Topical Arnica and Mucopolysaccharide Polysulfate on Postoperative Pain, Edema and Trismus

Abant Izzet Baysal University60 enrolled

Overview

The present study was to evaluate the effect of topical Arnica and MPSP application with respect to visual analogue scale (VAS) scores, maximal interincisal opening (MIO) and edema values after mandibular impacted third molar removal on days 1, 3, 5 and 10 postoperatively. The following null hypotheses of the present research were determined as follows: usage of topical agents would not influence i) VAS scores, ii) MIO values, and iii) edema values on 1st, 3rd, 5th, and 10th days after the mandibular impacted third molar surgery

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Impacted Third Molar Tooth

Interventions

: Arnica montanaDRUG

In Arnica group, patients were given an unlabelled tube containing cream to be applicated topically on skin surface of masseteric and submandibular region, 2 cm in length cream for each 8 hours, starting immediately after surgery and continued for 10 days

Mucopolysaccharide polysulfateDRUG

In Arnica group and MPSP group, patients were given an unlabelled tube containing cream to be applicated topically on skin surface of masseteric and submandibular region, 2 cm in length cream for each 8 hours, starting immediately after surgery and continued for 10 days

Control groupOTHER

In Control group, only standard therapy was performed after surgery

Eligibility

Sex: ALLMin age: 16 YearsMax age: 68 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 16-68 years * American Society of Anesthesiologists (ASA) Class 1 physiological status * Consistent radiological and clinical data * Volunteered to participate in the study * Scale II" surgery difficulty according to Modified Parant Classification for mandibular impacted third molar removal, be free of pericoronitis and infection at operation time Exclusion Criteria: * Being out of age range * Pregnancy or lactation * Analgesic or antibiotic therapy history in last 14 days due to symptoms of related third molar * Smoking cigarette * Any pathology associated with impacted third molar * Active complaints on preoperative examination on the day of surgery * Immunosuppressed or diagnosed with malignancy * Diagnosed chronic diseases such as; Diabetes mellitus (DM), hypertension, cerebrovascular event, psychiatric diseases, coagulopathies * Autoimmune diseases * Patients who could not attend regular follow-up visits * Allergy to the medications prescribed or utilized in study protocol * Inconsistent clinical and radiological data or missed follow-up

Locations (1)

Abant Izzet Baysal University

Bolu, Turkey (Türkiye)

Outcomes

Primary Outcomes

Preoperative Pain Intensity

The patients were assessed using a visual analogue scale (VAS), 10 cm in length, ranging from 0 for "no pain" to 10 for "the worst possible pain". Preoperative VAS value recorded.

Time frame: On the day of surgery preoperatively

Change From Baseline Maximal Interincisal Opening (MIO) on Postoperative Follow Up Visits

All patients' maximal interincisal opening were measured and recorded as the distance between upper and lower central incisors. Preoperative MIO value recorded. The measurements were repeated as described above in the 1st, 3rd, 5th, and 10th days after surgery and recorded.

Time frame: Preoperatively on the day of surgery, postoperative first, third, fifth and tenth days

3. Change From Baseline Facial Measurements for Evaluation of Edema on Postoperative Follow Up Visits

The level of edema was determined by a modification of tape measuring method described by Gabka and Matsumara \[20, 21\]. Three measurements (in mm) (AC, AE and BE) were made between 5 reference points: A) tragus, B) lateral corner of the eye, C) outer corner of the mouth, D) angle of the mandible, and E) soft tissue pogonion. The mean of three preoperative measurements was calculated and recorded. The measurements were repeated as described above in the 1st, 3rd, 5th, and 10th days after surgery.

Time frame: Preoperatively on the day of surgery, postoperative first, third, fifth and tenth days

Data from ClinicalTrials.gov

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