Evaluation of the Effectiveness of the Use of the Therapeutic Bandage Method in Third Molar Surgery

NCT03393533 | Completed DMC

• 1 other identifier: Unesp
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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. 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%.

Conditions

Pain

Keywords

Third molar;; Oral surgery;; Pain;; Edema;; Trismus.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Edema assessment with a millimeter rule.

  For investigators to measure facial edema, with pre and postoperative evaluations of 3 and 7 days

Other Outcomes (1)

• Trismus assessment with a millimeter rule.

  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

Study Arms (2)

Group I

OTHER

Extraction third molar with pre and postoperative evaluation of edema, pain and trismus

Procedure: Group II

Group II

ACTIVE COMPARATOR

Extraction third molar with therapeutic bandage pre and postoperative evaluation of edema, pain and trismus

Procedure: Group I

Interventions

Group I PROCEDURE

Extraction third molar without the application of therapeutic bandaging in the face and with evaluation of edema, pain and trismus

Group II

Group II PROCEDURE

Extraction third molar with the application of therapeutic bandaging in the face and with evaluation of edema, pain and trismus

Group I

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients presenting with local or systemic alterations that contraindicate the procedure;
• Use of anti-inflammatories in the last 15 days;
• Third erupted lower third molars.

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

Michelle Bianchi de Moraes

São José dos Campos, São Paulo, 12245000, Brazil

Location

Related Publications (3)

• 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.

  PMID: 22398186 RESULT

• UStun 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.

  PMID: 14600686 RESULT

• 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. doi: 10.1111/j.1365-2125.1978.tb01676.x.

  PMID: 666944 RESULT

MeSH Terms

Conditions

Pain; Edema; Trismus

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Study Officials

• Michelle B Moraes, PHD

  Universidade Estadual Paulista Júlio de Mesquita Filho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Surgical procedures were always performed by the same surgeon and assistant, who was unaware of the group that belonged to the patient, as well as the patient himself. This randomization was performed involving numbers and envelopes, being only the investigator's knowledge.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Diagnosis and Surgery, São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, Brazil.

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: January 8, 2018
• Study Start: October 20, 2017
• Primary Completion: July 4, 2018
• Study Completion: August 4, 2018
• Last Updated: October 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)