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

Study Overview
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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

Official Title
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Influence of Different Topical Arnica and Mucopolysaccharide Polysulfate on Postoperative Pain, Edema and Trismus After Extraction of Impacted Third Molar

Conditions
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Impacted Third Molar Tooth

Intervention / Treatment
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* Drug: : Arnica montana
* Drug: Mucopolysaccharide polysulfate
* Other: Control group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Postoperative topical arnica montana cream<br>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. | Drug: : Arnica montana<br>* 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<br>* Other names: Arnika Krem;|
| Active Comparator: Postoperative topical mucopolysaccharide polysulfate cream<br>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. | Drug: Mucopolysaccharide polysulfate<br>* 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<br>* Other names: Hirudoid Fort Krem 445mg/100g;|
| Other: Control group<br>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. | Other: Control group<br>* In Control group, only standard therapy was performed after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Preoperatively on the day of surgery, postoperative first, third, fifth and tenth days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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impacted third molar, oral surgery, edema, trismus, pain, postoperative sequelae