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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery with 2%Articaine first, then Surgery with 4% Articaine | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | During the surgical procedure, an average of 30 minutes |
| Heart Rate |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos F Santos, PhD | Bauru School of Dentistry/University of Sao Paulo | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26202994 | Derived | 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. |
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Data are presented as mean and standard deviation
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46 of 50 patients were randomized. Of those not randomized, 4 did not return to folow up and were excluded of the study.
50 patients were recruited to perform bilateral surgery for extraction of lower third molars, at the Faculty of Dentistry of Bauru
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgery With 2% Articaine First, Then 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) |
| FG001 | Surgery With 4%Articaine First, Then 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
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| ||||||||||||||||||
| Washout (1-2 Months) |
| |||||||||||||||||||
| Second Intervention (1 Day) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgery With 2%Articaine First, Then Surgery With 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | minutes | During the surgical procedure, an average of 30 minutes |
|
1 month after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgery With 2%Articaine | Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| paresthesia of the lingual nerve | Injury, poisoning and procedural complications | paresthesia lingual | Non-systematic Assessment | Temporary paresthesia of lingual nerve (3 months) on both sides of surgeries. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlos Ferreira Santos | University of Sao Paulo / Bauru School of Dentistry | +551432358200 | cfsantos@fob.usp.br |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D002355 | Carticaine |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
|
| Surgery with 4%Articaine first, then Surgery with 2% Articaine | Drug | 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) |
|
|
Heart rate to be verified and recorded surgical at moments described above, carried out with the aid of a system for monitoring hemodynamic parameters. |
| 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. | During the surgical procedure, an average of 30 minutes |
| 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. | 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). | 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. | Seventh postoperative day |
| Postoperative Anesthesia | Duration of postoperative anesthesia, represented by the lack of sensibility of the mucosa, tongue, and inferior lip. | During the day of the surgery |
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| NOT COMPLETED |
|
| Surgery With 4%Articaine First, Then Surgery With 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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | During the surgical procedure, an average of 30 minutes |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | During the surgical procedure, an average of 30 minutes |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mmHg | During the surgical procedure, an average of 30 minutes |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | bpm | During the surgical procedure, an average of 30 minutes |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of oxigen in blood | During the surgical procedure, an average of 30 minutes |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | minutes | During the day of the surgery, 24 hours |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | Seventh postoperative days |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | Seventh postoperative day |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Seventh postoperative day |
|
|
|
|
| Secondary | Postoperative Anesthesia | Duration of postoperative anesthesia, represented by the lack of sensibility of the mucosa, tongue, and inferior lip. | Posted | Mean | Standard Deviation | minutes | During the day of the surgery |
|
|
|
|
| 0 |
| 46 |
| 1 |
| 46 |
| EG001 | Surgery With 4%Articaine | Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne) | 0 | 46 | 1 | 46 |
|
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| D006571 |
| Heterocyclic Compounds |