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

Primary Purpose

Impacted Third Molar Tooth

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
: Arnica montana
Mucopolysaccharide polysulfate
Control group
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Impacted Third Molar Tooth focused on measuring impacted third molar, oral surgery, edema, trismus, pain, postoperative sequelae

Eligibility Criteria

16 Years - 68 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Abant Izzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Postoperative topical arnica montana cream

Postoperative topical mucopolysaccharide polysulfate cream

Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 27, 2020
Last Updated
August 27, 2020
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT04534426
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
impacted third molar, oral surgery, edema, trismus, pain, postoperative sequelae

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Postoperative topical arnica montana cream
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Postoperative topical mucopolysaccharide polysulfate cream
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
: Arnica montana
Other Intervention Name(s)
Arnika Krem
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Mucopolysaccharide polysulfate
Other Intervention Name(s)
Hirudoid Fort Krem 445mg/100g
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
In Control group, only standard therapy was performed after surgery
Primary Outcome Measure Information:
Title
Preoperative Pain Intensity
Description
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.
Time Frame
On the day of surgery preoperatively
Title
Change From Baseline Maximal Interincisal Opening (MIO) on Postoperative Follow Up Visits
Description
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.
Time Frame
Preoperatively on the day of surgery, postoperative first, third, fifth and tenth days
Title
3. Change From Baseline Facial Measurements for Evaluation of Edema on Postoperative Follow Up Visits
Description
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.
Time Frame
Preoperatively on the day of surgery, postoperative first, third, fifth and tenth days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neşet Akay
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Study Director
Facility Information:
Facility Name
Abant Izzet Baysal University
City
Bolu
ZIP/Postal Code
14030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All individual participant data (IPD) related to study protocol and results will be shared during submitting as an article.
IPD Sharing Time Frame
The present study will be transformed to an article in six months
IPD Sharing Access Criteria
All IPD and supporting information data will be accessible after publication of the article
Citations:
PubMed Identifier
26910697
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.
Results Reference
result
PubMed Identifier
7613277
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.
Results Reference
result
PubMed Identifier
2469747
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.
Results Reference
result

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

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