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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04534426
Enrollment
60
Registered
2020-09-01
Start date
2018-12-01
Completion date
2020-01-30
Last updated
2020-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impacted Third Molar Tooth

Keywords

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

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

Interventions

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

DRUGMucopolysaccharide 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

OTHERControl group

In Control group, only standard therapy was performed after surgery

Sponsors

Abant Izzet Baysal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 68 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Preoperative Pain IntensityOn the day of surgery preoperativelyThe 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 VisitsPreoperatively on the day of surgery, postoperative first, third, fifth and tenth daysAll 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 VisitsPreoperatively on the day of surgery, postoperative first, third, fifth and tenth daysThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026