Third Molar SurgeryPhase 4NCT04200885

Is Therapeutic Elastic Bandage As Effective As Corticosteroids Following Third Molar Surgery?

A Phase 4 study testing Dexketoprofen Trometamol, Dexamethasone 21-Phosphate and Therapeutic Elastic Bandage in people with Third Molar Surgery, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Third Molar Surgery
What is being tested?: Dexketoprofen Trometamol, Dexamethasone 21-Phosphate and Therapeutic Elastic Bandage
Type of treatment: Pill or oral medicine, Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 2 May 2019to 21 Nov 2019
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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age between 18-65 years
American Society of Anesthesiologists (ASA) Class 1 physiological status
Consistent radiological and clinical data
Volunteered to participate in the study
Surgical difficulty score above 5 which was determined according to Pederson scale.

Who cannot join

Being out of age range
Analgesic or antibiotic therapy history in last 30 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

Show all 12Show fewer

Diagnosed chronic diseases such as; Diabetes mellitus (DM), hypertension, cerebrovascular event, psychiatric diseases, coagulopathies
Autoimmune diseases
If total operation time exceeds 45 minutes
Patients who could not attend regular follow-up visits
Allergy to the medications prescribed or utilized in study protocol
Inconsistent clinical and radiological data

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Tokat Gaziosmanpasa University, Faculty of Dentistry
Tokat Province, 60100

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison Of The Effectiveness Of Submucosal Corticosteroid Injection And Elastic Therapeutic Bandage Applications On Pain, Swelling And Trismus After Surgical Removal Of Mandibular Third Molar Teeth

In this study; Among the patients randomized because of severe postoperative sequelae expected as a result of radiological and clinical examinations; nonsteroid antiinflammatory drug prescribed group compared with preoperative single dose intraoral submucosal corticosteroid administration and therapeutic elastic bandage application considering inflammatory symptoms' severity and health related quality of life following surgical removal of impacted third molars. The study hypothesis was formed stating that corticosteroid injection and elastic bandage application would reduce the inflammatory symptoms more than NSAID.

Conditions: Third Molar Surgery
Being tested: Dexketoprofen Trometamol, Dexamethasone 21-Phosphate, Therapeutic Elastic Bandage
Keywords: Dexamethasone, Applied Kinesiology, Non-Steroidal Anti-Inflammatory Agents, Teeth, Impacted, Edema, Trismus, Postoperative Pain
Medical subject headings: Tooth, Impacted, Edema, Trismus, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexketoprofen TrometamolDrug
Also called Arveles 25 mg 20 tablets
Patients were instructed to record the number of drugs they used until the second and seventh postoperative days.
Dexamethasone 21-PhosphateDrug
Also called Dekort 8mg/2ml Intramuscular (IM)/ Intravenous (IV)
Injections were administered in the immediate preoperative period as a single shot.
Therapeutic Elastic BandageDevice
Also called Kinesio Tex Gold Fingerprint (FP)
The bands' lengths were individually measured and divided into five equal parts up to 2/3 of their lengths to obtain fan-type shape.

Study groups in NCT04200885
Study group	Role	What they receive
Postoperative NSAID Prescription	Active comparator	Patients in this arm received common postoperative prescriptions following removal of their impacted third molars for seven days; twice a day 500 mg amoxicillin+125 mg clavulanic acid, twice a day 25 mg dexketoprofen trometamol and three times a day 1.5 mg/ml clorhexidine gluconate+1.2 mg/ml benzydamine hydrochloride containing 200 ml mouthwash. Receives: Drug: Dexketoprofen Trometamol
Preoperative Submucosal Corticosteroid Injection	Active comparator	Patients in this arm were administered 8mg/2ml dexamethasone 21-phosphate preoperatively after local anesthesia were obtained. Injection site was the depth of buccal sulcus near operation site. For the patients in this arm 25 mg dexketoprofen trometamol was excluded from postoperative prescription in order not to affect the anti-inflammatory effects of corticosteroid. Instead of NSAID, three times a day 500 mg paracetamol was prescribed. The patients were advised not to exceed maximal dosage of 3000 mg (6 tablets) in a day. Receives: Drug: Dexamethasone 21-Phosphate
Postoperative Therapeutic Elastic Bandage Application	Active comparator	In this arm the therapeutic elastic bandage applications were immediately performed after removal of mandibular third molars. The distance between tragus-lateral commissura line and supraclavicular lymph nodes was measured and the tapes were then cut into 5 tails. The base of the tape was placed on supraclavicular lymph nodes and tails were placed on the site to cover parotid, submandibular, submental and superficial cervical lymph nodes. The tapes were removed on postoperative second day. Receives: Device: Therapeutic Elastic Bandage

What is being measured

The primary outcome is the main question the study is designed to answer.

Preoperative Pain Intensity
The patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain on the day of surgery preoperatively.
Measured: On the day of surgery preoperatively
Change From Baseline Maximal Mouth Opening on Postoperative Follow Up Visits
All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.
Measured: Preoperatively on the day of surgery, postoperative second and seventh days.
Change From Baseline Facial Measurements on Postoperative Follow Up Visits
Measurements were performed on the ipsilateral site between tragus and lateral commissura, lateral canthus and angle of mandible with a flexible ruler. The obtained values' average amounts were calculated and recorded for each patient.
Measured: Preoperatively on the day of surgery, postoperative second and seventh days.
Oral Analgesic Consumption-1
The patients were asked to record the amounts of consumed analgesic tablets (tablets per day) until first follow up visit.
Measured: Postoperative Second Day
Postoperative Pain Intensity-1
The patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain.
Measured: Postoperative Second Day
Postoperative Pain Intensity-2
The patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain.
Measured: Postoperative Seventh Day
Oral Analgesic Consumption-2
The patients were asked to record the amounts of consumed analgesic tablets (tablets per day) between first and last follow up visits.
Measured: Postoperative Seventh Day

Secondary outcomes (3)

Wound Healing Scores
Extraction wound healing rates were evaluated by Landry's healing index. The index scores were classified as; 1. Very poor, 2. Poor, 3. Good, 4. Very Good and 5. Excellent.
Measured: Postoperative second and seventh days.
Oral Health Impact Profile
Oral health-related quality of life was followed up with Oral Health Impaction Profile-14 questionnaire (Turkish Version). The investigators aimed to detect the alterations in quality of life due to surgical intervention and the other treatment modalities. The obtainable scores vary between 0-56 points. Lower scores indicate better postoperative physical and psychological conditions.
Measured: Preoperatively on the day of surgery, postoperative second and seventh days.
Postoperative Symptom Severity Evaluation
Postoperative inflammatory symptoms were evaluated with the postoperative symptom severity scale at the end of the follow-up period individually. The scale scores vary between 0%-100%. The higher scores indicate that the individual experienced severe symptoms. The investigators aimed to detect the severity of symptoms from the point of the patient's view.
Measured: Postoperative seventh day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 May 201921 Nov 2019

First posted16 Dec 2019
Study start2 May 2019
Primary completion26 Aug 2019
Study completion21 Nov 2019

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 Third Molar SurgeryStudies of the same condition, open and under way.
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
Model description: Among the patients randomized because of severe postoperative sequelae expected as a result of radiological examination prior to surgical extraction of lower third molar teeth; postoperatively nonsteroid antiinflammatory drug prescribed group compared with preoperative single dose intraoral submucosal corticosteroid administration and postoperative therapeutic elastic bandage application.
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04200885
Sponsor's protocol ID: 19-KAEK-100
Status last verified: Dec 2019
First submitted: 8 Dec 2019
Last updated: 17 Dec 2019
Results posted: No
Data monitoring committee: 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

Ristow O, Hohlweg-Majert B, Sturzenbaum SR, Kehl V, Koerdt S, Hahnefeld L, Pautke C. Therapeutic elastic tape reduces morbidity after wisdom teeth removal--a clinical trial. Clin Oral Investig. 2014 May;18(4):1205-1212. doi: 10.1007/s00784-013-1067-3. Epub 2013 Aug 21.
PubMed 23963616
Alcantara CE, Falci SG, Oliveira-Ferreira F, Santos CR, Pinheiro ML. Pre-emptive effect of dexamethasone and methylprednisolone on pain, swelling, and trismus after third molar surgery: a split-mouth randomized triple-blind clinical trial. Int J Oral Maxillofac Surg. 2014 Jan;43(1):93-8. doi: 10.1016/j.ijom.2013.05.016. Epub 2013 Jun 28.
PubMed 23810681
Deo SP. Single-Dose of Submucosal Injection of Dexamethasone Affects the Post Operative Quality of Life After Third Molar Surgery. J Maxillofac Oral Surg. 2016 Sep;15(3):367-375. doi: 10.1007/s12663-015-0846-6. Epub 2015 Dec 7.
PubMed 27752209
Erdil A, Akbulut N, Altan A, Demirsoy MS. Comparison of the effect of therapeutic elastic bandage, submucosal dexamethasone, or dexketoprofen trometamol on inflammatory symptoms and quality of life following third molar surgery: a randomized clinical trial. Clin Oral Investig. 2021 Apr;25(4):1849-1857. doi: 10.1007/s00784-020-03487-y. Epub 2020 Aug 15.
PubMed 32803439

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
Periodontal Defect
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Recruiting
Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery
Dental Anxiety, Postoperative Pain
Not yet recruiting
Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery
Impacted Third Molar Tooth, Surgical Wound Healing

All Third Molar Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison Of The Effectiveness Of Submucosal Corticosteroid Injection And Elastic Therapeutic Bandage Applications On Pain, Swelling And Trismus After Surgical Removal Of Mandibular Third Molar Teeth
ClinicalTrials.gov ID: NCT04200885
Acronym / sponsor ID: 19-KAEK-100
Conditions: Third Molar Surgery
Keywords: Dexamethasone, Applied Kinesiology, Non-Steroidal Anti-Inflammatory Agents, Teeth, Impacted, Edema, Trismus, Postoperative Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Tokat Gaziosmanpasa UniversityUniversity, hospital or other
Study start: 2 May 2019 (actual)
Primary completion: 26 Aug 2019 (actual)
Study completion: 21 Nov 2019 (actual)
First posted: 16 Dec 2019 (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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Among the patients randomized because of severe postoperative sequelae expected as a result of radiological examination prior to surgical extraction of lower third molar teeth; postoperatively nonsteroid antiinflammatory drug prescribed group compared with preoperative single dose intraoral submucosal corticosteroid administration and postoperative therapeutic elastic bandage application.

Arm	Type	Receives
Postoperative NSAID Prescription	Active comparator	Drug: Dexketoprofen TrometamolPatients in this arm received common postoperative prescriptions following removal of their impacted third molars for seven days; twice a day 500 mg amoxicillin+125 mg clavulanic acid, twice a day 25 mg dexketoprofen trometamol and three times a day 1.5 mg/ml clorhexidine gluconate+1.2 mg/ml benzydamine hydrochloride containing 200 ml mouthwash.
Preoperative Submucosal Corticosteroid Injection	Active comparator	Drug: Dexamethasone 21-PhosphatePatients in this arm were administered 8mg/2ml dexamethasone 21-phosphate preoperatively after local anesthesia were obtained. Injection site was the depth of buccal sulcus near operation site. For the patients in this arm 25 mg dexketoprofen trometamol was excluded from postoperative prescription in order not to affect the anti-inflammatory effects of corticosteroid. Instead of NSAID, three times a day 500 mg paracetamol was prescribed. The patients were advised not to exceed maximal dosage of 3000 mg (6 tablets) in a day.
Postoperative Therapeutic Elastic Bandage Application	Active comparator	Device: Therapeutic Elastic BandageIn this arm the therapeutic elastic bandage applications were immediately performed after removal of mandibular third molars. The distance between tragus-lateral commissura line and supraclavicular lymph nodes was measured and the tapes were then cut into 5 tails. The base of the tape was placed on supraclavicular lymph nodes and tails were placed on the site to cover parotid, submandibular, submental and superficial cervical lymph nodes. The tapes were removed on postoperative second day.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age between 18-65 years
American Society of Anesthesiologists (ASA) Class 1 physiological status
Consistent radiological and clinical data
Volunteered to participate in the study
Surgical difficulty score above 5 which was determined according to Pederson scale.

Key exclusion criteria (12 listed)

Being out of age range
Analgesic or antibiotic therapy history in last 30 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

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
Dexketoprofen TrometamolAlso: Arveles 25 mg 20 tabletsPatients were instructed to record the number of drugs they used until the second and seventh postoperative days.	Drug	Postoperative NSAID Prescription
Dexamethasone 21-PhosphateAlso: Dekort 8mg/2ml Intramuscular (IM)/ Intravenous (IV)Injections were administered in the immediate preoperative period as a single shot.	Drug	Preoperative Submucosal Corticosteroid Injection
Therapeutic Elastic BandageAlso: Kinesio Tex Gold Fingerprint (FP)The bands' lengths were individually measured and divided into five equal parts up to 2/3 of their lengths to obtain fan-type shape.	Device	Postoperative Therapeutic Elastic Bandage Application

Primary outcome

Preoperative Pain Intensity
Time frame: On the day of surgery preoperatively
The patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain on the day of surgery preoperatively.
Change From Baseline Maximal Mouth Opening on Postoperative Follow Up Visits
Time frame: Preoperatively on the day of surgery, postoperative second and seventh days.
All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.
Change From Baseline Facial Measurements on Postoperative Follow Up Visits
Time frame: Preoperatively on the day of surgery, postoperative second and seventh days.
Measurements were performed on the ipsilateral site between tragus and lateral commissura, lateral canthus and angle of mandible with a flexible ruler. The obtained values' average amounts were calculated and recorded for each patient.
Oral Analgesic Consumption-1
Time frame: Postoperative Second Day
The patients were asked to record the amounts of consumed analgesic tablets (tablets per day) until first follow up visit.
Postoperative Pain Intensity-1
Time frame: Postoperative Second Day
The patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain.
Postoperative Pain Intensity-2
Time frame: Postoperative Seventh Day
The patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain.
Oral Analgesic Consumption-2
Time frame: Postoperative Seventh Day
The patients were asked to record the amounts of consumed analgesic tablets (tablets per day) between first and last follow up visits.

3 secondary outcomes

Wound Healing Scores
Time frame: Postoperative second and seventh days.
Oral Health Impact Profile
Time frame: Preoperatively on the day of surgery, postoperative second and seventh days.
Postoperative Symptom Severity Evaluation
Time frame: Postoperative seventh day.

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 17 Dec 2019.
Background: PubMed 23963616Ristow O, Hohlweg-Majert B, Sturzenbaum SR, Kehl V, Koerdt S, Hahnefeld L, Pautke C. Therapeutic elastic tape reduces morbidity after wisdom teeth removal--a clinical trial. Clin Oral Investig. 2014 May;18(4):1205-1212. doi: 10.1007/s00784-013-1067-3. Epub 2013 Aug 21.
Background: PubMed 23810681Alcantara CE, Falci SG, Oliveira-Ferreira F, Santos CR, Pinheiro ML. Pre-emptive effect of dexamethasone and methylprednisolone on pain, swelling, and trismus after third molar surgery: a split-mouth randomized triple-blind clinical trial. Int J Oral Maxillofac Surg. 2014 Jan;43(1):93-8. doi: 10.1016/j.ijom.2013.05.016. Epub 2013 Jun 28.
Background: PubMed 27752209Deo SP. Single-Dose of Submucosal Injection of Dexamethasone Affects the Post Operative Quality of Life After Third Molar Surgery. J Maxillofac Oral Surg. 2016 Sep;15(3):367-375. doi: 10.1007/s12663-015-0846-6. Epub 2015 Dec 7.
Derived from this study: PubMed 32803439Erdil A, Akbulut N, Altan A, Demirsoy MS. Comparison of the effect of therapeutic elastic bandage, submucosal dexamethasone, or dexketoprofen trometamol on inflammatory symptoms and quality of life following third molar surgery: a randomized clinical trial. Clin Oral Investig. 2021 Apr;25(4):1849-1857. doi: 10.1007/s00784-020-03487-y. Epub 2020 Aug 15.
Individual participant dataSharing planned: Yes. All individual participant data (IPD) related to study protocol and results will be shared during submitting as an article.

Related trials for Third Molar Surgery

Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
Periodontal Defect
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Recruiting
Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery
Dental Anxiety, Postoperative Pain
Not yet recruiting
Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery
Impacted Third Molar Tooth, Surgical Wound Healing

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.

Nihat Akbulut, Assoc. Dr. study director

Tokat Gaziosmanpasa University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 17 Dec 2019. 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 7 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 NCT04200885, 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 17 Dec 2019.