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| ID | Type | Description | Link |
|---|---|---|---|
| 2018/284 | Other Identifier | Clinical Researches and Ethics Committee of Bolu Abant Izzet Baysal University |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative topical arnica montana cream | Active Comparator | 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. |
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| Postoperative topical mucopolysaccharide polysulfate cream | Active Comparator | 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. |
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| Control group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| : Arnica montana | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| NeÅŸet Akay | Abant Izzet Baysal University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abant Izzet Baysal University | Bolu | 14030 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26910697 | Result | 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. | |
| 7613277 | Result |
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All individual participant data (IPD) related to study protocol and results will be shared during submitting as an article.
The present study will be transformed to an article in six months
All IPD and supporting information data will be accessible after publication of the article
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| ID | Term |
|---|---|
| D004487 | Edema |
| D014313 | Trismus |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| C000712347 | Arnicae flos extract |
| C052717 | mucopolysaccharide polysulfate |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Mucopolysaccharide polysulfate | Drug | 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 |
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| Control group | Other | In Control group, only standard therapy was performed after surgery |
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| 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. |
| 2469747 | Result | 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. |
| 37913818 | Derived | Akay N, Sanal KO. Can Topical Agents (Arnica and Mucopolysaccharide Polysulfate) Reduce Postoperative Pain, Edema and Trismus Following Mandibular Third Molar Surgery? J Oral Maxillofac Surg. 2024 Jan;82(1):113-121. doi: 10.1016/j.joms.2023.10.003. Epub 2023 Oct 12. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D008722 | Methods |