Efficacy of aPDT in Reducing Pain and Swelling Following Molar Extraction Surgery- Blinded Randomized Controlled Clinical Trial

November 27, 2022 updated by: Livia Azeredo Alves Antunes, Universidade Federal Fluminense
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio De Janeiro
      • Nova Friburgo, Rio De Janeiro, Brazil, 28625650
        • Livia Antunes, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Patients with first or second molars where the extractions will be performed in a conventional way without any additional local treatment to be done in the alveolus. The analysis of the postoperative signs/symptoms will be performed by the visual analog pain scale at 1th, 2th, 3th, 4th, 5th, 6th, 7th. Subjective evaluation of swelling in 48 hours and 7th day.
Procedure: Molar extraction - Control Group
The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.
Experimental: Test Group 1
Patients with first or second molars where the extractions will be performed in a conventional way and after extraction will be performed aPDT inside the alveolus.The analysis of the postoperative signs/symptoms will be performed by the visual analog pain scale at 1th, 2th, 3th, 4th, 5th, 6th, 7th. Subjective evaluation of swelling in 48 hours and 7th day.
Procedure: aPDT + Molar Extraction - Test Group 1
The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.immediately after extraction, the fresh sockets will receive in their internal portion a local application of aPDT.
Experimental: Test Group 2
Patients with first or second molars where the extractions will be performed in a conventional way and immediately after the exodontia, the fresh socket will receive local application of infrared in the outer vestibular portion. The analysis of the postoperative signs/symptoms will be performed by the visual analog pain scale at 1th, 2th, 3th, 4th, 5th, 6th, 7th. Subjective evaluation of swelling in 48 hours and 7th day.
Procedure: Infrared + Molar Extraction - Test Group 2
The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.immediately after extraction, the fresh sockets will receive local application of infrared in vestibular external portion
Experimental: Test Group 3
Patients with first or second molars where the extractions will be performed in a conventional way and immediately after the exodontia the approaches from the previous groups (Test Group 1 and 2 (aPDT + infrared) will be done. The analysis of the postoperative signs/symptoms will be performed by the visual analog pain scale at 1th, 2th, 3th, 4th, 5th, 6th, 7th. Subjective evaluation of swelling in 48 hours and 7th day.
Procedure: aPDT + Infrared + Molar Extraction - Test Group 3
The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.immediately after extraction, the fresh sockets will receive in their internal portion a local application of aPDT and after that will receive local application of infrared in vestibular external portion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of postoperative pain
Time Frame: Pain evaluation will be performed prior to the surgical procedure and 7 days after
Evaluate Antimicrobial photodynamic therapy (aPDT)on the reduction of postoperative pain in lower molar extraction procedures. Pain intensity will be assessed through a visual analogue scale
Pain evaluation will be performed prior to the surgical procedure and 7 days after
reduction of swelling
Time Frame: The data will be collected in four moments: before the surgery, 72 hours, 7 days and 30 days postoperatively.
Evaluate Antimicrobial photodynamic therapy (aPDT)on the reduction of swelling. Swelling evaluated through the measurement of a perimeter between the tragus, the base of the mandible 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal Fluminense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 28, 2019

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 27, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PDTa and reducing pain

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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