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

Sponsor

Abant Izzet Baysal University (Other)

Overall Status

Completed

CT.gov ID

NCT04534426

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Impacted Third Molar Tooth	Drug: : Arnica montana Drug: Mucopolysaccharide polysulfate Other: Control group	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 1, 2018

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Jan 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: : 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 Other Names: Arnika Krem
Active Comparator: 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.	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 Other Names: Hirudoid Fort Krem 445mg/100g
Other: 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.	Other: Control group In Control group, only standard therapy was performed after surgery

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: : 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

Other Names:

Arnika Krem

Active Comparator: 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.

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

Other Names:

Hirudoid Fort Krem 445mg/100g

Other: 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.

Other: Control group

In Control group, only standard therapy was performed after surgery

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 68 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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