PainNCT03393533
Evaluation of the Effectiveness of the Use of the Therapeutic Bandage Method in Third Molar Surgery
A study testing Group I and Group II in people with Pain, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
Extraction of lower third molars semi-included or included is one of the most performed procedures in oral surgery, and inherent to the procedure there is a postoperative inflammatory response. Among the factors most routine to this response are pain, edema and trismus. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Group I and Group II
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2017to 4 Aug 2018
- Phase
- Interventional
- 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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with need for extraction of third molars, regardless of gender;
- Teeth in opposite hemiarches with similar positions;
- Between 15 and 40 years of age;
- That they agree to participate in the research voluntarily.
Who cannot join
- Patients presenting with local or systemic alterations that contraindicate the procedure;
- Use of anti-inflammatories in the last 15 days;
- Third lower third molars in position and different inclusion classification on both sides;
- Third erupted lower third molars.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Michelle Bianchi de Moraes
São José dos Campos, São Paulo, 12245000
About this study
Official title: Evaluation of the Effectiveness of the Use of the Therapeutic Bandage Method in Third Molar Surgery. Splint-mouth Randomized Blind Controlled Clinical Trial
Extraction of lower third molars semi-included or included is one of the most performed procedures in oral surgery, and inherent to the procedure there is a postoperative inflammatory response. Among the factors most routine to this response are pain, edema and trismus. The therapy taping has advantages in its use in the physiotherapy of several specialities, leading to the correction of muscular functions, reduction of edema, muscular spasms and reduction of pain. Thus, the objective of this split mouth, randomized, blind, clinical trial will be to evaluate the postoperative period of 32 third molars in the patients from the São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, Brasil. These evaluations will be performed on the third and seventh days after the extraction, where the patients will be analyzed by evaluator who will measure the edema, the opening of the mouth (evaluation of muscle spasm) and collect the pain table delivered in the immediate postoperative period, comparing thus, the benefit of therapeutic banding in the postoperative period of the extraction of lower third molars. The analogue pain scale (VAS), together with the Ustün et al. (2003) and the millimeter rule will be used to compare the data and the results will be submitted to descriptive statistics and compared by means of the statistical analysis of variance (ANOVA) and Tukey test with significance level of 5%.
Read the detailed description
Extraction of third molars is the procedure of oral and maxillofacial surgery most commonly performed around the world, usually at the outpatient level. Its execution may result in the appearance of reversible and / or irreversible disorders, but the most observed signs and symptoms are pain, edema and trismus to a greater or lesser degree. Thus, there seems to be no consensus within the literature for a better type of post-surgical treatment that leads to less patient discomfort when undergoing this kind of surgery.
The objective of this randomized, blinded trial will be to evaluate the use of therapeutic bandaging, Therapy Tex ©, In reducing the signs and symptoms inherent to the postoperative period of the third molar extracts, semi-included or included .
The sample will consist of 32 lower third molars, semi-inclusively or included, divided into two groups simultaneously, namely:
Group I (16 teeth) - without therapeutic bandaging on face. Group II (16 teeth) - with therapeutic bandaging on face. The therapeutic bandaging method will be applied in the patients of group II, according to the previous randomization.The bandage will be applied immediately after surgery and before the end of the anesthetic effect. The skin should be cleaned with 70% alcohol in order to remove residue and oiliness, and then should be dried. If necessary, scrape the hairs of the region in which the tape will rest. The application of the bandage will be in the proposed regions using the "I" cutout, in which no additional trimming is made on the tape. The length may vary depending on the size of the patient's face. After being applied the bandage should be gently wiped to activate the acrylic components that generate adhesiveness and should remain on the face for 3 days.
The patient is asked to occlude, the dimension of the masseter muscle is determined by palpation. During palpation, point A is selected in the lower portion of the zygomatic arch and point B is close to the angle of the mandible. The tape will be placed along the direction of the muscle fibers.
Placement of the second tape will occur from the mandibular angle to the mental symphysis, accompanying the entire mandibular body in its medial portion covering the milo-hyoid muscles and the anterior belly of the digastric.
The results of the clinical evaluations will be submitted to descriptive statistics and compared by means of the statistical analysis of variance (ANOVA) and Tukey test with significance level of 5%.
- Conditions
- Pain
- Being tested
- Group I, Group II
- Keywords
- Third molar;, Oral surgery;, Pain;, Edema;, Trismus.
- Medical subject headings
- Pain, Edema, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group IProcedure or surgery
Extraction third molar without the application of therapeutic bandaging in the face and with evaluation of edema, pain and trismus
Group IIProcedure or surgery
Extraction third molar with the application of therapeutic bandaging in the face and with evaluation of edema, pain and trismus
| Study group | Role | What they receive |
|---|---|---|
| Group I | Other | Extraction third molar with pre and postoperative evaluation of edema, pain and trismus Receives: Procedure: Group II |
| Group II | Active comparator | Extraction third molar with therapeutic bandage pre and postoperative evaluation of edema, pain and trismus Receives: Procedure: Group I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
Evaluated in patients in groups I and II. Scale of vas, with values from zero to ten, being zero without pain and ten the maximum of pain. This scale will be provided on paper and divided into postoperative hours up to 3 days.
Measured: The scale will be provided on paper and divided into postoperative hours up to 3 days for the patient to note the degree of pain that varies between zero and ten
Secondary outcomes (1)
Edema assessment with a millimeter rule.
Evaluated in patients in groups I and II. Used the method of Ustün et al. (2003) with a millimeter rule to obtain the measures.
Measured: For investigators to measure facial edema, with pre and postoperative evaluations of 3 and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start20 Oct 2017
- Primary completion4 Jul 2018
- Study completion4 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample will consist of 32 lower third molars, semi-inclusively or included. This study will be a randomized, blind, controlled, split-mouth clinical trial, divided into two groups simultaneously, namely: Group I (16 teeth) - without therapeutic banding on the face, after the third molar extraction. Group II (16 teeth) - with therapeutic banding on the face, after the third molar extraction.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Bianchi de Moraes, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Michelle B Moraes, PHD, Principal investigator, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393533
- Sponsor's protocol ID
- Unesp
- Status last verified
- Oct 2018
- First submitted
- 5 Dec 2017
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brignardello-Petersen R, Carrasco-Labra A, Araya I, Yanine N, Beyene J, Shah PS. Is adjuvant laser therapy effective for preventing pain, swelling, and trismus after surgical removal of impacted mandibular third molars? A systematic review and meta-analysis. J Oral Maxillofac Surg. 2012 Aug;70(8):1789-801. doi: 10.1016/j.joms.2012.01.008. Epub 2012 Mar 6.
PubMed 22398186UStun Y, Erdogan O, Esen E, Karsli ED. Comparison of the effects of 2 doses of methylprednisolone on pain, swelling, and trismus after third molar surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Nov;96(5):535-9. doi: 10.1016/S1079210403004645.
PubMed 14600686Maxwell C. Sensitivity and accuracy of the visual analogue scale: a psycho-physical classroom experiment. Br J Clin Pharmacol. 1978 Jul;6(1):15-24. doi: 10.1111/j.1365-2125.1978.tb01676.x.
PubMed 666944
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Use of the Therapeutic Bandage Method in Third Molar Surgery. Splint-mouth Randomized Blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03393533
- Acronym / sponsor ID
- Unesp
- Conditions
- Pain
- Keywords
- Third molar;, Oral surgery;, Pain;, Edema;, Trismus.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 4 Aug 2018 (actual)
- First posted
- 8 Jan 2018 (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.
Extraction of lower third molars semi-included or included is one of the most performed procedures in oral surgery, and inherent to the procedure there is a postoperative inflammatory response. Among the factors most routine to this response are pain, edema and trismus. The therapy taping has advantages in its use in the physiotherapy of several specialities, leading to the correction of muscular functions, reduction of edema, muscular spasms and reduction of pain. Thus, the objective of this split mouth, randomized, blind, clinical trial will be to evaluate the postoperative period of 32 third molars in the patients from the São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, Brasil. These evaluations will be performed on the third and seventh days after the extraction, where the patients will be analyzed by evaluator who will measure the edema, the opening of the mouth (evaluation of muscle spasm) and collect the pain table delivered in the immediate postoperative period, comparing thus, the benefit of therapeutic banding in the postoperative period of the extraction of lower third molars. The analogue pain scale (VAS), together with the Ustün et al. (2003) and the millimeter rule will be used to compare the data and the results will be submitted to descriptive statistics and compared by means of the statistical analysis of variance (ANOVA) and Tukey test with significance level of 5%.
Detailed description
Extraction of third molars is the procedure of oral and maxillofacial surgery most commonly performed around the world, usually at the outpatient level. Its execution may result in the appearance of reversible and / or irreversible disorders, but the most observed signs and symptoms are pain, edema and trismus to a greater or lesser degree. Thus, there seems to be no consensus within the literature for a better type of post-surgical treatment that leads to less patient discomfort when undergoing this kind of surgery.
The objective of this randomized, blinded trial will be to evaluate the use of therapeutic bandaging, Therapy Tex ©, In reducing the signs and symptoms inherent to the postoperative period of the third molar extracts, semi-included or included .
The sample will consist of 32 lower third molars, semi-inclusively or included, divided into two groups simultaneously, namely:
Group I (16 teeth) - without therapeutic bandaging on face. Group II (16 teeth) - with therapeutic bandaging on face. The therapeutic bandaging method will be applied in the patients of group II, according to the previous randomization.The bandage will be applied immediately after surgery and before the end of the anesthetic effect. The skin should be cleaned with 70% alcohol in order to remove residue and oiliness, and then should be dried. If necessary, scrape the hairs of the region in which the tape will rest. The application of the bandage will be in the proposed regions using the "I" cutout, in which no additional trimming is made on the tape. The length may vary depending on the size of the patient's face. After being applied the bandage should be gently wiped to activate the acrylic components that generate adhesiveness and should remain on the face for 3 days.
The patient is asked to occlude, the dimension of the masseter muscle is determined by palpation. During palpation, point A is selected in the lower portion of the zygomatic arch and point B is close to the angle of the mandible. The tape will be placed along the direction of the muscle fibers.
Placement of the second tape will occur from the mandibular angle to the mental symphysis, accompanying the entire mandibular body in its medial portion covering the milo-hyoid muscles and the anterior belly of the digastric.
The results of the clinical evaluations will be submitted to descriptive statistics and compared by means of the statistical analysis of variance (ANOVA) and Tukey test with significance level of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The sample will consist of 32 lower third molars, semi-inclusively or included. This study will be a randomized, blind, controlled, split-mouth clinical trial, divided into two groups simultaneously, namely: Group I (16 teeth) - without therapeutic banding on the face, after the third molar extraction. Group II (16 teeth) - with therapeutic banding on the face, after the third molar extraction.
| Arm | Type | Receives |
|---|---|---|
| Group I | Other | Procedure: Group IIExtraction third molar with pre and postoperative evaluation of edema, pain and trismus |
| Group II | Active comparator | Procedure: Group IExtraction third molar with therapeutic bandage pre and postoperative evaluation of edema, pain and trismus |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with need for extraction of third molars, regardless of gender;
- Teeth in opposite hemiarches with similar positions;
- Between 15 and 40 years of age;
- That they agree to participate in the research voluntarily.
Key exclusion criteria (4 listed)
- Patients presenting with local or systemic alterations that contraindicate the procedure;
- Use of anti-inflammatories in the last 15 days;
- Third lower third molars in position and different inclusion classification on both sides;
- Third erupted lower third molars.
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 |
|---|---|---|
| Group IExtraction third molar without the application of therapeutic bandaging in the face and with evaluation of edema, pain and trismus | Procedure or surgery | Group II |
| Group IIExtraction third molar with the application of therapeutic bandaging in the face and with evaluation of edema, pain and trismus | Procedure or surgery | Group I |
Primary outcome
Pain assessment
Time frame: The scale will be provided on paper and divided into postoperative hours up to 3 days for the patient to note the degree of pain that varies between zero and ten
Evaluated in patients in groups I and II. Scale of vas, with values from zero to ten, being zero without pain and ten the maximum of pain. This scale will be provided on paper and divided into postoperative hours up to 3 days.
1 secondary outcome
Edema assessment with a millimeter rule.
Time frame: For investigators to measure facial edema, with pre and postoperative evaluations of 3 and 7 days
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 10 Oct 2018.
- Results publication: PubMed 22398186Brignardello-Petersen R, Carrasco-Labra A, Araya I, Yanine N, Beyene J, Shah PS. Is adjuvant laser therapy effective for preventing pain, swelling, and trismus after surgical removal of impacted mandibular third molars? A systematic review and meta-analysis. J Oral Maxillofac Surg. 2012 Aug;70(8):1789-801. doi: 10.1016/j.joms.2012.01.008. Epub 2012 Mar 6.
- Results publication: PubMed 14600686UStun Y, Erdogan O, Esen E, Karsli ED. Comparison of the effects of 2 doses of methylprednisolone on pain, swelling, and trismus after third molar surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Nov;96(5):535-9. doi: 10.1016/S1079210403004645.
- Results publication: PubMed 666944Maxwell C. Sensitivity and accuracy of the visual analogue scale: a psycho-physical classroom experiment. Br J Clin Pharmacol. 1978 Jul;6(1):15-24. doi: 10.1111/j.1365-2125.1978.tb01676.x.
- Individual participant dataSharing planned: No
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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.
Michelle B Moraes, PHD principal investigator
Universidade Estadual Paulista Júlio de Mesquita Filho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group I and Group II in people with Pain, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
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 4 inclusion and 4 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 10 Oct 2018. 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 Brazil. 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.
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?
Pain assessment (time frame: The scale will be provided on paper and divided into postoperative hours up to 3 days for the patient to note the degree of pain that varies between zero and ten). 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 NCT03393533, which also lists 3 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 10 Oct 2018.