SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03169127

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Clinical Pharmacogenetic of Ibuprofen Enantiomers After Lower Third Molar Surgeries

The present clinical trial randomized will be to assess the link between the different haplotypes of CYP2C8 and CYP2C9 genes and the clinical efficacy of ibuprofen after lower third molar extractions. 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, 200 healthy volunteers underwent removal of one lower third molar, under local anesthesia with articaine 4% (1:200,000 adrenaline) will be genotyped and phenotyped for these genes and their postoperative records with all data collected will be compared with the haplotypes found in the Brazilian population.

NCT03169127 Pain Other Surgical Procedures Impacted Third Molar Tooth
MeSH:Tooth, Impacted
HPO:Impacted tooth

1 Interventions

Name: Ibuprofen 600 mg

Description: After lower third molars surgeries, pharmacogenetic and clinical efficacy of Ibuprofen 600mg was study.
Type: Drug
Group Labels: 1

Experimental Group Ibuprofen 600mg


Primary Outcomes

Description: Subjective evaluation of postsurgical pain, which was annotated by the volunteer after the surgery, in a Visual Analogue Scale (VAS, 0-100 mm). The subjective pain evaluations will be performed by patients at the following times after administration of the drug [0, 15, 30 and 45 min, 1; 1.5; 2; 3; 4; 5; 6; 7; 8; 10; 12; 16; 24 hr, 48, 72 and 96 h]. What will be taken into account on this outcome is the representation of the postsurgical pain, that will be noted on the Visual Analogue Scale (in millimeters) in respective moments.

Measure: Evaluation of changes in the postsurgical pain during the first 24 hours until 96 hours after the procedure

Time: Seventh postoperative day

Description: Quality of anesthesia during surgery based on a category 3point 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 3point 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.

Measure: Quality of anesthesia

Time: During the surgical procedure

Description: 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.

Measure: Intraoperative bleeding during the surgeries steps

Time: During the surgical procedure

Description: Systolic blood pressure, diastolic, and mean to be 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.

Measure: Blood pressure variability during the surgeries steps

Time: During the surgical procedure

Description: Heart rate to be verified and recorded surgical at moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.

Measure: Heart rate variability during the surgeries steps

Time: During the surgical procedure

Description: Oxygen saturation to be verified and recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.

Measure: Oxygen saturation variability during the surgeries steps

Time: During the surgical procedure

Description: Subjective evaluation of postsurgical pain at the moment of the rescue medication consumption which was annotated by the volunteer after the surgery, in a Visual Analogue Scale (VAS, 0-100 mm).

Measure: Subjective evaluation of postsurgical pain at the moment of the rescue medication utilization

Time: Seventh postoperative day

Secondary Outcomes

Description: 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 before the surgery and during the second and seventh postoperative days.

Measure: Postoperative mouth opening

Time: Second and Seventh postoperative days

Description: Will only be considered those surgeries in which there is no difference in the duration time of the procedure between the patients. This time count will be started after the administration of the first local anesthetic. Unit of mesure used will be hours.

Measure: Onset and duration of surgery after administration of local anesthetic

Time: During the surgery

Description: Will be considered as adverse reactions: gastrointestinal irritation, nausea, vomiting, bleeding, allergy, headache, dizziness, drowsiness or any other type of reaction presented after surgery.

Measure: Incidence, type and severity of adverse reactions after the surgery

Time: Seventh postoperative day

Description: The total amount of rescue medication that was used by the patient during the postoperative period (Acetominophen- 750 mg) will be analyzed.

Measure: Total amount of rescue medication

Time: Seventh postoperative day

Description: It will apply the method used by Ustun et al. (2003), which takes into account the sum of the following measures (obtained with flexible tape measure): A) distance between the lateral corner of the eye and the gonion, B) away from the tragus corner of the mouth and C) away from the tragus to the soft tissue of pogonion. Preoperative sum of three measures will be considered as the baseline that way. The difference between the values obtained in the postoperative period and baseline indicate the facial edema in the 2nd and 7th days.

Measure: Measurement the facial edema

Time: On the second day after surgery and on the seventh day after surgery.

Purpose: Supportive Care

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 A118G

We will evaluate also the relationship between the different haplotypes of OPRM1 gene (SNP A118G), the salivary concentrations of pro-inflammatory cytokines (IL-2, IL-4, IL-6, IL-10 and TNF-±), and preoperative conditioned pain modulation. --- A118G ---



HPO Nodes


HPO: