Postoperative PainNCT05041738
Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain
A study testing Intraoral Cryotherapy and Intracanal Cryotherapy in people with Postoperative Pain, run by Cairo University.
Trial summary
The aim of this study is to clinically compare the efficacy of intraoral cryotherapy versus intracanal cryotherapy after single visit root canal therapy in lower molars with irreversible pulpitis and symptomatic apical periodontitis Read more about this study
- Who is it for?
- Ages 20 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Intraoral Cryotherapy and Intracanal Cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 1 Oct 2022
- 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 20 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy patient (ASA I or II).
- Mandibular first molar teeth with:
- Preoperative sharp pain and symptomatic apical periodontitis
- Absence or slight widening in the periodontal ligament (PDL).
- Vital response of pulp tissue to cold pulp tester (ethyl chloride spray) .
- Positive response to percussion test
Who cannot join
- Medically compromised patients.
- Pregnant women.
- Patients reporting bruxism or clenching.
- Patients allergic to ciprofloxacin or metronidazole.
- Teeth associated with acute periapical abscess and/or swelling.
- Greater than grade I mobility or pocket depth greater than 5mm.
Show all 10Show fewer
- Size of periapical radiolucency is greater than 8 mm.
- No restorability: Hopeless tooth.
- Immature teeth.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain in Lower Molar Teeth With Irreversible Pulpitis and Symptomatic Apical Periodontitis Randomized Clinical Trial
The aim of this study is to clinically compare the efficacy of intraoral cryotherapy versus intracanal cryotherapy after single visit root canal therapy in lower molars with irreversible pulpitis and symptomatic apical periodontitis
- Conditions
- Postoperative Pain
- Being tested
- Intraoral Cryotherapy, Intracanal Cryotherapy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoral CryotherapyProcedure or surgery
small ice packs wrapped in sterile gauze placed in the mouth on the vestibular surface of the treated tooth
Intracanal CryotherapyProcedure or surgery
Intracanal cryotherapy technique using 2.5°C cold saline irrigation as final irrigant
| Study group | Role | What they receive |
|---|---|---|
| Intraoral Cryotherapy | Experimental | Not described Receives: Procedure: Intraoral Cryotherapy |
| Intracanal Cryotherapy | Active comparator | Not described Receives: Procedure: Intracanal Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain assessed using Visual Analogue scale
Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
Measured: 6 hours post treatment
Postoperative pain assessed using Visual Analogue scale
Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
Measured: 12 hours post treatment
Postoperative pain assessed using Visual Analogue scale
Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
Measured: 24 hours post treatment
Secondary outcomes (2)
Postoperative pain assessed using Visual Analogue scale
Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
Measured: 48 hours post treatment
Postoperative pain assessed using Visual Analogue scale
Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
Measured: 72 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toka Mohamed Ezzat Kamel Soliman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041738
- Sponsor's protocol ID
- ENDO 3-3-5 8/9/2021
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fayyad DM, Abdelsalam N, Hashem N. Cryotherapy: A New Paradigm of Treatment in Endodontics. J Endod. 2020 Jul;46(7):936-942. doi: 10.1016/j.joen.2020.03.019. Epub 2020 May 6.
PubMed 32386857Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3.
PubMed 29398090
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain in Lower Molar Teeth With Irreversible Pulpitis and Symptomatic Apical Periodontitis Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05041738
- Acronym / sponsor ID
- ENDO 3-3-5 8/9/2021
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 13 Sep 2021 (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.
The aim of this study is to clinically compare the efficacy of intraoral cryotherapy versus intracanal cryotherapy after single visit root canal therapy in lower molars with irreversible pulpitis and symptomatic apical periodontitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoral Cryotherapy | Experimental | Procedure: Intraoral Cryotherapy |
| Intracanal Cryotherapy | Active comparator | Procedure: Intracanal Cryotherapy |
Who may qualify
- Ages
- 20 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Systemically healthy patient (ASA I or II).
- Preoperative sharp pain and symptomatic apical periodontitis
- Absence or slight widening in the periodontal ligament (PDL).
- Vital response of pulp tissue to cold pulp tester (ethyl chloride spray) .
- Positive response to percussion test
Key exclusion criteria (10 listed)
- Medically compromised patients.
- Pregnant women.
- Patients reporting bruxism or clenching.
- Patients allergic to ciprofloxacin or metronidazole.
- Teeth associated with acute periapical abscess and/or swelling.
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 |
|---|---|---|
| Intraoral Cryotherapysmall ice packs wrapped in sterile gauze placed in the mouth on the vestibular surface of the treated tooth | Procedure or surgery | Intraoral Cryotherapy |
| Intracanal CryotherapyIntracanal cryotherapy technique using 2.5°C cold saline irrigation as final irrigant | Procedure or surgery | Intracanal Cryotherapy |
Primary outcome
Postoperative pain assessed using Visual Analogue scale
Time frame: 6 hours post treatment
Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
Postoperative pain assessed using Visual Analogue scale
Time frame: 12 hours post treatment
Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
Postoperative pain assessed using Visual Analogue scale
Time frame: 24 hours post treatment
Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
2 secondary outcomes
Postoperative pain assessed using Visual Analogue scale
Time frame: 48 hours post treatment
Postoperative pain assessed using Visual Analogue scale
Time frame: 72 hours post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Background: PubMed 32386857Fayyad DM, Abdelsalam N, Hashem N. Cryotherapy: A New Paradigm of Treatment in Endodontics. J Endod. 2020 Jul;46(7):936-942. doi: 10.1016/j.joen.2020.03.019. Epub 2020 May 6.
- Background: PubMed 29398090Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoral Cryotherapy and Intracanal Cryotherapy in people with Postoperative Pain, run by Cairo University.
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 6 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: status not confirmed, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Toka M Ezzat, B.D.S. (Cairo University) (01005137002 ext. 002, toka.ezzat@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain assessed using Visual Analogue scale (time frame: 6 hours post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05041738, which also lists 2 linked publications.
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 13 Sep 2021.