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

Abant Izzet Baysal University

Status and phase: Completed; Phase 4

Conditions: Impacted Third Molar Tooth

Treatments: Drug: Mucopolysaccharide polysulfate; Drug: : Arnica montana; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT04534426

2018/284 (Other Identifier)

Abant Izzet Baysal University

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 16 to 68 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Postoperative topical arnica montana cream

Active Comparator group

Description:

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.

Treatment:

Drug: : Arnica montana

Postoperative topical mucopolysaccharide polysulfate cream

Active Comparator group

Description:

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.

Treatment:

Drug: Mucopolysaccharide polysulfate

Control group

Other group

Description:

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.

Treatment:

Other: Control group