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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-01-30

Brief Summary

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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

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Detailed Description

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Conditions

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Impacted Third Molar Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Postoperative topical arnica montana cream

In this arm, Arnica 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.

Group Type ACTIVE_COMPARATOR

: Arnica montana

Intervention Type DRUG

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

Postoperative topical mucopolysaccharide polysulfate cream

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.

Group Type ACTIVE_COMPARATOR

Mucopolysaccharide polysulfate

Intervention Type DRUG

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 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.

Group Type OTHER

Control group

Intervention Type OTHER

In Control group, only standard therapy was performed after surgery

Interventions

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: Arnica montana

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

Intervention Type DRUG

Mucopolysaccharide polysulfate

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

Intervention Type DRUG

Control group

In Control group, only standard therapy was performed after surgery

Intervention Type OTHER

Other Intervention Names

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Arnika Krem Hirudoid Fort Krem 445mg/100g

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes