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

Impacted Third Molar Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04534426
• Other study ID #: Abant Izzet Baysal University
• Secondary ID: 2018/284
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: August 2020
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Pain, Postoperative
• Tooth, Impacted
• Trismus

Intervention

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
• Mucopolysaccharide 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

Other:
• Control group
In Control group, only standard therapy was performed after surgery

Locations

Country	Name	City	State
Turkey	Abant Izzet Baysal University	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Lökken 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. — View 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-5 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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