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

NCT04534426 | Completed Phase 4

• 2 other identifiers: Abant Izzet Baysal University2018/284
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Impacted Third Molar Tooth

Keywords

impacted third molar; oral surgery; edema; trismus; pain; postoperative sequelae

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Postoperative topical arnica montana cream

ACTIVE COMPARATOR

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

Postoperative topical mucopolysaccharide polysulfate cream

ACTIVE COMPARATOR

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

Control group

OTHER

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

Interventions

: 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

Also known as: Arnika Krem

Postoperative topical arnica montana cream

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

Also known as: Hirudoid Fort Krem 445mg/100g

Postoperative topical mucopolysaccharide polysulfate cream

Control group OTHER

In Control group, only standard therapy was performed after surgery

Control group

Eligibility Criteria

• Age: 16 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University

Bolu, 14030, Turkey (Türkiye)

Location

Related Publications (4)

• Simsek G, Sari E, Kilic R, Bayar Muluk N. Topical Application of Arnica and Mucopolysaccharide Polysulfate Attenuates Periorbital Edema and Ecchymosis in Open Rhinoplasty: A Randomized Controlled Clinical Study. Plast Reconstr Surg. 2016 Mar;137(3):530e-535e. doi: 10.1097/01.prs.0000479967.94459.1c.

  PMID: 26910697 RESULT

• Lokken P, Straumsheim PA, Tveiten D, Skjelbred P, Borchgrevink CF. Effect of homoeopathy on pain and other events after acute trauma: placebo controlled trial with bilateral oral surgery. BMJ. 1995 Jun 3;310(6992):1439-42. doi: 10.1136/bmj.310.6992.1439.

  PMID: 7613277 RESULT

• Sindet-Pedersen S, Lund E, Simonsen EK, Stenbjerg S. The anti-inflammatory effect of organo-heparinoid cream after bilateral mandibular osteotomies. Int J Oral Maxillofac Surg. 1989 Feb;18(1):35-8. doi: 10.1016/s0901-5027(89)80013-x.

  PMID: 2469747 RESULT

• Akay N, Sanal KO. Can Topical Agents (Arnica and Mucopolysaccharide Polysulfate) Reduce Postoperative Pain, Edema and Trismus Following Mandibular Third Molar Surgery? J Oral Maxillofac Surg. 2024 Jan;82(1):113-121. doi: 10.1016/j.joms.2023.10.003. Epub 2023 Oct 12.

  PMID: 37913818 DERIVED

MeSH Terms

Conditions

Edema; Trismus; Pain

Interventions

Arnicae flos extract; mucopolysaccharide polysulfate; Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Neşet Akay

  Abant Izzet Baysal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 1, 2020
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: January 30, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The present study will be transformed to an article in six months
• Access Criteria: All IPD and supporting information data will be accessible after publication of the article

Locations

TU (1)