Extrusion of ToothNCT03388957
Oral Propranolol for Reducing Pediatric Dental Patients Anxiety
A study testing Propranolol and Midazolam in people with Extrusion of Tooth, run by Damascus University at 1 site in Syria.
Trial summary
Evaluating anxiety, heart rate and behavior during dental extractions after oral dose of either Propranolol, Midazolam or a combination of both in uncooperative pediatric patients. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Extrusion of Tooth
- What is being tested?
- Propranolol and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSyria
- Study dates
- 30 Jul 2018to 15 Feb 2020
- 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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- High to extreme fear of tooth or molar anesthesia and removal (Frankl: Definitely negative).
- Scoring more than 19 points on MCDAS(f).
- Healthy pediatric patients (ASA I) aging 8-10 years.
- Indication for primary tooth or molar extraction.
- Fasting if indicated (severe gag reflex).
- Airway assessment (Mallampati and tonsillar hypertrophy).
Who cannot join
- Asthma or any other obstructive pulmonary disease.
- Cardiac failure.
- Cardiac arrhythmia.
- Renal failure.
- Diabetes.
- Current use of another ß-adrenoreceptor antagonist.
Show all 11Show fewer
- Current use of anxiolytic or antidepressant medication.
- Currently in psychotherapy for dental anxiety.
- Systolic blood pressure <100 mmHg.
- Diastolic blood pressure <60 mmHg.
- Active Upper respiratory infection.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Peadodontics, University of Damascus Dental School
Damascus, DM20AM18
About this study
Official title: Evaluating of Oral Propranolol Effect on Managing Anxiety of Dental Extractions in Children: A Randomized Controlled Clinical Trial
Evaluating anxiety, heart rate and behavior during dental extractions after oral dose of either Propranolol, Midazolam or a combination of both in uncooperative pediatric patients.
Read the detailed description
Use of 0.5 mg/kg of Propranolol or a combination of Propranolol and Midazolam for the first time to manage uncooperative pediatric dental patients anxiety, comparing with Midazolam by evaluating anxiety, heart rate and behavior during administration of local anesthesia and extraction.
- Conditions
- Extrusion of Tooth
- Being tested
- Propranolol, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
This drug will be given before the extraction procedure
MidazolamDrug
This drug will be given before the extraction procedure
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Experimental | Patients in this group will be given Propranolol 0.5 mg/Kg orally. Receives: Drug: Propranolol |
| Midazolam | Experimental | Patients in this group will be given Midazolam 0.5 mg/Kg orally. Receives: Drug: Midazolam |
| Propranolol and Midazolam | Experimental | Patients in this group will be given Propranolol and Midazolam with a dose of 0.5 mg/Kg orally for each drug. Receives: Drug: Propranolol; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety-1 levels
Anxiety-1 levels will be evaluated using self-reported faces anxiety scale (also called 'modified child dental anxiety scale). Scale name: Modified Child Dental Anxiety Scale (MCDAS):
- Relaxed/Not worried. (Better outcome)
- Very slightly worried.
- Fairly worried.
- Worried a lot.
- Very worried. (Worse outcome)
Measured: (1) five minutes before medication, (2) 30 minutes post-extraction
Change in Anxiety-2 levels
Anxiety-2 levels will be measured using Observational Venham Anxiety Scale
Major Issues: 1) Will be measured in 2 phases:
- 45 minutes after medication, while applying local anesthesia.
- While extracting the tooth. "Venham Anxiety Scale": 0. Relaxed. (Better outcome)
- Uneasy.
- Tense.
- Reluctant.
- Interference.
- Out of contact. (Worse outcome)
Measured: (1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction.
Change in heart rate
using Finger Pulse Oximeter
Measured: (1) 5 minutes before medication, (2) 45 minutes after medication, while applying local anesthesia, (3) after 10 minutes of applying the anesthesia and during tooth extraction, (4) 30 minutes following extraction
Secondary outcomes (1)
Change in Behavior
using Observational Frankl Scale "Frankl Scale":
- Definitely negative. (Worse outcome)
- Negative.
- Positive.
- Definitely positive. (Better outcome)
Measured: (1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start30 Jul 2018
- Primary completion1 Oct 2019
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Extrusion of ToothStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups, with 20 children in each group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omar Abu Bakr, DDS, Principal investigator, MSc student in Pedodontics, University of Damascus Dental School, Damascus, SyriaMohamed Altinawi, DDS MSc PhD, Study chair, Professor of Pedodontics, University of Damascus Dental School, Damascus, SYRIAYoussef Latifeh, MD MSc Phd, Study director, Professor and Head of the Psychiatry Department, Damascus Univesrity, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388957
- Sponsor's protocol ID
- UDDS-Pedo-02-2017
- Status last verified
- Mar 2021
- First submitted
- 18 Dec 2017
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cote CJ, Wilson S; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016 Jul;138(1):e20161212. doi: 10.1542/peds.2016-1212.
PubMed 27354454Gazal G, Fareed WM, Zafar MS, Al-Samadani KH. Pain and anxiety management for pediatric dental procedures using various combinations of sedative drugs: A review. Saudi Pharm J. 2016 Jul;24(4):379-85. doi: 10.1016/j.jsps.2014.04.004. Epub 2014 Apr 26.
PubMed 27330369Heaton LJ, McNeil DW, Milgrom P. Propranolol and D-cycloserine as adjunctive medications in reducing dental fear in sedation practice. SAAD Dig. 2010 Jan;26:27-35.
PubMed 20151608LeCompte MT, Rae L, Kahn SA. A survey of the use of propranolol in burn centers: Who, what, when, why. Burns. 2017 Feb;43(1):121-126. doi: 10.1016/j.burns.2016.07.007. Epub 2016 Aug 27.
PubMed 27575676Steenen SA, van Wijk AJ, van der Heijden GJ, van Westrhenen R, de Lange J, de Jongh A. Propranolol for the treatment of anxiety disorders: Systematic review and meta-analysis. J Psychopharmacol. 2016 Feb;30(2):128-39. doi: 10.1177/0269881115612236. Epub 2015 Oct 20.
PubMed 26487439
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating of Oral Propranolol Effect on Managing Anxiety of Dental Extractions in Children: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03388957
- Acronym / sponsor ID
- UDDS-Pedo-02-2017
- Conditions
- Extrusion of Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 3 Jan 2018 (actual)
- 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.
Evaluating anxiety, heart rate and behavior during dental extractions after oral dose of either Propranolol, Midazolam or a combination of both in uncooperative pediatric patients.
Detailed description
Use of 0.5 mg/kg of Propranolol or a combination of Propranolol and Midazolam for the first time to manage uncooperative pediatric dental patients anxiety, comparing with Midazolam by evaluating anxiety, heart rate and behavior during administration of local anesthesia and extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups, with 20 children in each group
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Experimental | Drug: PropranololPatients in this group will be given Propranolol 0.5 mg/Kg orally. |
| Midazolam | Experimental | Drug: MidazolamPatients in this group will be given Midazolam 0.5 mg/Kg orally. |
| Propranolol and Midazolam | Experimental | Drug: Propranolol, Drug: MidazolamPatients in this group will be given Propranolol and Midazolam with a dose of 0.5 mg/Kg orally for each drug. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- High to extreme fear of tooth or molar anesthesia and removal (Frankl: Definitely negative).
- Scoring more than 19 points on MCDAS(f).
- Healthy pediatric patients (ASA I) aging 8-10 years.
- Indication for primary tooth or molar extraction.
- Fasting if indicated (severe gag reflex).
Key exclusion criteria (11 listed)
- Asthma or any other obstructive pulmonary disease.
- Cardiac failure.
- Cardiac arrhythmia.
- Renal failure.
- Diabetes.
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 |
|---|---|---|
| PropranololThis drug will be given before the extraction procedure | Drug | Propranolol, Propranolol and Midazolam |
| MidazolamThis drug will be given before the extraction procedure | Drug | Midazolam, Propranolol and Midazolam |
Primary outcome
Change in Anxiety-1 levels
Time frame: (1) five minutes before medication, (2) 30 minutes post-extraction
Anxiety-1 levels will be evaluated using self-reported faces anxiety scale (also called 'modified child dental anxiety scale). Scale name: Modified Child Dental Anxiety Scale (MCDAS): 1. Relaxed/Not worried. (Better outcome) 2. Very slightly worried. 3. Fairly worried. 4. Worried a lot. 5. Very worried. (Worse outcome)
Change in Anxiety-2 levels
Time frame: (1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction.
Anxiety-2 levels will be measured using Observational Venham Anxiety Scale Major Issues: 1) Will be measured in 2 phases: * 45 minutes after medication, while applying local anesthesia. * While extracting the tooth. "Venham Anxiety Scale": 0. Relaxed. (Better outcome) 1. Uneasy. 2. Tense. 3. Reluctant. 4. Interference. 5. Out of contact. (Worse outcome)
Change in heart rate
Time frame: (1) 5 minutes before medication, (2) 45 minutes after medication, while applying local anesthesia, (3) after 10 minutes of applying the anesthesia and during tooth extraction, (4) 30 minutes following extraction
using Finger Pulse Oximeter
1 secondary outcome
Change in Behavior
Time frame: (1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction
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 24 Mar 2021.
- Background: PubMed 27354454Cote CJ, Wilson S; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016 Jul;138(1):e20161212. doi: 10.1542/peds.2016-1212.
- Background: PubMed 27330369Gazal G, Fareed WM, Zafar MS, Al-Samadani KH. Pain and anxiety management for pediatric dental procedures using various combinations of sedative drugs: A review. Saudi Pharm J. 2016 Jul;24(4):379-85. doi: 10.1016/j.jsps.2014.04.004. Epub 2014 Apr 26.
- Background: PubMed 20151608Heaton LJ, McNeil DW, Milgrom P. Propranolol and D-cycloserine as adjunctive medications in reducing dental fear in sedation practice. SAAD Dig. 2010 Jan;26:27-35.
- Background: PubMed 27575676LeCompte MT, Rae L, Kahn SA. A survey of the use of propranolol in burn centers: Who, what, when, why. Burns. 2017 Feb;43(1):121-126. doi: 10.1016/j.burns.2016.07.007. Epub 2016 Aug 27.
- Background: PubMed 26487439Steenen SA, van Wijk AJ, van der Heijden GJ, van Westrhenen R, de Lange J, de Jongh A. Propranolol for the treatment of anxiety disorders: Systematic review and meta-analysis. J Psychopharmacol. 2016 Feb;30(2):128-39. doi: 10.1177/0269881115612236. Epub 2015 Oct 20.
- Individual participant dataSharing planned: No
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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.
Omar Abu Bakr, DDS principal investigator
MSc student in Pedodontics, University of Damascus Dental School, Damascus, Syria
Mohamed Altinawi, DDS MSc PhD study chair
Professor of Pedodontics, University of Damascus Dental School, Damascus, SYRIA
Youssef Latifeh, MD MSc Phd study director
Professor and Head of the Psychiatry Department, Damascus Univesrity, Damascus, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propranolol and Midazolam in people with Extrusion of Tooth, run by Damascus University at 1 site in Syria.
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 6 inclusion and 11 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 24 Mar 2021. 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 Syria. 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. 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?
Change in Anxiety-1 levels (time frame: (1) five minutes before medication, (2) 30 minutes post-extraction). 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?
On the ClinicalTrials.gov record for NCT03388957, which also lists 5 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 24 Mar 2021.