Clinical trial NCT03818906: Efficacy of aPDT in Reducing Pain and Swelling Following Molar Extraction Surgery- Blinded Randomized Controlled Clinical Trial
Official title: Efficacy of aPDT in Reducing Pain and Swelling Following Molar Extraction Surgery- Blinded Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction Status Nos
Keywords: Photochemotherapy
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project aims to evaluate the effect of antimicrobial photodynamic therapy (aPDT) on the reduction of swelling and postoperative pain in lower molar extraction procedures. This is a clinical study approved by the Research Ethics Committee, which will be performed in 40 patients between 20 and 60 years. Patients included in the study should have at least one lower molar (first or second molar) with indication of exodontia. Participants will follow the exclusion criteria: pregnant or breastfeeding women; patients with obesity (Body Mass Index - BMI); make use of any activity smokers and ex smoker to 6 months; diabetics; immunosuppressed; in osteoporosis; making use of antimicrobials in the last 3 months; making use of medications that interfere with bone remodeling; with cysts or tumors in place. Surgical procedures that exceeded the clinical time of 30 minutes and / or required opening of the flap or osteotomy were excluded from the study. After the sample calculation, forty patients will be involved in this project, where forty molars (first and second molars) will be extracted in the mandible, which will be randomly divided into 4 groups. The control group (C.G), will contain 10 patients, where 10 molars will be extracted in a conventional way, without any additional treatment to be done. Test group 1 (T.G1) will contain 10 patients where 10 molars will be extracted and immediately after extraction, the fresh sockets will receive in their inner portion a local application of aPDT. The test group 2 (T.G2) will present 10 patients, where 10 molars will be extracted that immediately after the exodontia, the fresh socket will receive local application of infrared in the outer vestibular portion. Finally, Test Group 3 (T.G3), will be composed of 10 patients, where 10 molars will be extracted, joining the approaches of the previous groups (aPDT + infrared). Pain intensity will be assessed through a visual analogue scale and swelling assessed by measuring a perimeter between the tragus, the base of the jaw and the commissure of the lips. The data will be collected in four moments: before the surgery, 72 hours, 7 days and 30 days postoperatively.


Eligibility criteria: Inclusion Criteria:

* patients without systemic limitations that indicate surgical procedures with cooperative behavior
* with full awareness and approval of the guidelines listed in the free and clarified term proposed by the research
* present compromised posterior and inferior teeth requiring exodontia.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients with obesity (Body Mass Index - BMI)
* Make use of any activity smokers and ex smoker to 6 months
* Diabetics
* Immunosuppressed
* in osteoporosis
* making use of antimicrobials in the last 3 months
* making use of medications that interfere with bone remodeling
* with cysts or tumors in place
* Surgical procedures that exceeded the clinical time of 30 minutes and / or required opening of the flap or osteotomy

Primary outcomes:
measure: reduction of postoperative pain
timeFrame: Pain evaluation will be performed prior to the surgical procedure and 7 days after
measure: reduction of swelling
timeFrame: The data will be collected in four moments: before the surgery, 72 hours, 7 days and 30 days postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Nova Friburgo
country: Brazil
facility: Livia Antunes, PhD
state: Rio De Janeiro
Study officials:
References: