Impacted Third Molar ToothPhase 4NCT04534426
Topical Arnica and Mucopolysaccharide Polysulfate on Postoperative Pain, Edema and Trismus
A Phase 4 study testing : Arnica montana and Mucopolysaccharide polysulfate in people with Impacted Third Molar Tooth, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 16 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- : Arnica montana and Mucopolysaccharide polysulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 30 Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 68 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Different Topical Arnica and Mucopolysaccharide Polysulfate on Postoperative Pain, Edema and Trismus After Extraction of Impacted Third Molar
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
- Conditions
- Impacted Third Molar Tooth
- Being tested
- : Arnica montana, Mucopolysaccharide polysulfate, Control group
- Keywords
- impacted third molar, oral surgery, edema, trismus, pain, postoperative sequelae
- Medical subject headings
- Edema, Trismus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
: Arnica montanaDrug
Also called Arnika Krem
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 polysulfateDrug
Also called Hirudoid Fort Krem 445mg/100g
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
Control groupOther
In Control group, only standard therapy was performed after surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: : Arnica montana |
| 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. Receives: Drug: Mucopolysaccharide polysulfate |
| 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Preoperatively on the day of surgery, postoperative first, third, fifth and tenth days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Dec 2018
- Primary completion1 Dec 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koray Onur Sanal, Abant Izzet Baysal University
- Investigators
- Neşet Akay, Study director, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534426
- Sponsor's protocol ID
- Abant Izzet Baysal University
- Other IDs
- 2018/284
- Status last verified
- Aug 2020
- First submitted
- 27 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) related to study protocol and results will be shared during submitting as an article.
Publications
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.
PubMed 26910697Lokken 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.
PubMed 7613277Sindet-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.
PubMed 2469747Akay 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.
PubMed 37913818
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Topical Arnica and Mucopolysaccharide Polysulfate on Postoperative Pain, Edema and Trismus After Extraction of Impacted Third Molar
- ClinicalTrials.gov ID
- NCT04534426
- Acronym / sponsor ID
- Abant Izzet Baysal University
- Conditions
- Impacted Third Molar Tooth
- Keywords
- impacted third molar, oral surgery, edema, trismus, pain, postoperative sequelae
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Postoperative topical arnica montana cream | Active comparator | Drug: : Arnica montanaIn 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. |
| Postoperative topical mucopolysaccharide polysulfate cream | Active comparator | Drug: Mucopolysaccharide polysulfateIn 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. |
| Control group | Other | Other: Control groupIn 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. |
Who may qualify
- Ages
- 16 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| : Arnica montanaAlso: Arnika KremIn 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 | Drug | Postoperative topical arnica montana cream |
| Mucopolysaccharide polysulfateAlso: Hirudoid Fort Krem 445mg/100gIn 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 | Drug | Postoperative topical mucopolysaccharide polysulfate cream |
| Control groupIn Control group, only standard therapy was performed after surgery | Other | Control group |
Primary outcome
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.
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. 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Results publication: PubMed 26910697Simsek 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 publication: PubMed 7613277Lokken 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 publication: PubMed 2469747Sindet-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.
- Derived from this study: PubMed 37913818Akay 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.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) related to study protocol and results will be shared during submitting as an article.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neşet Akay study director
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing : Arnica montana and Mucopolysaccharide polysulfate in people with Impacted Third Molar Tooth, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Pain Intensity (time frame: On the day of surgery preoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534426, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.