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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04534426
Recruitment Status : Completed
First Posted : September 1, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Koray Onur Sanal, Abant Izzet Baysal University

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

Condition or disease Intervention/treatment Phase
Impacted Third Molar Tooth Drug: : Arnica montana Drug: Mucopolysaccharide polysulfate Other: Control group Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Influence of Different Topical Arnica and Mucopolysaccharide Polysulfate on Postoperative Pain, Edema and Trismus After Extraction of Impacted Third Molar
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Postoperative topical arnica montana cream
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
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
Other Name: Arnika Krem

Active Comparator: Postoperative topical mucopolysaccharide polysulfate cream
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
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 Name: Hirudoid Fort Krem 445mg/100g

Control group
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
In Control group, only standard therapy was performed after surgery




Primary Outcome Measures :
  1. Preoperative Pain Intensity [ Time Frame: On the day of surgery preoperatively ]
    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.

  2. Change From Baseline Maximal Interincisal Opening (MIO) on Postoperative Follow Up Visits [ Time Frame: Preoperatively on the day of surgery, postoperative first, third, fifth and tenth days ]
    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. 3. Change From Baseline Facial Measurements for Evaluation of Edema on Postoperative Follow Up Visits [ Time Frame: Preoperatively on the day of surgery, postoperative first, third, fifth and tenth days ]
    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.



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Ages Eligible for Study:   16 Years to 68 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04534426


Locations
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Turkey
Abant Izzet Baysal University
Bolu, Turkey, 14030
Sponsors and Collaborators
Abant Izzet Baysal University
Investigators
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Study Director: Neşet Akay Abant Izzet Baysal University
Publications of Results:
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Responsible Party: Koray Onur Sanal, Assistant Professor, Abant Izzet Baysal University
ClinicalTrials.gov Identifier: NCT04534426    
Other Study ID Numbers: Abant Izzet Baysal University
2018/284 ( Other Identifier: Clinical Researches and Ethics Committee of Bolu Abant Izzet Baysal University )
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data (IPD) related to study protocol and results will be shared during submitting as an article.
Supporting Materials: 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Koray Onur Sanal, Abant Izzet Baysal University:
impacted third molar
oral surgery
edema
trismus
pain
postoperative sequelae
Additional relevant MeSH terms:
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Tooth, Impacted
Trismus
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Tooth Diseases
Stomatognathic Diseases
Spasm
Neuromuscular Manifestations
Nervous System Diseases