Pulpectomy AgentsNCT07025525
Clinical and Radiographic Evaluation of Ultrasonic Activated Irrigation Versus Non Activated Irrigation in Pulpectomy of Necrotic Primary Molars : A Randomized Clinical Trial
A study testing Ultrasonic activated sodium hypochlorite, Ultrasonic acivated saline and Sodium Hypochlorite Solution in people with Pulpectomy Agents, run by Cairo University at 1 site in Egypt.
Trial summary
This is a Clinical and Radiographic Evaluation of Canal Irrigation Using Ultrasonically Activated vs. Non-Activated Irrigants in Pulpectomy of Necrotic Primary Molars: A Randomized Clinical Trial" This study aims to compare the effectiveness of using ultrasonically activated irrigant versus non-activated irrigant in… Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Pulpectomy Agents
- What is being tested?
- Ultrasonic activated sodium hypochlorite, Ultrasonic acivated saline and Sodium Hypochlorite Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -
- Clinical Criteria:
- Children aged between 4 to 7 years' old
- Children with deep caries involving pulp in primary molars
- History of abscess, swelling or pus
- Pain on percussion
Show all 11Show fewer
- Mobility grade 1
- Radiographic criteria:
- Root resorption due to abscess less that ⅔ of root
- Periapical RL or furcation RL
- Widening in PDL space or loss of lamina dura continuity
Who cannot join
- Clinical criteria: -
- Refusal of participation.
- Patient unable to attend to follow up
- Non-restorable tooth.
- Medically compromised patient.
- Uncooperative patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of dentistry cairo university
Cairo
Rasha Mohamed Rasha Hatem Associate Professor, 02 0100 1670222, rasha.hatem@dentistry.cu.edu.eg
About this study
This is a Clinical and Radiographic Evaluation of Canal Irrigation Using Ultrasonically Activated vs. Non-Activated Irrigants in Pulpectomy of Necrotic Primary Molars: A Randomized Clinical Trial" This study aims to compare the effectiveness of using ultrasonically activated irrigant versus non-activated irrigant in terms of clinical and radiographic success rates in the pulpectomy of necrotic primary molars, through a randomized clinical trial.
Read the detailed description
Primary teeth are considered of great importance to children allowing their normal, healthy development and growth while preserving function, eating, speech and normal development of occlusion while preserving the space for permanent dentition and guide their eruption.
Pulpectomy of primary molar teeth is considered as reasonable treatment approach to ensure either normal shedding or long term survival of 1ry teeth as fully functional component in dental arch.
Treatment of necrotic primary teeth is complex due to anatomical and physiological characteristics and high no. of bacterial species present in endodontic infection.
Treatment success depend on the elimination of root canal infection which can be done mechanically and chemically to ensure the complete removal of bacterial canal infection.
Irrigation is a key part of successful root canal treatment. It has several important functions, the most important one that it has a washing effect and an antimicrobial/antibiofilm effect. Irrigation is also the only way to impact those areas of the root canal wall not touched by mechanical instrumentation.
Ultrasonic activation cause irrigant streaming and cavitation phenomena resulting in significantly improved debridement of canal spaces, disruption of biofilm and improved penetration of irrigant into dentinal tubules and reduces bacterial level improving prognosis and ability to seal.
This study has been conducted by only few researchers, and there is limited evidence supporting the effect of ultrasonic activation on irrigation.
So this study is conducted to compare the effect of ultrasonic activation of irrigation on success of pulpectomy versus that of non-activated irrigation
- Conditions
- Pulpectomy Agents
- Being tested
- Ultrasonic activated sodium hypochlorite, Ultrasonic acivated saline, Sodium Hypochlorite Solution, Saline
- Keywords
- Primary molars, Irrigation activation within the canal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic activated sodium hypochloriteDevice
Using ultrasonic-activated sodium hypochlorite in the canals of primary molars can significantly enhance root canal disinfection by improving the irrigant's penetration and effectiveness. Primary molars often have complex and irregular canal anatomies, which can limit the reach of traditional irrigation methods. Ultrasonic activation creates acoustic streaming and cavitation effects, allowing sodium hypochlorite to better dissolve organic tissue and disrupt bacterial biofilms, especially in hard-to-reach areas. This leads to more thorough cleaning, reduced microbial load, and potentially better clinical outcomes in pediatric endodontics
Ultrasonic acivated salineOther
using ultrasonic-activated saline within the canals of primary teeth lies in its ability to enhance mechanical debridement and improve irrigation effectiveness without the risks associated with stronger chemical agents. Although saline lacks inherent antimicrobial properties, ultrasonic activation generates acoustic streaming and cavitation, which help dislodge debris, disrupt biofilms, and clean intricate canal anatomy more efficiently than passive irrigation. This makes it a safer alternative in pediatric patients, minimizing the risk of cytotoxic effects or damage to developing permanent tooth buds while still improving cleaning outcomes.
Sodium Hypochlorite SolutionOther
using sodium hypochlorite (NaOCl) within the canals of primary molars is its excellent antimicrobial and tissue-dissolving properties, which are essential for effective root canal disinfection. Primary molars often have complex and irregular canal systems that harbor bacteria and necrotic tissue. Sodium hypochlorite not only helps eliminate a broad spectrum of microorganisms but also dissolves organic debris, improving canal cleanliness and reducing the risk of post-treatment infection. When used in appropriate concentrations, it can significantly enhance the success of pulpectomy procedures in pediatric patients while maintaining safety.
SalineOther
Saline is commonly used as an irrigant in the root canal treatment of primary molars due to its excellent biocompatibility and safety profile. It is a non-toxic, isotonic solution that poses no risk to the surrounding periapical tissues, which is particularly important in primary teeth where root resorption and open apices are common. This minimizes the chance of damaging the underlying permanent tooth germ, a critical consideration in pediatric dentistry. Saline is also safe if accidentally extruded beyond the apex or ingested, making it a suitable choice for young children.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1 | Experimental | Ultrasonic activated sodium hypochlorite Receives: Device: Ultrasonic activated sodium hypochlorite |
| Intervention group 2 | Experimental | Ultrasonic activated saline Receives: Other: Ultrasonic acivated saline |
| Intervention group 3 | Experimental | Sodium hypochlorite Receives: Other: Sodium Hypochlorite Solution |
| Control group 4 | Active comparator | Saline Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Post operative pain assessments will be clinically , binary yes or no oral from patients word
Measured: 6 months
Soft tissue pathology
This outcome will be measured clinically , binary yes or no by visual inspection
Measured: 6 months
Pain on percussion
Will measured clinically , binary yes or no using back of mirror for percussion assessment
Measured: 6 months
Pathological mobility
Will be assessed clinically , binary by yes or no using back of mirror and finger of one hand to check mobility
Measured: 6 months
Secondary outcomes (2)
Furcation or periapical pathology
Will be measured clinically by periapical radiograph binary yes or no the presence of Radiolucency
Measured: 6 months
External or internal root resorption
Will be assessed by radiograph binary yes or no checking radiolucency
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study startAug 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulpectomy AgentsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naira Essam Farouk, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025525
- Sponsor's protocol ID
- dentistry Cairo university
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Singh R, Barua P, Kumar M, Safaya R, Monajemi H, Monajemi H. Effect of Ultrasonic Instrumentation in Treatment of Primary Molars. J Contemp Dent Pract. 2017 Sep 1;18(9):750-753. doi: 10.5005/jp-journals-10024-2120.
PubMed 28874635Virdee SS, Seymour DW, Farnell D, Bhamra G, Bhakta S. Efficacy of irrigant activation techniques in removing intracanal smear layer and debris from mature permanent teeth: a systematic review and meta-analysis. Int Endod J. 2018 Jun;51(6):605-621. doi: 10.1111/iej.12877. Epub 2017 Dec 22.
PubMed 29178166Kumar RS, Ankola AV, Sankeshwari RM, Hebbal M, Hampiholi V, Kumar S L, Deshpande AP, Choudhury AR, Pai Khot AJ. Effectiveness of various irrigant activation techniques on the penetration of sodium hypochlorite into lateral canals of mature permanent teeth: A systematic review and meta-analysis. Saudi Dent J. 2023 Jan;35(1):1-23. doi: 10.1016/j.sdentj.2022.12.004. Epub 2022 Dec 16.
PubMed 36817024Ahmed, H.M.A., 2014. Pulpectomy procedures in primary molar teeth. European Journal of General Dentistry, 3(01), pp.3-10
Fabris AS, Nakano V, Avila-Campos MJ. Bacteriological analysis of necrotic pulp and fistulae in primary teeth. J Appl Oral Sci. 2014 Apr;22(2):118-24. doi: 10.1590/1678-775720130358.
PubMed 24676582
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Ultrasonic Activated Irrigation Versus Non Activated Irrigation in Pulpectomy of Necrotic Primary Molars : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07025525
- Acronym / sponsor ID
- dentistry Cairo university
- Conditions
- Pulpectomy Agents
- Keywords
- Primary molars, Irrigation activation within the canal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 17 Jun 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 is a Clinical and Radiographic Evaluation of Canal Irrigation Using Ultrasonically Activated vs. Non-Activated Irrigants in Pulpectomy of Necrotic Primary Molars: A Randomized Clinical Trial" This study aims to compare the effectiveness of using ultrasonically activated irrigant versus non-activated irrigant in terms of clinical and radiographic success rates in the pulpectomy of necrotic primary molars, through a randomized clinical trial.
Detailed description
Primary teeth are considered of great importance to children allowing their normal, healthy development and growth while preserving function, eating, speech and normal development of occlusion while preserving the space for permanent dentition and guide their eruption.
Pulpectomy of primary molar teeth is considered as reasonable treatment approach to ensure either normal shedding or long term survival of 1ry teeth as fully functional component in dental arch.
Treatment of necrotic primary teeth is complex due to anatomical and physiological characteristics and high no. of bacterial species present in endodontic infection.
Treatment success depend on the elimination of root canal infection which can be done mechanically and chemically to ensure the complete removal of bacterial canal infection.
Irrigation is a key part of successful root canal treatment. It has several important functions, the most important one that it has a washing effect and an antimicrobial/antibiofilm effect. Irrigation is also the only way to impact those areas of the root canal wall not touched by mechanical instrumentation.
Ultrasonic activation cause irrigant streaming and cavitation phenomena resulting in significantly improved debridement of canal spaces, disruption of biofilm and improved penetration of irrigant into dentinal tubules and reduces bacterial level improving prognosis and ability to seal.
This study has been conducted by only few researchers, and there is limited evidence supporting the effect of ultrasonic activation on irrigation.
So this study is conducted to compare the effect of ultrasonic activation of irrigation on success of pulpectomy versus that of non-activated irrigation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1 | Experimental | Device: Ultrasonic activated sodium hypochloriteUltrasonic activated sodium hypochlorite |
| Intervention group 2 | Experimental | Other: Ultrasonic acivated salineUltrasonic activated saline |
| Intervention group 3 | Experimental | Other: Sodium Hypochlorite SolutionSodium hypochlorite |
| Control group 4 | Active comparator | Other: SalineSaline |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- -
- Children aged between 4 to 7 years' old
- Children with deep caries involving pulp in primary molars
- History of abscess, swelling or pus
- Pain on percussion
Key exclusion criteria (6 listed)
- Clinical criteria: -
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 |
|---|---|---|
| Ultrasonic activated sodium hypochloriteUsing ultrasonic-activated sodium hypochlorite in the canals of primary molars can significantly enhance root canal disinfection by improving the irrigant's penetration and effectiveness. Primary molars often have complex and irregular canal anatomies, which can limit the reach of traditional irrigation methods. Ultrasonic activation creates acoustic streaming and cavitation effects, allowing sodium hypochlorite to better dissolve organic tissue and disrupt bacterial biofilms, especially in hard-to-reach areas. This leads to more thorough cleaning, reduced microbial load, and potentially better clinical outcomes in pediatric endodontics | Device | Intervention group 1 |
| Ultrasonic acivated salineusing ultrasonic-activated saline within the canals of primary teeth lies in its ability to enhance mechanical debridement and improve irrigation effectiveness without the risks associated with stronger chemical agents. Although saline lacks inherent antimicrobial properties, ultrasonic activation generates acoustic streaming and cavitation, which help dislodge debris, disrupt biofilms, and clean intricate canal anatomy more efficiently than passive irrigation. This makes it a safer alternative in pediatric patients, minimizing the risk of cytotoxic effects or damage to developing permanent tooth buds while still improving cleaning outcomes. | Other | Intervention group 2 |
| Sodium Hypochlorite Solutionusing sodium hypochlorite (NaOCl) within the canals of primary molars is its excellent antimicrobial and tissue-dissolving properties, which are essential for effective root canal disinfection. Primary molars often have complex and irregular canal systems that harbor bacteria and necrotic tissue. Sodium hypochlorite not only helps eliminate a broad spectrum of microorganisms but also dissolves organic debris, improving canal cleanliness and reducing the risk of post-treatment infection. When used in appropriate concentrations, it can significantly enhance the success of pulpectomy procedures in pediatric patients while maintaining safety. | Other | Intervention group 3 |
| SalineSaline is commonly used as an irrigant in the root canal treatment of primary molars due to its excellent biocompatibility and safety profile. It is a non-toxic, isotonic solution that poses no risk to the surrounding periapical tissues, which is particularly important in primary teeth where root resorption and open apices are common. This minimizes the chance of damaging the underlying permanent tooth germ, a critical consideration in pediatric dentistry. Saline is also safe if accidentally extruded beyond the apex or ingested, making it a suitable choice for young children. | Other | Control group 4 |
Primary outcome
Post operative pain
Time frame: 6 months
Post operative pain assessments will be clinically , binary yes or no oral from patients word
Soft tissue pathology
Time frame: 6 months
This outcome will be measured clinically , binary yes or no by visual inspection
Pain on percussion
Time frame: 6 months
Will measured clinically , binary yes or no using back of mirror for percussion assessment
Pathological mobility
Time frame: 6 months
Will be assessed clinically , binary by yes or no using back of mirror and finger of one hand to check mobility
2 secondary outcomes
Furcation or periapical pathology
Time frame: 6 months
External or internal root resorption
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Background: PubMed 28874635Singh R, Barua P, Kumar M, Safaya R, Monajemi H, Monajemi H. Effect of Ultrasonic Instrumentation in Treatment of Primary Molars. J Contemp Dent Pract. 2017 Sep 1;18(9):750-753. doi: 10.5005/jp-journals-10024-2120.
- Background: PubMed 29178166Virdee SS, Seymour DW, Farnell D, Bhamra G, Bhakta S. Efficacy of irrigant activation techniques in removing intracanal smear layer and debris from mature permanent teeth: a systematic review and meta-analysis. Int Endod J. 2018 Jun;51(6):605-621. doi: 10.1111/iej.12877. Epub 2017 Dec 22.
- Background: PubMed 36817024Kumar RS, Ankola AV, Sankeshwari RM, Hebbal M, Hampiholi V, Kumar S L, Deshpande AP, Choudhury AR, Pai Khot AJ. Effectiveness of various irrigant activation techniques on the penetration of sodium hypochlorite into lateral canals of mature permanent teeth: A systematic review and meta-analysis. Saudi Dent J. 2023 Jan;35(1):1-23. doi: 10.1016/j.sdentj.2022.12.004. Epub 2022 Dec 16.
- BackgroundAhmed, H.M.A., 2014. Pulpectomy procedures in primary molar teeth. European Journal of General Dentistry, 3(01), pp.3-10
- Background: PubMed 24676582Fabris AS, Nakano V, Avila-Campos MJ. Bacteriological analysis of necrotic pulp and fistulae in primary teeth. J Appl Oral Sci. 2014 Apr;22(2):118-24. doi: 10.1590/1678-775720130358.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic activated sodium hypochlorite, Ultrasonic acivated saline and Sodium Hypochlorite Solution in people with Pulpectomy Agents, run by Cairo 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 11 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Jun 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naira Essam Naira Essam resident intern (0201018567752, nayera.farouk@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: 6 months). The study lists 4 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 NCT07025525, which also lists 5 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 17 Jun 2025.