Pain Clinical Trial
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
NCT number | NCT03393533 |
Other study ID # | Unesp |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 20, 2017 |
Est. completion date | August 4, 2018 |
Verified date | October 2018 |
Source | Universidade Estadual Paulista Júlio de Mesquita Filho |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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%.
Status | Completed |
Enrollment | 7 |
Est. completion date | August 4, 2018 |
Est. primary completion date | July 4, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 40 Years |
Eligibility |
Inclusion Criteria: 1. Patients with need for extraction of third molars, regardless of gender; 2. Teeth in opposite hemiarches with similar positions; 3. Between 15 and 40 years of age; 4. That they agree to participate in the research voluntarily. Exclusion Criteria: 1. Patients presenting with local or systemic alterations that contraindicate the procedure; 2. Use of anti-inflammatories in the last 15 days; 3. Third lower third molars in position and different inclusion classification on both sides; 4. Third erupted lower third molars. |
Country | Name | City | State |
---|---|---|---|
Brazil | Michelle Bianchi de Moraes | São José dos Campos | SP |
Lead Sponsor | Collaborator |
---|---|
Universidade Estadual Paulista Júlio de Mesquita Filho |
Brazil,
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-analys — View Citation
Maxwell C. Sensitivity and accuracy of the visual analogue scale: a psycho-physical classroom experiment. Br J Clin Pharmacol. 1978 Jul;6(1):15-24. — View Citation
UStün 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Trismus assessment with a millimeter rule. | Evaluated in patients in groups I and II | To measure the buccal opening, the distance between the incisal edges of the maxillary and mandibular incisors, obtained with the patient sitting upright. Evaluated in the pre and postoperative periods of 3 and 7 days | |
Primary | 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. | 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 | 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. | For investigators to measure facial edema, with pre and postoperative evaluations of 3 and 7 days |
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