NCT03818906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

January 24, 2019

Last Update Submit

November 27, 2022

Conditions

Tooth Extraction Status Nos

Keywords

Photochemotherapy

Outcome Measures

Primary Outcomes (2)

  • reduction of postoperative pain

    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

    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.

Study Arms (4)

Control Group

ACTIVE COMPARATOR

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

Test Group 1

EXPERIMENTAL

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

Test Group 2

EXPERIMENTAL

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

Test Group 3

EXPERIMENTAL

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

Interventions

Molar extraction - Control GroupPROCEDURE

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.

Control Group
aPDT + Molar Extraction - Test Group 1PROCEDURE

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.

Test Group 1
Infrared + Molar Extraction - Test Group 2PROCEDURE

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

Test Group 2
aPDT + Infrared + Molar Extraction - Test Group 3PROCEDURE

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.

Test Group 3

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Livia Antunes, PhD

Nova Friburgo, Rio de Janeiro, 28625650, Brazil

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Lívia Azeredo Alves Antunes

Study Record Dates

First Submitted

January 24, 2019

First Posted

January 28, 2019

Study Start

August 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations

BR(1)