Irriversible Pulpitis With Apical PeridontitisLLLTNCT06657664
Effect of Cryotherapy and Laser Application on Post-Operative Pain in Single Visit Endodontically Treated Symptomatic Apical Periodontitis Cases
A study testing cryotherapy with sterile saline at 2.5ºC, intaoral cryotherapy and Both intracanal and intraoral cryotherapy in people with Irriversible Pulpitis With Apical Peridontitis and Hot Tooth, run by Tanta University at 1 site in Egypt.
Trial summary
This study compare the effect of applying ice after single visit endodontic treatment with lasers to reduce post operative pain . Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Irriversible Pulpitis With Apical Peridontitis, Hot Tooth
- What is being tested?
- cryotherapy with sterile saline at 2.5ºC, intaoral cryotherapy and Both intracanal and intraoral cryotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 10 Oct 2024
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Vital teeth display symptomatic apical periodontitis (Symptomatic apical periodontitis was determined based on the clinical symptoms of severe preoperative pain (visual analogue scale [VAS] > 60) and severe percussion pain (VAS > 60).
- Teeth, with a periapical index score (PAI) of 2 or 3 indicating small changes in bone structure and slight mineral loss respectively.
- Mobility less than 1 mm in either direction.
- Absence of periodontal pocket around the tooth.
- Symptomatic pulpitis with spontaneous pain or lingered by cold or heat.
- Teeth without pus or inflammatory exudates draining through the canal.
- Teeth without anatomic variations
Who cannot join
- • Patient with any systemic disease.
- Immunocompromised patients.
- Pregnant or lactating patients.
- Apparently narrow roots in which apical preparation with the #40 file would be overzealous.
- Retreatment cases.
- Necrotic painful teeth with absence of sinus tract for drainage.
- Patients on analgesics or sedative medication up to 6 hours before treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cryotherapy and Laser on Post-Operative Pain in Single Visit Endodontically Treated Symptomatic Apical Periodontitis Cases
This study compare the effect of applying ice after single visit endodontic treatment with lasers to reduce post operative pain .
Read the detailed description
one of the most popular complications after single visit endodontic treatment is pain either spontaneous or on biting so in this study we choose one of the most difficult and challenging cases " Hot tooth " to compare lasers and cryotherapy different applications to reduce post operative pain after single visit endodontic treatment
- Being tested
- cryotherapy with sterile saline at 2.5ºC, intaoral cryotherapy, Both intracanal and intraoral cryotherapy, Low Level Laser Therapy, Control (Standard treatment)
- Keywords
- cryotherapy Low Level Laser Therapy LLLT single visit endodontic treatment irriversible pulpitis Apical peridontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapy with sterile saline at 2.5ºCProcedure or surgery
Also called iced intracanal saline, intracanal cryotherapy
the root canals are given a final irrigation with 20 mL cold (2.5oC) saline solution for 5 minutes before obturation
intaoral cryotherapyProcedure or surgery
ice sticks (wrapped in sterile gauze if needed) using plastic pipette droppers filled with freezed sterile water are placed intraorally in the mouth on the apices of the treated tooth on both buccal and palatal sides for 30 minutes
Both intracanal and intraoral cryotherapyProcedure or surgery
Canal is irrigated with iced saline for 5 minutes before obturation . Root canal is obturated and coronal restoration is done. Then, application of intraoral cryotherapy is performed by ice sticks for 30 minutes.
Low Level Laser TherapyDevice
Also called photobiomodulation, LLLT, cold lasers
laser irradiation on the soft tissues covering the apices of the tooth on both buccal and palatal surfaces respectively
Control (Standard treatment)Procedure or surgery
Also called occlusal reduction
, all occlusal contacts were reduced by 1 mm
| Study group | Role | What they receive |
|---|---|---|
| control Group | Active comparator | all occlusal contacts are reduced by 1 mm Receives: Procedure: Control (Standard treatment) |
| intracanal cryotherapy | Active comparator | the root canals are given a final irrigation with 20 mL cold (2.5oC) saline solution for 5 minutes Receives: Procedure: cryotherapy with sterile saline at 2.5ºC |
| intraoral cryotherapy group | Active comparator | ice sticks (wrapped in sterile gauze if needed) using plastic pipette droppers filled with freezing sterile water are placed intraorally in the mouth on the apices of the treated tooth on both buccal and palatal sides for 30 minutes Receives: Procedure: intaoral cryotherapy |
| Both intracanal and intraoral cryotherapy | Active comparator | the root canals are given a final irrigation with 20 mL cold (2.5oC) saline solution for 5 minutes , the canal is obturated and then ice sticks (wrapped in sterile gauze if needed) using plastic pipette droppers filled with freezing sterile water are placed intraorally in the mouth on the apices of the treated tooth on both buccal and palatal sides for 30 minutes. Receives: Procedure: Both intracanal and intraoral cryotherapy |
| Low Level Laser Therapy | Active comparator | laser irradiation on the soft tissues covering the apices of the tooth on both buccal and palatal surfaces respectively. Receives: Device: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
post operative pain and pain on percussion is tested using visual analogue scale
Measured: preoperative, after 24 hours, on the third , fifth, one week & two weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Aug 2023
- Primary completion1 Sep 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irriversible Pulpitis With Apical PeridontitisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Model description
- This is a randomized clinical study.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawda Nashy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657664
- Sponsor's protocol ID
- TantaU 55
- Acronym
- LLLT
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cryotherapy and Laser on Post-Operative Pain in Single Visit Endodontically Treated Symptomatic Apical Periodontitis Cases
- ClinicalTrials.gov ID
- NCT06657664
- Acronym / sponsor ID
- LLLT / TantaU 55
- Keywords
- cryotherapy Low Level Laser Therapy LLLT single visit endodontic treatment irriversible pulpitis Apical peridontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 24 Oct 2024 (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 study compare the effect of applying ice after single visit endodontic treatment with lasers to reduce post operative pain .
Detailed description
one of the most popular complications after single visit endodontic treatment is pain either spontaneous or on biting so in this study we choose one of the most difficult and challenging cases " Hot tooth " to compare lasers and cryotherapy different applications to reduce post operative pain after single visit endodontic treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- This is a randomized clinical study.
| Arm | Type | Receives |
|---|---|---|
| control Group | Active comparator | Procedure: Control (Standard treatment)all occlusal contacts are reduced by 1 mm |
| intracanal cryotherapy | Active comparator | Procedure: cryotherapy with sterile saline at 2.5ºCthe root canals are given a final irrigation with 20 mL cold (2.5oC) saline solution for 5 minutes |
| intraoral cryotherapy group | Active comparator | Procedure: intaoral cryotherapyice sticks (wrapped in sterile gauze if needed) using plastic pipette droppers filled with freezing sterile water are placed intraorally in the mouth on the apices of the treated tooth on both buccal and palatal sides for 30 minutes |
| Both intracanal and intraoral cryotherapy | Active comparator | Procedure: Both intracanal and intraoral cryotherapythe root canals are given a final irrigation with 20 mL cold (2.5oC) saline solution for 5 minutes , the canal is obturated and then ice sticks (wrapped in sterile gauze if needed) using plastic pipette droppers filled with freezing sterile water are placed intraorally in the mouth on the apices of the treated tooth on both buccal and palatal sides for 30 minutes. |
| Low Level Laser Therapy | Active comparator | Device: Low Level Laser Therapylaser irradiation on the soft tissues covering the apices of the tooth on both buccal and palatal surfaces respectively. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Vital teeth display symptomatic apical periodontitis (Symptomatic apical periodontitis was determined based on the clinical symptoms of severe preoperative pain (visual analogue scale [VAS] > 60) and severe percussion pain (VAS > 60).
Key exclusion criteria (7 listed)
- • Patient with any systemic disease.
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 |
|---|---|---|
| cryotherapy with sterile saline at 2.5ºCAlso: iced intracanal saline, intracanal cryotherapythe root canals are given a final irrigation with 20 mL cold (2.5oC) saline solution for 5 minutes before obturation | Procedure or surgery | intracanal cryotherapy |
| intaoral cryotherapyice sticks (wrapped in sterile gauze if needed) using plastic pipette droppers filled with freezed sterile water are placed intraorally in the mouth on the apices of the treated tooth on both buccal and palatal sides for 30 minutes | Procedure or surgery | intraoral cryotherapy group |
| Both intracanal and intraoral cryotherapyCanal is irrigated with iced saline for 5 minutes before obturation . Root canal is obturated and coronal restoration is done. Then, application of intraoral cryotherapy is performed by ice sticks for 30 minutes. | Procedure or surgery | Both intracanal and intraoral cryotherapy |
| Low Level Laser TherapyAlso: photobiomodulation, LLLT, cold laserslaser irradiation on the soft tissues covering the apices of the tooth on both buccal and palatal surfaces respectively | Device | Low Level Laser Therapy |
| Control (Standard treatment)Also: occlusal reduction, all occlusal contacts were reduced by 1 mm | Procedure or surgery | control Group |
Primary outcome
post operative pain
Time frame: preoperative, after 24 hours, on the third , fifth, one week & two weeks after treatment
post operative pain and pain on percussion is tested using visual analogue scale
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 24 Oct 2024.
- Individual participant dataSharing planned: Undecided
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 cryotherapy with sterile saline at 2.5ºC, intaoral cryotherapy and Both intracanal and intraoral cryotherapy in people with Irriversible Pulpitis With Apical Peridontitis and Hot Tooth, run by Tanta University at 1 site in Egypt.
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 7 inclusion and 7 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 24 Oct 2024. 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 Egypt. 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?
post operative pain (time frame: preoperative, after 24 hours, on the third , fifth, one week & two weeks after treatment). 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 24 Oct 2024.