Overcoming the Failure of AnaesthesiaPhase 4NCT04236115
Comparison of Articaine and Prilocaine for Extraction of Maxillary Teeth
A Phase 4 study testing Articaine 4%, Prilocain 3% and Adrenalin in people with Overcoming the Failure of Anaesthesia and Maxillary Teeth, run by Taibah University at 1 site in Saudi Arabia.
Trial summary
Ninety-five patients, aged between 16 and 70 years old, were included in this study. Patients were divided into two groups. Group one received Articaine 4% with 1:00.000 Adrenalines. Group two received Prilocaine with 3% Felypressin (0.03 I.U. per ml). Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Overcoming the Failure of Anaesthesia, Maxillary Teeth, Dental Extraction
- What is being tested?
- Articaine 4%, Prilocain 3% and Adrenalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Sep 2017to 20 Jun 2018
- Phase
- Phase 4
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients have one or two upper teeth for extraction, subject tooth or its adjacent must be vital, healthy patient or patient with mild systemic diseases (class I or II according to American Society of Anesthesiology).
Who cannot join
- Patients excluded from this study if they have allergy to local anaesthetic agents or need surgical, or multiple teeth extraction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Articaine, Rather Than Prilocaine, Increase the Success Rate of Anaesthesia for Extraction of Maxillary Teeth
Ninety-five patients, aged between 16 and 70 years old, were included in this study. Patients were divided into two groups. Group one received Articaine 4% with 1:00.000 Adrenalines. Group two received Prilocaine with 3% Felypressin (0.03 I.U. per ml). Onset time of anaesthesia was objectively evaluated by using electronic pulp testing.
Read the detailed description
85 patients in this study had successful local anaesthetic followed by extraction within the study duration time (10 minutes). However, there were six patients with failure anaesthesia (5 in prilocaine group and 1 in articaine group). By application Person's Chi-square test (x2), there were no significant differences in the number of the episodes of the anaesthetic success between articaine and prilocaine groups at time intervals (P-value = 0.5). T- test showed there have been no important variations within the mean onset time of anaesthesia for articaine and prilocaine buccal infiltrations (P-value =0.1).
- Being tested
- Articaine 4%, Prilocain 3%, Adrenalin, Felypressin
- Keywords
- Carticaine, dental extraction, injections, prilocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articaine 4%Drug
Articaine 4% is dental local anaesthetic agent
Prilocain 3%Drug
prilocaine is dental local anaesthetic agent
AdrenalinDrug
adrenaline is a vasoconstrictor
FelypressinDrug
Felypressin is a vasoconstrictor
| Study group | Role | What they receive |
|---|---|---|
| Articaine 4% with 1:00.000 Adrenaline | Active comparator | if the patient was in articaine group, buccal infiltration technique was applied by inserting a short needle at the height of buccal sulcus along the long axis of the subject tooth for extraction. Receives: Drug: Articaine 4%; Drug: Adrenalin |
| Prilocaine with 3% Felypressin (0.03 I.U. per ml) | Active comparator | if the patient was in prelocaine group, buccal infiltration technique was applied by inserting a short needle at the height of buccal sulcus along the long axis of the subject tooth for extraction. Receives: Drug: Prilocain 3%; Drug: Felypressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does articaine, rather than prilocaine, increase the success rate of anaesthesia for extraction of maxillary teeth
to compare the anaesthetic performances of 3% prilocaine (the safest local anaesthetic) with 4 % articaine (the local anaesthetic with fastest onset time of action) when used for maxillary teeth extraction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start20 Sep 2017
- Primary completion20 Apr 2018
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overcoming the Failure of AnaesthesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blinded randomised trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taibah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giath Gazal, Taibah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236115
- Sponsor's protocol ID
- Taibah dental College
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: it will be provided on demand
Publications
Gazal G. Does articaine, rather than prilocaine, increase the success rate of anaesthesia for extraction of maxillary teeth. Saudi J Anaesth. 2020 Jul-Sep;14(3):297-301. doi: 10.4103/sja.SJA_94_20. Epub 2020 May 30.
PubMed 32934619
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Articaine, Rather Than Prilocaine, Increase the Success Rate of Anaesthesia for Extraction of Maxillary Teeth
- ClinicalTrials.gov ID
- NCT04236115
- Acronym / sponsor ID
- Taibah dental College
- Keywords
- Carticaine, dental extraction, injections, prilocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Taibah UniversityUniversity, hospital or other
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 22 Jan 2020 (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.
Ninety-five patients, aged between 16 and 70 years old, were included in this study. Patients were divided into two groups. Group one received Articaine 4% with 1:00.000 Adrenalines. Group two received Prilocaine with 3% Felypressin (0.03 I.U. per ml). Onset time of anaesthesia was objectively evaluated by using electronic pulp testing.
Detailed description
85 patients in this study had successful local anaesthetic followed by extraction within the study duration time (10 minutes). However, there were six patients with failure anaesthesia (5 in prilocaine group and 1 in articaine group). By application Person's Chi-square test (x2), there were no significant differences in the number of the episodes of the anaesthetic success between articaine and prilocaine groups at time intervals (P-value = 0.5). T- test showed there have been no important variations within the mean onset time of anaesthesia for articaine and prilocaine buccal infiltrations (P-value =0.1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- double blinded randomised trial
| Arm | Type | Receives |
|---|---|---|
| Articaine 4% with 1:00.000 Adrenaline | Active comparator | Drug: Articaine 4%, Drug: Adrenalinif the patient was in articaine group, buccal infiltration technique was applied by inserting a short needle at the height of buccal sulcus along the long axis of the subject tooth for extraction. |
| Prilocaine with 3% Felypressin (0.03 I.U. per ml) | Active comparator | Drug: Prilocain 3%, Drug: Felypressinif the patient was in prelocaine group, buccal infiltration technique was applied by inserting a short needle at the height of buccal sulcus along the long axis of the subject tooth for extraction. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients have one or two upper teeth for extraction, subject tooth or its adjacent must be vital, healthy patient or patient with mild systemic diseases (class I or II according to American Society of Anesthesiology).
Key exclusion criteria (1 listed)
- Patients excluded from this study if they have allergy to local anaesthetic agents or need surgical, or multiple teeth extraction.
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 |
|---|---|---|
| Articaine 4%Articaine 4% is dental local anaesthetic agent | Drug | Articaine 4% with 1:00.000 Adrenaline |
| Prilocain 3%prilocaine is dental local anaesthetic agent | Drug | Prilocaine with 3% Felypressin (0.03 I.U. per ml) |
| Adrenalinadrenaline is a vasoconstrictor | Drug | Articaine 4% with 1:00.000 Adrenaline |
| FelypressinFelypressin is a vasoconstrictor | Drug | Prilocaine with 3% Felypressin (0.03 I.U. per ml) |
Primary outcome
Does articaine, rather than prilocaine, increase the success rate of anaesthesia for extraction of maxillary teeth
Time frame: 6 months
to compare the anaesthetic performances of 3% prilocaine (the safest local anaesthetic) with 4 % articaine (the local anaesthetic with fastest onset time of action) when used for maxillary teeth 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 22 Jan 2020.
- Derived from this study: PubMed 32934619Gazal G. Does articaine, rather than prilocaine, increase the success rate of anaesthesia for extraction of maxillary teeth. Saudi J Anaesth. 2020 Jul-Sep;14(3):297-301. doi: 10.4103/sja.SJA_94_20. Epub 2020 May 30.
- Individual participant dataSharing planned: Yes. it will be provided on demand
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Articaine 4%, Prilocain 3% and Adrenalin in people with Overcoming the Failure of Anaesthesia and Maxillary Teeth, run by Taibah University at 1 site in Saudi Arabia.
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 22 Jan 2020. 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 Saudi Arabia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Does articaine, rather than prilocaine, increase the success rate of anaesthesia for extraction of maxillary teeth (time frame: 6 months). 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 NCT04236115, which also lists 1 linked publication.
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 22 Jan 2020.