Root Canal Treatment in Children Primary MolarsNCT07138937
Efficiency of Sonic Activation During Root Canal Treatment of Primary Molars on Postoperative Pain and Facial Expressions
A study testing Root canal treatment in primary molars with irreversible pulpitis, EDDY system for sonic activation of irrigation and side-vented needle in people with Root Canal Treatment in Children Primary Molars and Postoperative Pain, run by Suez Canal University at 1 site in Egypt.
Trial summary
This study was conducted to evaluate the efficiency of sonic activation of 5%sodium hypochlorite during root canal treatment of primary molars on postoperative pain and facial expressions. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Root Canal Treatment in Children Primary Molars, Postoperative Pain, Facial Expressions
- What is being tested?
- Root canal treatment in primary molars with irreversible pulpitis, EDDY system for sonic activation of irrigation and side-vented needle
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 1 Mar 2025
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children's age range 5-8 years. Boys and girls will be included.
- Children with positive or definitely positive behavior on the Frankl's behavior rating scale (rating 3 or 4 on the scale).
- Children with at least one primary molar with irreversible pulpitis and symptomatic apical periodontitis confirmed using periapical radiographs, percussion, and cold test.
- Children having teeth with two-thirds of each root remaining.
- Children with a moderate to very severe (2-4) pain score according to five-face pain scale in only one tooth within the 24-h period before the procedure.
- Children with no allergy to Ibuprofen.
Who cannot join
- Teeth with pathological root resorption.
- Teeth with mobility greater than 1st-degree mobility.
- Children who received analgesics and/or antibiotics in the last 12 h before root canal treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of Sonic Activation During Root Canal Treatment of Primary Molars on Postoperative Pain and Facial Expressions of Children Using Artificial Intelligence
This study was conducted to evaluate the efficiency of sonic activation of 5%sodium hypochlorite during root canal treatment of primary molars on postoperative pain and facial expressions. In addition to comparing between the Five-face pain scale and AI Emotion Detector mobile application in postoperative pain assessment.
Read the detailed description
The current study addresses an important gap in research, as the impact of sonic activation of irrigation on postoperative pain in children and the validity of artificial intelligence mobile application in detecting facial expressions following root canal treatment as not been well explored.
- Conditions
- Root Canal Treatment in Children Primary Molars, Postoperative Pain, Facial Expressions, Facial Emotions, Artificial Intelligence Mobile Application, Sonic Activation
- Being tested
- Root canal treatment in primary molars with irreversible pulpitis, EDDY system for sonic activation of irrigation, side-vented needle
- Keywords
- Sonic activation, Postoperative pain, Primary molars, AI applications, Facial emotions
- Medical subject headings
- Pain, Postoperative, Facial Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatment in primary molars with irreversible pulpitisProcedure or surgery
Root canal treatment in primary molars with irreversible pulpitis followed by coronal restoration with stainless-steel crowns in a single visit.
EDDY system for sonic activation of irrigationDevice
sonic activation of irrigation with EDDY system during root canal treatment in primary molars
side-vented needleDevice
conventional irrigation with side-vented needle without activation during root canal treatment in primary molars
| Study group | Role | What they receive |
|---|---|---|
| Sonic activation of irrigation | Active comparator | Sonic activation of irrigation with Eddy system Receives: Procedure: Root canal treatment in primary molars with irreversible pulpitis; Device: EDDY system for sonic activation of irrigation |
| No activation | Placebo comparator | Irrigation with side-vented needle without activation Receives: Procedure: Root canal treatment in primary molars with irreversible pulpitis; Device: side-vented needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five-Face Pain Scale Score
Postoperative pain is assessed using the Five-Face Pain Scale (range: 0 = no pain to 4= worst pain; lower scores indicate less pain).
Unit of Measure: Scale units (0-4)
Measured: 8 ,24,48,72 hours, and after 1week post-operative
facial expressions analysis
facial expressions of the patients are assessed from their photographs and analyzed by the AI Emotion Detector mobile application.
Unit of Measure: Percentage (%)
Measured: 8 ,24,48,72 hours, and after 1week post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Aug 2024
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal Treatment in Children Primary MolarsStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- A comparative, randomized, prospective clinical trial to evaluate the efficacy of sonic activation versus no activation by comparing the pain scale and facial expressions following root canal treatment in primary molars.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghada Abdelhamid El-Baz, Professor of Pedodontics, Study chair, Faculty of dentisrty, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138937
- Sponsor's protocol ID
- 728/2024
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Sonic Activation During Root Canal Treatment of Primary Molars on Postoperative Pain and Facial Expressions of Children Using Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07138937
- Acronym / sponsor ID
- 728/2024
- Conditions
- Root Canal Treatment in Children Primary Molars, Postoperative Pain, Facial Expressions, Facial Emotions, Artificial Intelligence Mobile Application, Sonic Activation
- Keywords
- Sonic activation, Postoperative pain, Primary molars, AI applications, Facial emotions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 24 Aug 2025 (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 was conducted to evaluate the efficiency of sonic activation of 5%sodium hypochlorite during root canal treatment of primary molars on postoperative pain and facial expressions. In addition to comparing between the Five-face pain scale and AI Emotion Detector mobile application in postoperative pain assessment.
Detailed description
The current study addresses an important gap in research, as the impact of sonic activation of irrigation on postoperative pain in children and the validity of artificial intelligence mobile application in detecting facial expressions following root canal treatment as not been well explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A comparative, randomized, prospective clinical trial to evaluate the efficacy of sonic activation versus no activation by comparing the pain scale and facial expressions following root canal treatment in primary molars.
| Arm | Type | Receives |
|---|---|---|
| Sonic activation of irrigation | Active comparator | Procedure: Root canal treatment in primary molars with irreversible pulpitis, Device: EDDY system for sonic activation of irrigationSonic activation of irrigation with Eddy system |
| No activation | Placebo comparator | Procedure: Root canal treatment in primary molars with irreversible pulpitis, Device: side-vented needleIrrigation with side-vented needle without activation |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children's age range 5-8 years. Boys and girls will be included.
- Children with positive or definitely positive behavior on the Frankl's behavior rating scale (rating 3 or 4 on the scale).
- Children with at least one primary molar with irreversible pulpitis and symptomatic apical periodontitis confirmed using periapical radiographs, percussion, and cold test.
- Children having teeth with two-thirds of each root remaining.
- Children with a moderate to very severe (2-4) pain score according to five-face pain scale in only one tooth within the 24-h period before the procedure.
Key exclusion criteria (3 listed)
- Teeth with pathological root resorption.
- Teeth with mobility greater than 1st-degree mobility.
- Children who received analgesics and/or antibiotics in the last 12 h before root canal treatment
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 |
|---|---|---|
| Root canal treatment in primary molars with irreversible pulpitisRoot canal treatment in primary molars with irreversible pulpitis followed by coronal restoration with stainless-steel crowns in a single visit. | Procedure or surgery | No activation, Sonic activation of irrigation |
| EDDY system for sonic activation of irrigationsonic activation of irrigation with EDDY system during root canal treatment in primary molars | Device | Sonic activation of irrigation |
| side-vented needleconventional irrigation with side-vented needle without activation during root canal treatment in primary molars | Device | No activation |
Primary outcome
Five-Face Pain Scale Score
Time frame: 8 ,24,48,72 hours, and after 1week post-operative
Postoperative pain is assessed using the Five-Face Pain Scale (range: 0 = no pain to 4= worst pain; lower scores indicate less pain). Unit of Measure: Scale units (0-4)
facial expressions analysis
Time frame: 8 ,24,48,72 hours, and after 1week post-operative
facial expressions of the patients are assessed from their photographs and analyzed by the AI Emotion Detector mobile application. Unit of Measure: Percentage (%)
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 12 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality restrictions.
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.
Ghada Abdelhamid El-Baz, Professor of Pedodontics study chair
Faculty of dentisrty, Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root canal treatment in primary molars with irreversible pulpitis, EDDY system for sonic activation of irrigation and side-vented needle in people with Root Canal Treatment in Children Primary Molars and Postoperative Pain, run by Suez Canal 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 6 inclusion and 3 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 12 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
Five-Face Pain Scale Score (time frame: 8 ,24,48,72 hours, and after 1week post-operative). 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 12 Sep 2025.