verbal Numerical Rating Scale (VNRS) at three, six, and twenty-four hours post treatment
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
- Background: PubMed 19145721Ng SK, Leung WK. A community study on the relationship of dental anxiety with oral health status and oral health-related quality of life. Community Dent Oral Epidemiol. 2008 Aug;36(4):347-56. doi: 10.1111/j.1600-0528.2007.00412.x.
- Background: PubMed 15239776Kvale G, Berggren U, Milgrom P. Dental fear in adults: a meta-analysis of behavioral interventions. Community Dent Oral Epidemiol. 2004 Aug;32(4):250-64. doi: 10.1111/j.1600-0528.2004.00146.x.
- Background: PubMed 19913724Lago-Mendez L, Diniz-Freitas M, Senra-Rivera C, Seoane-Pesqueira G, Gandara-Rey JM, Garcia-Garcia A. Postoperative recovery after removal of a lower third molar: role of trait and dental anxiety. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Dec;108(6):855-60. doi: 10.1016/j.tripleo.2009.07.021.
- Background: PubMed 19709436Humphris GM, Dyer TA, Robinson PG. The modified dental anxiety scale: UK general public population norms in 2008 with further psychometrics and effects of age. BMC Oral Health. 2009 Aug 26;9:20. doi: 10.1186/1472-6831-9-20.
- Background: PubMed 16931871Hall DL, Tatakis DN, Walters JD, Rezvan E. Oral clonidine pre-treatment and diazepam/meperidine sedation. J Dent Res. 2006 Sep;85(9):854-8. doi: 10.1177/154405910608500915.
- Background: PubMed 1918581Liu HH, Milgrom P, Fiset L. Effect of a beta-adrenergic blocking agent on dental anxiety. J Dent Res. 1991 Sep;70(9):1306-8. doi: 10.1177/00220345910700091401.
- Background: PubMed 15218405Herr KA, Spratt K, Mobily PR, Richardson G. Pain intensity assessment in older adults: use of experimental pain to compare psychometric properties and usability of selected pain scales with younger adults. Clin J Pain. 2004 Jul-Aug;20(4):207-19. doi: 10.1097/00002508-200407000-00002.
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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.
Patricia Bermudez, Dentistry principal investigator
CES University
Libia M Rodriguez, Magister study director
CES University
Ana K Tamara, Physician principal investigator
CES University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clonidine and Propranolol in people with Anxiety, run by CES University at 1 site in Colombia.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Feb 2013. 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 Colombia. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in modified dental anxiety scale(MDAS)and vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation) until four hours post treatment (time frame: (plus or minus 4 hours) after surgery). 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 NCT01784250, which also lists 7 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 5 Feb 2013.