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

Phase 4

Completed

• Conditions: Impacted Third Molar Tooth
• Interventions: Other: Control group; Drug: Mucopolysaccharide polysulfate

• Registration Number: NCT04534426
• Lead Sponsor: Abant Izzet Baysal University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-30
• Status Verified: 2020-08
• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-08-27
• Last Update Submitted: 2020-08-27
• Study First Posted: 2020-09-01
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	In this arm control group consisted of 20 patients who were treated with only standard therapy (amoxicillin/clavulanic acid 500/125 mg twice a day and diclofenac potassium 50 mg twice a day) after mandibular impacted third molar surgery.
Postoperative topical mucopolysaccharide polysulfate cream	Mucopolysaccharide polysulfate	In this arm, Mucopolysaccharide polysulfate group consisted of 20 patients who were treated with topical arnica in addition to standard therapy (amoxicillin/clavulanic acid 500/125 mg twice a day and diclofenac potassium 50 mg twice a day) after mandibular impacted third molar surgery.

Primary Outcome Measures

Name	Time	Method
Change From Baseline Maximal Interincisal Opening (MIO) on Postoperative Follow Up Visits	Preoperatively on the day of surgery, postoperative first, third, fifth and tenth days	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.
3. Change From Baseline Facial Measurements for Evaluation of Edema on Postoperative Follow Up Visits	Preoperatively on the day of surgery, postoperative first, third, fifth and tenth days	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.
Preoperative Pain Intensity	On the day of surgery preoperatively	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.

Trial Locations

Locations (1)

Abant Izzet Baysal University; 🇹🇷 Bolu, Turkey