Tooth Extraction Status NosNCT03818906
Efficacy of aPDT in Reducing Pain and Swelling Following Molar Extraction Surgery- Blinded Randomized Controlled Clinical Trial
A study testing aPDT + Molar Extraction - Test Group 1, Infrared + Molar Extraction - Test Group 2 and aPDT + Infrared + Molar Extraction - Test Group 3 in people with Tooth Extraction Status Nos, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction Status Nos
- What is being tested?
- aPDT + Molar Extraction - Test Group 1, Infrared + Molar Extraction - Test Group 2 and aPDT + Infrared + Molar Extraction - Test Group 3
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2018to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Tooth Extraction Status Nos
- Being tested
- Molar extraction - Control Group, aPDT + Molar Extraction - Test Group 1, Infrared + Molar Extraction - Test Group 2, aPDT + Infrared + Molar Extraction - Test Group 3
- Keywords
- Photochemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molar extraction - Control GroupProcedure or surgery
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.
aPDT + Molar Extraction - Test Group 1Procedure or surgery
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.
Infrared + Molar Extraction - Test Group 2Procedure or surgery
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
aPDT + Infrared + Molar Extraction - Test Group 3Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: aPDT + Infrared + Molar Extraction - Test Group 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: The data will be collected in four moments: before the surgery, 72 hours, 7 days and 30 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Aug 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Extraction Status NosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia Azeredo Alves Antunes, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818906
- Sponsor's protocol ID
- PDTa and reducing pain
- Status last verified
- Nov 2022
- First submitted
- 24 Jan 2019
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of aPDT in Reducing Pain and Swelling Following Molar Extraction Surgery- Blinded Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03818906
- Acronym / sponsor ID
- PDTa and reducing pain
- Conditions
- Tooth Extraction Status Nos
- Keywords
- Photochemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Molar extraction - Control GroupPatients 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. |
| Test Group 1 | Experimental | Procedure: aPDT + Molar Extraction - Test Group 1Patients 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. |
| Test Group 2 | Experimental | Procedure: Infrared + Molar Extraction - Test Group 2Patients 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. |
| Test Group 3 | Experimental | Procedure: aPDT + Infrared + Molar Extraction - Test Group 3Patients 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molar extraction - Control GroupThe 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. | Procedure or surgery | Control Group |
| aPDT + Molar Extraction - Test Group 1The 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. | Procedure or surgery | Test Group 1 |
| Infrared + Molar Extraction - Test Group 2The 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 | Procedure or surgery | Test Group 2 |
| aPDT + Infrared + Molar Extraction - Test Group 3The 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. | Procedure or surgery | Test Group 3 |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aPDT + Molar Extraction - Test Group 1, Infrared + Molar Extraction - Test Group 2 and aPDT + Infrared + Molar Extraction - Test Group 3 in people with Tooth Extraction Status Nos, run by Universidade Federal Fluminense at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of postoperative pain (time frame: Pain evaluation will be performed prior to the surgical procedure and 7 days after). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.