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Study to evaluate the effectiveness of a gel based on flower essences to control pain, swelling and difficulty opening the mouth after extracting the lower wisdom teeth

Study on the postoperative efficacy of Oxyflower® gel to control pain, edema and trismus after extraction of mandibular third molars

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-99wfvv
Enrollment
Unknown
Registered
2020-08-24
Start date
2019-10-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Included teeth

Interventions

It will be a split-mouth study, a single group, n = 13.There will be two surgical interventions for each patient, corresponding to a third molar extraction in each hemimandible. Each surgical interven
Drug
Procedure/surgery
E06.892

Sponsors

Universidade Federal dos Vales do Jequitinhonha e Mucuri
Lead Sponsor
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over the age of 18 years; without compromising general health; with indication of extraction of bilateral third mandibular molars, whether included or not, asymptomatic and in the class IIB position, according to the Pell & Gregory classification and which have similar radiographic characteristics.

Exclusion criteria

Exclusion criteria: Patients with a history of hypersensitivity to any of the components of the medications used; classified as ASA III or ASA IV, according to the American Anesthesiology Association; use of anti-inflammatory drugs in the 15 days prior to surgery; submitted to antibiotic therapy in the last 2 months; patients with tuberculosis, leukocytosis, vascular collagen diseases, multiple sclerosis, HIV infection, and other autoimmune diseases; smokers; pregnant and lactating women; with a history of pericoronaritis; patients with cognitive disorders that make it impossible to understand and execute commands; withdrawal of consent.

Design outcomes

Primary

MeasureTime frame
Edema will be assessed using face point measurements. These measurements will be performed with the patient sitting in an upright posture, with the occlusal plane parallel to the floor and with the mouth closed. Using a tape measure, the outer corner of the eye, the tragus, the pogonion (soft tissue), the goniac angle and the buccal commissure will be taken as reference points on the measured side. The distance in millimeters between the points: the outer corner of the eye at the goniac angle, the lower border of the tragus and buccal commissure and the lower border of the tragus to the pogonion (soft tissue). These assessments will be performed preoperatively (baseline) and compared to measurements in the postoperative period (24, 48 and 72 hours and seven days) in order to establish the edema from the surgical procedure.;To evaluate trismus, a ruler will be used to measure the patient's maximum mouth opening. The patient will be instructed to open the mouth and raise his hand when he reaches the maximum mouth opening. The measurement will be performed from the lower right incisor to the upper right incisor using a ruler. These assessments will be performed preoperatively (baseline) and compared to measurements in the postoperative period (24, 48 and 72 hours and seven days). The variation of the baseline measurement with the postoperative measurements will determine the presence and magnitude of the trismus.;An assessment of the level of pain reported by the patient will be performed using the Visual Analogue Scale (VAS) inserted in a pre-defined evaluation form. This evaluation will be performed 24, 48 and 72 hours and seven days after surgery. This scale consists of a 10 cm line, without demarcations and with the value 0 (zero) at the left end and the value 10 (ten) at the right end. The patient will be instructed to draw a vertical line at the point that defined the degree of painful sensitivity after the surgical procedures. The distance from the left end to t

Secondary

MeasureTime frame
The evaluation of the patient's anxiety and depression will be evaluated by the HADS questionnaire, which has fourteen objective questions, each question with four options to mark. The more negative responses the patient points out, the higher the patient's level of anxiety and depression. This questionnaire will be applied in the baseline, after 24.48.72 hours and 7 days.;The quality of life assessment will be carried out using the OHIP-14 questionnaire. This questionnaire has fourteen questions, where the patient must choose a grade for each one. This grade varies from 0 to 4, never (0), rarely (1), sometimes (2), constantly (3) or always (4). The higher the score of the sum of responses, the greater the negative impact on the patient's quality of life. This questionnaire will be applied in the baseline, after 24.48.72 hours and 7 days.

Countries

Brazil

Contacts

Public ContactSaulo Gabriel Falci

Universidade Federal dos Vales do Jequitinhonha e Mucuri

saulofalci@hotmail.com+550383532-6082

Outcome results

None listed

Source: REBEC (via WHO ICTRP)