Anesthesia, LocalNCT03423329
Effectiveness of Buccal Infiltration During Vital Pulpotomy After Administering Two Analgesic Premedications
A study testing Brufen and Cital in people with Anesthesia, Local, run by Ain Shams University at 1 site in Egypt.
Trial summary
This Randomized study was designed to assess and compare the effect of two analgesic premedications (Ibuprofen BP 100 mg/5 ml and Paracetamol 200 mg/5ml.) on the anesthetic efficacy of buccal infiltration in vital pulpotomy of primary mandibular molars in children . Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Brufen and Cital
- 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 siteEgypt
- Study dates
- 20 Jan 2018to 25 Apr 2018
- 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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age group 7-9 years
- Patients medically free.
- Patients who can be categorized as cooperative or potentially cooperative according to Wright's classification for child behavior
- Patients able to understand the use of pain scales;
- Having at least one lower second primary molar with deep caries indicated for pulpotomy;
- A vital coronal pulp on access opening of designated molar.
Who cannot join
- Patients with allergic reactions, sensitivity, or contraindications to any tested drugs
- Patients who had taken analgesics within 12 hours before administration of the study drugs
- Patients having active pain, pulpitis or abscess related to the designated mandibular molar.
- Children with special health care needs or any systemic problems
- Presence of periapical or furcation radiolucency on radiographs in relation to designated molar
- Presence of of any signs of internal or external resorption on radiographs in relation to designated molar
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Oral Administration of Ibuprofen and Acetaminophen on the Anesthetic Efficacy of Buccal Infiltration During Vital Pulpotomy of Mandibular Primary Molars: A Prospective, Double-blinded, Randomized Controlled Trial
This Randomized study was designed to assess and compare the effect of two analgesic premedications (Ibuprofen BP 100 mg/5 ml and Paracetamol 200 mg/5ml.) on the anesthetic efficacy of buccal infiltration in vital pulpotomy of primary mandibular molars in children . A multivitamin with the same color as the twp tested medications will be administered to children in the control group. Parents of eligible children will be informed about the nature of the procedure, the purpose of the study, any possible discomfort or risks and a signed informed consent will be obtained from them prior to enrollment.
Read the detailed description
A total of 60 healthy children will be recruited from the outpatient clinic of the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Ain Shams University.
Inclusion Criteria include: age group 7-9 years Without systemic or mental disorders. Who could be categorized as cooperative according to Wright's classification for child behavior Ability of child to understand the use of pain scales; Having at least one lower second primary molar with deep caries indicated for pulpotomy; Absence of any periapical or furcation radiolucency on radiographs, Absence of any signs of internal or external resorption on radiographs, A vital coronal pulp on access opening.
. Patients who had taken analgesics within 12 hours before administration of the study drugs or those having active pain, pulpitis or abscess related to the designated mandibular molar will not be included.
To ensure randomization and allocation concealment, children will be randomly assigned to the three groups using computer-generated numbers.
One operator will do pulpotomy for all participants and to ensure blinding, another author ( will give the premedication to children.Pain during pulpotomy will be assessed using Wong Baker FACES pain assessment tool.
- Conditions
- Anesthesia, Local
- Being tested
- Brufen, Cital, Placebo for Brufen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrufenDrug
Also called Advil, Nurfen
Brufen Syrup
CitalDrug
Also called Paramol
Cital Cyrup
Placebo for BrufenDrug
Also called Placebo for Cital
Sansovit Syrup
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Intervention:Drug: Brufen \& Placebo
Brufen syrup 10 ml, once, 1 hour before local anesthesia Receives: Drug: Brufen; Drug: Placebo for Brufen |
| Group B | Experimental | Intervention: Drug: Cital and Placebo
Cital Syrup 10 ml, once 1 hour before Local anesthesia Receives: Drug: Cital; Drug: Placebo for Brufen |
| Group C | Placebo comparator | Intervention: Drug: Placebo
Other names:
(Placebo for Brufen) (Placebo for Cital)
Sansovit Iron Multivitamin syrup, an orange-coloured, orange-flavoured Receives: Drug: Brufen; Drug: Cital; Drug: Placebo for Brufen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain/discomfort felt during vital pulpotomy of mandibular second primary molars
Using Wong Baker FACES pain assessment tool Children will be asked to rate any pain felt during coronal access
Measured: 75 minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start20 Jan 2018
- Primary completion25 Apr 2018
- Study completion25 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Abou El Fadl, Ain Shams University
- Investigators
- Reham Abou El Fadl, DDS, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423329
- Sponsor's protocol ID
- FDASU-REC R 071607
- Status last verified
- Nov 2018
- First submitted
- 28 Dec 2017
- Last updated
- 15 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Oral Administration of Ibuprofen and Acetaminophen on the Anesthetic Efficacy of Buccal Infiltration During Vital Pulpotomy of Mandibular Primary Molars: A Prospective, Double-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03423329
- Acronym / sponsor ID
- FDASU-REC R 071607
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 6 Feb 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.
This Randomized study was designed to assess and compare the effect of two analgesic premedications (Ibuprofen BP 100 mg/5 ml and Paracetamol 200 mg/5ml.) on the anesthetic efficacy of buccal infiltration in vital pulpotomy of primary mandibular molars in children . A multivitamin with the same color as the twp tested medications will be administered to children in the control group. Parents of eligible children will be informed about the nature of the procedure, the purpose of the study, any possible discomfort or risks and a signed informed consent will be obtained from them prior to enrollment.
Detailed description
A total of 60 healthy children will be recruited from the outpatient clinic of the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Ain Shams University.
Inclusion Criteria include: age group 7-9 years Without systemic or mental disorders. Who could be categorized as cooperative according to Wright's classification for child behavior Ability of child to understand the use of pain scales; Having at least one lower second primary molar with deep caries indicated for pulpotomy; Absence of any periapical or furcation radiolucency on radiographs, Absence of any signs of internal or external resorption on radiographs, A vital coronal pulp on access opening.
. Patients who had taken analgesics within 12 hours before administration of the study drugs or those having active pain, pulpitis or abscess related to the designated mandibular molar will not be included.
To ensure randomization and allocation concealment, children will be randomly assigned to the three groups using computer-generated numbers.
One operator will do pulpotomy for all participants and to ensure blinding, another author ( will give the premedication to children.Pain during pulpotomy will be assessed using Wong Baker FACES pain assessment tool.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Brufen, Drug: Placebo for BrufenIntervention:Drug: Brufen \& Placebo Brufen syrup 10 ml, once, 1 hour before local anesthesia |
| Group B | Experimental | Drug: Cital, Drug: Placebo for BrufenIntervention: Drug: Cital and Placebo Cital Syrup 10 ml, once 1 hour before Local anesthesia |
| Group C | Placebo comparator | Drug: Brufen, Drug: Cital, Drug: Placebo for BrufenIntervention: Drug: Placebo Other names: (Placebo for Brufen) (Placebo for Cital) Sansovit Iron Multivitamin syrup, an orange-coloured, orange-flavoured |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- age group 7-9 years
- Patients medically free.
- Patients who can be categorized as cooperative or potentially cooperative according to Wright's classification for child behavior
- Patients able to understand the use of pain scales;
- Having at least one lower second primary molar with deep caries indicated for pulpotomy;
Key exclusion criteria (6 listed)
- Patients with allergic reactions, sensitivity, or contraindications to any tested drugs
- Patients who had taken analgesics within 12 hours before administration of the study drugs
- Patients having active pain, pulpitis or abscess related to the designated mandibular molar.
- Children with special health care needs or any systemic problems
- Presence of periapical or furcation radiolucency on radiographs in relation to designated molar
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 |
|---|---|---|
| BrufenAlso: Advil, NurfenBrufen Syrup | Drug | Group A, Group C |
| CitalAlso: ParamolCital Cyrup | Drug | Group B, Group C |
| Placebo for BrufenAlso: Placebo for CitalSansovit Syrup | Drug | Group A, Group B, Group C |
Primary outcome
Pain/discomfort felt during vital pulpotomy of mandibular second primary molars
Time frame: 75 minutes after drug administration
Using Wong Baker FACES pain assessment tool Children will be asked to rate any pain felt during coronal access
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 15 Nov 2018.
- Individual participant dataSharing planned: Yes
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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.
Reham Abou El Fadl, DDS principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brufen and Cital in people with Anesthesia, Local, run by Ain Shams University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 15 Nov 2018. 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 Egypt. 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?
Pain/discomfort felt during vital pulpotomy of mandibular second primary molars (time frame: 75 minutes after drug administration). 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 15 Nov 2018.