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NCT Number: NCT04534426

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

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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Key information

Conditions

Impacted Third Molar Tooth Edema Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Trismus

Age range

16 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Abant Izzet Baysal University

Bolu, 14030, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

: Arnica montana

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

Other names: Arnika Krem

Mucopolysaccharide polysulfate

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

Other names: Hirudoid Fort Krem 445mg/100g

Control Group

Other

In Control group, only standard therapy was performed after surgery

Primary outcomes

  1. Preoperative Pain Intensity

    Time frame: 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.

  2. Change From Baseline Maximal Interincisal Opening (MIO) on Postoperative Follow Up Visits

    Time frame: 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. 3. Change From Baseline Facial Measurements for Evaluation of Edema on Postoperative Follow Up Visits

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 1, 2020
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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