Clinical trial NCT04534426: Topical Arnica and Mucopolysaccharide Polysulfate on Postoperative Pain, Edema and Trismus
Official title: Influence of Different Topical Arnica and Mucopolysaccharide Polysulfate on Postoperative Pain, Edema and Trismus After Extraction of Impacted Third Molar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impacted Third Molar Tooth
Keywords: impacted third molar
oral surgery
edema
trismus
pain
postoperative sequelae
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 68
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Preoperative Pain Intensity
timeFrame: On the day of surgery preoperatively
measure: Change From Baseline Maximal Interincisal Opening (MIO) on Postoperative Follow Up Visits
timeFrame: Preoperatively on the day of surgery, postoperative first, third, fifth and tenth days
measure: 3. Change From Baseline Facial Measurements for Evaluation of Edema on Postoperative Follow Up Visits
timeFrame: Preoperatively on the day of surgery, postoperative first, third, fifth and tenth days
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
Study officials:
affiliation: Abant Izzet Baysal University
name: Neşet Akay
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.