Pain, ProceduralNCT05267847
The Success Rate of Cryotherapy Application in Primary Molars With Signs of Irreversible Pulpitis
A study testing Cryotherapy and Traditional local anesthesia in people with Pain, Procedural, run by Minia University at 1 site in Egypt.
Trial summary
The study is designed as a randomized controlled trial with two parallel groups. Children aged 5-9 years with primary molars from suffered symptomatic signs of irreversible pulpitis will be randomly assigned into two groups. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Procedural
- What is being tested?
- Cryotherapy and Traditional local anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Feb 2022to 30 Apr 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children are classified as I or II according to ASA
- Presence of at least one mandibular primary molar with symptomatic signs of irreversible pulpitis
- Presence of at least two-thirds of the root length in periapical radiograph
Who cannot join
- Unrestorable crowns
- Children with systemic, severe behavior or emotional problems
- Presence of gingival redness, swellings, fistulous of sinus tract
- Radiographic evidence of internal root resorption, pulp stones or calcifications, and/or bone radiolucency
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Omar Ahmed
Al Minyā, 61111
Omar Ahmed, PhD, 0020862347768, EG135.30708112400351@nies-edu.org
About this study
Official title: The Success Rate of Cryotherapy Application in Primary Molars With Signs of Irreversible
The study is designed as a randomized controlled trial with two parallel groups. Children aged 5-9 years with primary molars from suffered symptomatic signs of irreversible pulpitis will be randomly assigned into two groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block). For the second group, the mandibular second primary molars will be anesthetized using 4% articaine 1:100.000 epinephrine using inferior alveolar nerve block.
- Conditions
- Pain, Procedural
- Being tested
- Cryotherapy, Traditional local anesthesia
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
local anesthetic injection with articaine 4% 1:100,000 epinephrine then an application ice packs
Traditional local anesthesiaOther
local anesthetic injection with articaine 4% 1:100,000 epinephrine
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy during inferior alveolar nerve block | Experimental | Not described Receives: Other: Cryotherapy |
| Inferior alveolar nerve block | Active comparator | Not described Receives: Other: Traditional local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
Wong Backer pain scale
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start22 Feb 2022 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ProceduralStudies of the same condition, open and under way.
- More trials run by Minia 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Elheeny, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267847
- Sponsor's protocol ID
- 133
- Status last verified
- Mar 2022
- First submitted
- 22 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elheeny AAH, Sermani DI, Saliab EA, Turky M. Cryotherapy and pain intensity during endodontic treatment of mandibular first permanent molars with symptomatic irreversible pulpitis: A randomized controlled trial. Clin Oral Investig. 2023 Aug;27(8):4585-4593. doi: 10.1007/s00784-023-05084-1. Epub 2023 Jun 3.
PubMed 37268843
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Success Rate of Cryotherapy Application in Primary Molars With Signs of Irreversible
- ClinicalTrials.gov ID
- NCT05267847
- Acronym / sponsor ID
- 133
- Conditions
- Pain, Procedural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 22 Feb 2022 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 4 Mar 2022 (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 study is designed as a randomized controlled trial with two parallel groups. Children aged 5-9 years with primary molars from suffered symptomatic signs of irreversible pulpitis will be randomly assigned into two groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block). For the second group, the mandibular second primary molars will be anesthetized using 4% articaine 1:100.000 epinephrine using inferior alveolar nerve block.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy during inferior alveolar nerve block | Experimental | Other: Cryotherapy |
| Inferior alveolar nerve block | Active comparator | Other: Traditional local anesthesia |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children are classified as I or II according to ASA
- Presence of at least one mandibular primary molar with symptomatic signs of irreversible pulpitis
- Presence of at least two-thirds of the root length in periapical radiograph
Key exclusion criteria (4 listed)
- Unrestorable crowns
- Children with systemic, severe behavior or emotional problems
- Presence of gingival redness, swellings, fistulous of sinus tract
- Radiographic evidence of internal root resorption, pulp stones or calcifications, and/or bone radiolucency
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 |
|---|---|---|
| Cryotherapylocal anesthetic injection with articaine 4% 1:100,000 epinephrine then an application ice packs | Other | Cryotherapy during inferior alveolar nerve block |
| Traditional local anesthesialocal anesthetic injection with articaine 4% 1:100,000 epinephrine | Other | Inferior alveolar nerve block |
Primary outcome
Pain assessment
Time frame: up to 24 hours
Wong Backer pain scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Derived from this study: PubMed 37268843Elheeny AAH, Sermani DI, Saliab EA, Turky M. Cryotherapy and pain intensity during endodontic treatment of mandibular first permanent molars with symptomatic irreversible pulpitis: A randomized controlled trial. Clin Oral Investig. 2023 Aug;27(8):4585-4593. doi: 10.1007/s00784-023-05084-1. Epub 2023 Jun 3.
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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.
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 and Traditional local anesthesia in people with Pain, Procedural, run by Minia 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 3 inclusion and 4 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 4 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: up to 24 hours). 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 NCT05267847, which also lists 1 linked publication.
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 4 Mar 2022.