Impacted Third Molar ToothPhase 4NCT02457325
Lower Third Molar Removal With 2% and 4% Articaine
A Phase 4 study testing Surgery with 2%Articaine first, then Surgery with 4% Articaine and Surgery with 4%Articaine first, then Surgery with 2% Articaine in people with Impacted Third Molar Tooth and Adverse Reaction to Other Local Anesthetics, run by University of Sao Paulo.
Trial summary
The present clinical trial randomized compared the clinical efficacy of the local anesthetics articaine in two concentrations, 2% and 4%, in association with 1:200,000 adrenaline, for the removal of lower third molars. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth, Adverse Reaction to Other Local Anesthetics
- What is being tested?
- Surgery with 2%Articaine first, then Surgery with 4% Articaine and Surgery with 4%Articaine first, then Surgery with 2% Articaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Dec 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Need of lower third molar surgeries in similar positions
Who cannot join
- Presence of systemic diseases;
- Presence of local inflammation and/or infection;
- Any history of allergic reaction to local anesthetics, gastrointestinal bleeding or ulceration;
- Cardiovascular and kidney diseases;
- Asthma and allergy to aspirin, piroxicam or any other non-steroidal antiinflammatory drug;
- Regular use of any non-steroidal antiinflammatory drug, pregnancy or breast feeding.
About this study
Official title: Comparative Analysis Between 2% and Articaine Articaine 4%, Both With 1: 200,000 Epinephrine: Evaluation of Anesthetics Efficacy, Intraoperative Bleeding and Hemodynamic Parameters in Extraction of Lower Third Molars
The present clinical trial randomized compared the clinical efficacy of the local anesthetics articaine in two concentrations, 2% and 4%, in association with 1:200,000 adrenaline, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower third molars, in two separate appointments (one to two months apart), under local anesthesia with either articaine 2% or 4% (both with 1:200,000 adrenaline) in a double-blind, randomized and crossed manner.
Read the detailed description
The present clinical trial randomized compared the clinical efficacy of the local anesthetics articaine in two concentrations, 2% and 4%, in association with 1:200,000 adrenaline, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. This study evaluated the clinical efficacy of two concentrations (2% and 4%) of the local anesthetic articaine, a local anesthetic of moderate duration, associated with adrenalin at 1: 200,000 in 50 patients aged less than 18 years and in need of extraction of the two third molars with similar positions. Evaluated the following parameters: 1) onset of action of the anesthetic agent, 2) the total amount of anesthesia used during surgery, 3) onset and duration of surgery after the administration of the local anesthetic, 4) the incidence, type and severity of adverse reactions, 5) postoperative control of mouth opening, 6) subjective evaluation of postoperative pain, 7) postoperative duration of anesthesia, 8) Total amount of relief medication and 9) heart rate and systolic and diastolic blood pressure before during and after surgery. The comparative analysis of the data and the application of proper statistical tests provided the basis for an assessment of the efficiency of both concentrations of the local anesthetic articaine (2% and 4%) with adrenalin at 1: 200,000.
- Being tested
- Surgery with 2%Articaine first, then Surgery with 4% Articaine, Surgery with 4%Articaine first, then Surgery with 2% Articaine
- Keywords
- Articaine, Lower third molar, Oral Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with 2%Articaine first, then Surgery with 4% ArticaineDrug
Also called Lower third molar with 2% Articaine and 4% Articaine
First Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
Surgery with 4%Articaine first, then Surgery with 2% ArticaineDrug
Also called Lower third molar with 4% Articaine and 2% Articaine
First Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)
| Study group | Role | What they receive |
|---|---|---|
| Surgery With 2% Articaine first, then Surgery With 4%Articaine | Experimental | First Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne) Receives: Drug: Surgery with 2%Articaine first, then Surgery with 4% Articaine |
| Surgery With 4%Articaine first, then Surgery With 2% Articaine | Experimental | First Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne) Receives: Drug: Surgery with 4%Articaine first, then Surgery with 2% Articaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of Anesthetic
Onset of anesthetic agent action, as determined by the loss of sensibility of the inferior lip, the corresponding half of the tongue, and the mucosa as reported by the patient.
Measured: During the surgical procedure, an average of 30 minutes
Quality of Anesthesia
Quality of anesthesia during surgery based on a category 3-point scale: 1) the patient reported no discomfort; 2) the patient reported discomfort, without the need to supplement the anesthesia; 3) reported some discomfort by the patient, requiring anesthesia complementation. Intraoral bleeding that will be evaluated by the surgeon according to a 3-point scale (1: minimal, 2: normal and 3: Maximum), immediately after the following steps: injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing.
Measured: During the surgical procedure, an average of 30 minutes
Intraoperative Bleeding
Intraoperative bleeding, rated by the surgeon according to a 3-point category rating scale (1-minimal bleeding; 2-normal bleeding; 3-excessive bleeding) (SISK, 1986), immediately after the following steps: injection of the first cartridge of articaine, tissue incision, flap reflection, bone removal (when this procedure was necessary), tooth extraction, cleaning of the operated site, and completion of suturing.
Measured: During the surgical procedure, an average of 30 minutes
Blood Pressure
mean blood pressure was verified and recorded at surgical moments previously described (injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing), carried out with the aid of a system for monitoring hemodynamic parameters.
Measured: During the surgical procedure, an average of 30 minutes
Heart Rate
Heart rate to be verified and recorded surgical at moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.
Measured: During the surgical procedure, an average of 30 minutes
Oxygen Saturation
Oxygen saturation to be verified and recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.
Measured: During the surgical procedure, an average of 30 minutes
Secondary outcomes (5)
Duration of Post-operative Analgesia
Duration of post-operative analgesia (in minutes) provided by the local anesthetic will be determined by the difference between the end time of the completion of suture and the one for the first intake piroxicam capsule for the relief of discomfort after surgery, the patient noted in token that you will be provided. Duration of post-surgical anesthesia (in minutes) on the soft tissues provided by local anesthetic, represented by the lack of sensitivity in the mucosa, tongue and lower lip after the surgery. The patient will note the time at which this phenomenon happens on the card which will be provided.
Measured: During the day of the surgery, 24 hours
Postoperative Mouth Opening
Mouth opening (mm) between the mesial-incisal corners of the upper and lower right central incisors at maximum opening of the jaws was measured and recorded. Results presented below represent those assessed on the seventh postoperative day.
Measured: Seventh postoperative days
Wound Healing of the Operated Area
Quality of wound healing of the operated area classified by the surgeon according to a scale of three types of points: 1-normal healing, 2-delayed healing, 3-wound healing complicated by the presence of alveolitis at the time of removal of the suture (7th postoperative day).
Measured: Seventh postoperative day
Evaluation of Post-surgical Pain
Subjective evaluation of post-surgical pain, which was annotated by the volunteer, a Visual Analogue Scale (VAS, 0-100 mm - higher values represent a worse outcome) in the postoperative period.
Measured: Seventh postoperative day
Postoperative Anesthesia
Duration of postoperative anesthesia, represented by the lack of sensibility of the mucosa, tongue, and inferior lip.
Measured: During the day of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startJun 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Carlos Ferreira dos Santos, University of Sao Paulo
- Investigators
- Carlos F Santos, PhD, Principal investigator, Bauru School of Dentistry/University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457325
- Sponsor's protocol ID
- U1111-1120-3074
- Status last verified
- Oct 2020
- First submitted
- 18 May 2015
- Last updated
- 24 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data are presented as mean and standard deviation
Publications
Senes AM, Calvo AM, Colombini-Ishikiriama BL, Goncalves PZ, Dionisio TJ, Sant'ana E, Brozoski DT, Lauris JR, Faria FA, Santos CF. Efficacy and Safety of 2% and 4% Articaine for Lower Third Molar Surgery. J Dent Res. 2015 Sep;94(9 Suppl):166S-73S. doi: 10.1177/0022034515596313. Epub 2015 Jul 22.
PubMed 26202994
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis Between 2% and Articaine Articaine 4%, Both With 1: 200,000 Epinephrine: Evaluation of Anesthetics Efficacy, Intraoperative Bleeding and Hemodynamic Parameters in Extraction of Lower Third Molars
- ClinicalTrials.gov ID
- NCT02457325
- Acronym / sponsor ID
- U1111-1120-3074
- Keywords
- Articaine, Lower third molar, Oral Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Posted 24 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present clinical trial randomized compared the clinical efficacy of the local anesthetics articaine in two concentrations, 2% and 4%, in association with 1:200,000 adrenaline, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower third molars, in two separate appointments (one to two months apart), under local anesthesia with either articaine 2% or 4% (both with 1:200,000 adrenaline) in a double-blind, randomized and crossed manner.
Detailed description
The present clinical trial randomized compared the clinical efficacy of the local anesthetics articaine in two concentrations, 2% and 4%, in association with 1:200,000 adrenaline, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. This study evaluated the clinical efficacy of two concentrations (2% and 4%) of the local anesthetic articaine, a local anesthetic of moderate duration, associated with adrenalin at 1: 200,000 in 50 patients aged less than 18 years and in need of extraction of the two third molars with similar positions. Evaluated the following parameters: 1) onset of action of the anesthetic agent, 2) the total amount of anesthesia used during surgery, 3) onset and duration of surgery after the administration of the local anesthetic, 4) the incidence, type and severity of adverse reactions, 5) postoperative control of mouth opening, 6) subjective evaluation of postoperative pain, 7) postoperative duration of anesthesia, 8) Total amount of relief medication and 9) heart rate and systolic and diastolic blood pressure before during and after surgery. The comparative analysis of the data and the application of proper statistical tests provided the basis for an assessment of the efficiency of both concentrations of the local anesthetic articaine (2% and 4%) with adrenalin at 1: 200,000.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery With 2% Articaine first, then Surgery With 4%Articaine | Experimental | Drug: Surgery with 2%Articaine first, then Surgery with 4% ArticaineFirst Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne) |
| Surgery With 4%Articaine first, then Surgery With 2% Articaine | Experimental | Drug: Surgery with 4%Articaine first, then Surgery with 2% ArticaineFirst Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Need of lower third molar surgeries in similar positions
Key exclusion criteria (6 listed)
- Presence of systemic diseases;
- Presence of local inflammation and/or infection;
- Any history of allergic reaction to local anesthetics, gastrointestinal bleeding or ulceration;
- Cardiovascular and kidney diseases;
- Asthma and allergy to aspirin, piroxicam or any other non-steroidal antiinflammatory drug;
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 |
|---|---|---|
| Surgery with 2%Articaine first, then Surgery with 4% ArticaineAlso: Lower third molar with 2% Articaine and 4% ArticaineFirst Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne) | Drug | Surgery With 2% Articaine first, then Surgery With 4%Articaine |
| Surgery with 4%Articaine first, then Surgery with 2% ArticaineAlso: Lower third molar with 4% Articaine and 2% ArticaineFirst Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne) | Drug | Surgery With 4%Articaine first, then Surgery With 2% Articaine |
Primary outcome
Onset of Anesthetic
Time frame: During the surgical procedure, an average of 30 minutes
Onset of anesthetic agent action, as determined by the loss of sensibility of the inferior lip, the corresponding half of the tongue, and the mucosa as reported by the patient.
Quality of Anesthesia
Time frame: During the surgical procedure, an average of 30 minutes
Quality of anesthesia during surgery based on a category 3-point scale: 1) the patient reported no discomfort; 2) the patient reported discomfort, without the need to supplement the anesthesia; 3) reported some discomfort by the patient, requiring anesthesia complementation. Intraoral bleeding that will be evaluated by the surgeon according to a 3-point scale (1: minimal, 2: normal and 3: Maximum), immediately after the following steps: injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing.
Intraoperative Bleeding
Time frame: During the surgical procedure, an average of 30 minutes
Intraoperative bleeding, rated by the surgeon according to a 3-point category rating scale (1-minimal bleeding; 2-normal bleeding; 3-excessive bleeding) (SISK, 1986), immediately after the following steps: injection of the first cartridge of articaine, tissue incision, flap reflection, bone removal (when this procedure was necessary), tooth extraction, cleaning of the operated site, and completion of suturing.
Blood Pressure
Time frame: During the surgical procedure, an average of 30 minutes
mean blood pressure was verified and recorded at surgical moments previously described (injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing), carried out with the aid of a system for monitoring hemodynamic parameters.
Heart Rate
Time frame: During the surgical procedure, an average of 30 minutes
Heart rate to be verified and recorded surgical at moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.
Oxygen Saturation
Time frame: During the surgical procedure, an average of 30 minutes
Oxygen saturation to be verified and recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.
5 secondary outcomes
Duration of Post-operative Analgesia
Time frame: During the day of the surgery, 24 hours
Postoperative Mouth Opening
Time frame: Seventh postoperative days
Wound Healing of the Operated Area
Time frame: Seventh postoperative day
Evaluation of Post-surgical Pain
Time frame: Seventh postoperative day
Postoperative Anesthesia
Time frame: During the day of the surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26202994Senes AM, Calvo AM, Colombini-Ishikiriama BL, Goncalves PZ, Dionisio TJ, Sant'ana E, Brozoski DT, Lauris JR, Faria FA, Santos CF. Efficacy and Safety of 2% and 4% Articaine for Lower Third Molar Surgery. J Dent Res. 2015 Sep;94(9 Suppl):166S-73S. doi: 10.1177/0022034515596313. Epub 2015 Jul 22.
- Individual participant dataSharing planned: No. Data are presented as mean and standard deviation
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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.
Carlos F Santos, PhD principal investigator
Bauru School of Dentistry/University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surgery with 2%Articaine first, then Surgery with 4% Articaine and Surgery with 4%Articaine first, then Surgery with 2% Articaine in people with Impacted Third Molar Tooth and Adverse Reaction to Other Local Anesthetics, run by University of Sao Paulo.
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 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 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 24 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Onset of Anesthetic (time frame: During the surgical procedure, an average of 30 minutes). The study lists 6 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 NCT02457325, 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 24 Nov 2020.