Irreversible PulpitisNCT06748781
Clinical and Radiographic Evaluation of Calcium Hypochlorite Versus Saline As Root Canal Irrigants in Pulpectomy of Primary Molars: a Randomized Clinical Trial
A study testing Pulpectomy using 2.5% Calcium Hypochlorite root canal irrigant. and Pulpectomy using Saline as root canal irrigant in people with Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the clinical and radiographic success of Calcium Hypochlorite versus Saline as root canal irrigants in pulpectomy of primary molars. The research question it aims to answer is: In pulpectomy of primary molars will the use of calcium hypochlorite as root canal irrigant result in… Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Pulpectomy using 2.5% Calcium Hypochlorite root canal irrigant. and Pulpectomy using Saline as root canal irrigant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Apr 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 years and 7 years.
- Mandibular primary molars with deep caries lesion involving pulp.
- Mandibular primary molars that exhibit symptoms of irreversible pulpitis.
- Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.
- No history of swelling, fistula or sinus tract related to the offending molar.
Show all 10Show fewer
- Radiographic criteria:
- No sign of radiolucency in periapical or furcation area.
- No widening of PDL space or loss of lamina dura continuity.
- No evidence of internal/external pathologic root resorption.
Who cannot join
- Uncooperative children to avoid time waste and attrition bias.
- Children with systemic disease as some systemic diseases may have effect on the outcome (Segura-Egea et al., 2023).
- Lack of informed consent by the child patient's parent to be approved ethically.
- Unable to attend follow-up visits to avoid attrition bias by decreasing number of drop off cases.
- Refusal of participation as the parent of child has the authority of participation.
- Teeth near exfoliation time showing root resorption.
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
Cairo University Educational Dental Hospital
Cairo, Cairo Governorate
About this study
The aim of this study is to evaluate the clinical and radiographic success of Calcium Hypochlorite versus Saline as root canal irrigants in pulpectomy of primary molars.
The research question it aims to answer is:
In pulpectomy of primary molars will the use of calcium hypochlorite as root canal irrigant result in superior clinical and radiographic success to saline?
Read the detailed description
Dental caries is a progressive disease of the dental hard tissue that may lead to pulpal, periapical, and/or intraradicular infections if not managed in its initial stages. Treating caries in primary dentition is necessary to prevent the spread of bacteria, infection of the pulp, abscess, or facial cellulitis and to maintain tooth space.
The operator can choose the most appropriate treatment, including pulpotomy, pulpectomy, direct pulp capping, or indirect pulp capping, according to the child's signs and symptoms, pulp vitality, and radiographic evaluation.
Pulpectomy procedure involves the removal of the entire pulp tissue from the crown and root canals. Proper instrumentation, irrigation, and root canal obturation are all necessary for a successful pulpectomy. Root canal irrigants are essential for cleaning the root canal system, dissolving tissues, and removing the debris. Therefore, the choice of suitable root canal irrigant is important for the success of pulpectomy treatment.
Saline has been commonly used as a root canal irrigant for pulpectomy of primary molars with irreversible pulpitis; however, it only provides lubrication and cleaning actions without any tissue dissolving or disinfecting properties.
(Nelson-Filho et al., 2018) conducted a study to compare the bacterial contamination identified in the root canals of primary teeth with irreversible inflammatory pulpitis and in teeth showing apical periodontitis. The findings showed that there is almost always bacterial contamination of pulp tissue of primary teeth with irreversible pulpitis whenever the cause is carious pulp exposure.
In a study conducted by (Walia et al., 2019) four irrigation solutions (2% chlorhexidine, 1% NaOCl, saline, and laser irradiation) were compared. It was found that all three irrigation solutions, with the exception of saline, were successful in lowering the microbial count.
Compared to saline, Ca(OCl)2 has significant tissue dissolving and high antibacterial properties sufficient to ensure successful root canal pulpectomy.
It was demonstrated that the cytotoxicity of Ca(OCl) is time and dose-dependent manner. Another study by Blattes et al., 2017 illustrated that Ca(OCl)2 showed favorable results of cell viability and a low-level inflammatory response. Ca(OCl)2 showed acceptable cytotoxicity and biocompatibility as a root canal irrigant.
Rationale Calcium Hypochlorite (Ca(ClO)2) is used for water purification and has been suggested to be used in endodontics due to its capacity for tissue dissolution and its antimicrobial properties which is almost comparable to that of NaOCl and exhibit less cytotoxicity than NaOCl.
Up to our knowledge, no clinical trials in the literature have been done to compare the clinical and radiographic success of Calcium Hypochlorite versus Saline as root canal irrigant in pulpectomy of primary molars. Thus, the purpose of the present study is to investigate the clinical and radiographic success of these two materials.
- The benefits of this study to the participants:
- Better anti-microbial efficacy.
- Good tissue tolerance.
- The benefits of this study to the population:
Improving the quality of life for the patients by providing successful treatment with less post-operative complications.
•The benefits of this study to the clinicians:
- Providing a novel and alternative treatment option.
- Less post-operative complications.
- Simplicity in the preparation and less cost by obtaining a universal root canal irrigant that can manage all cases of primary teeth that need pulp therapy.
- Conditions
- Irreversible Pulpitis
- Being tested
- Pulpectomy using 2.5% Calcium Hypochlorite root canal irrigant., Pulpectomy using Saline as root canal irrigant
- Keywords
- calcium hypochlorite, irrigation, saline, irreversible pulpitis, calcium hydroxide with iodoform, primary molars, post operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulpectomy using 2.5% Calcium Hypochlorite root canal irrigant.Procedure or surgery
Also called 2.5% Ca(OCl)2 Pulpectomy
2.5% Calcium Hypochlorite used as root canal irrigant during the pulpectomy procedure in mandibular primary molars.
Pulpectomy using Saline as root canal irrigantProcedure or surgery
Also called Saline Pulpectomy
Saline used as root canal irrigant during the pulpectomy procedure in mandibular primary molars.
| Study group | Role | What they receive |
|---|---|---|
| • Pulpectomy using Calcium Hypochlorite 2.5% as root canal irrigant | Experimental | Pulpectomy using 2.5% Calcium Hypochlorite root canal irrigant Receives: Procedure: Pulpectomy using 2.5% Calcium Hypochlorite root canal irrigant. |
| • Pulpectomy using Saline as root canal irrigant | Active comparator | Pulpectomy using Saline as root canal irrigant. Receives: Procedure: Pulpectomy using Saline as root canal irrigant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of post-operative pain.
Asking the patient and/or guardian. Outcome measuring unit: Binary (Yes/No)
Measured: 1-week changes from baseline pulp condition
Secondary outcomes (6)
Absence of Swelling/Sinus or Fistula.
Visual clinical examination. Outcome measuring unit: Binary (yes/no)
Measured: at 3,6,9 and 12 months changes from the baseline pulp condition.
Absence of Pain to percussion
Percussion test using the back of a dental mirror. Outcome measuring unit :Binary (yes/no)
Measured: at 3,6,9 and 12 months changes from the baseline pulp condition.
Pathologic mobility
Mobility test (pressure using the end of two dental mirrors). Outcome measuring unit :Binary (yes/no)
Measured: at 3,6,9 and 12 months changes from the baseline pulp condition.
Absence of furcation or periapical radiolucency.
Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent)
Measured: at 6 and 12 months changes from the baseline pulp condition.
Absence of external or internal root resorption.
Intraoral digital periapical X-ray. Outcome measuring unit :Binary (yes/no)
Measured: at 6 and 12 months changes from the baseline pulp condition.
Widening of periodontal membrane space
Intraoral digital periapical X-ray. Outcome measuring unit :Binary (yes/no)
Measured: at 6 and 12 months changes from the baseline pulp condition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Abdo Helmy ElAssar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748781
- Sponsor's protocol ID
- Ca(OCl)2 Irrigation
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Calcium Hypochlorite Versus Saline As Root Canal Irrigants in Pulpectomy of Primary Molars: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06748781
- Acronym / sponsor ID
- Ca(OCl)2 Irrigation
- Conditions
- Irreversible Pulpitis
- Keywords
- calcium hypochlorite, irrigation, saline, irreversible pulpitis, calcium hydroxide with iodoform, primary molars, post operative pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 27 Dec 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.
The aim of this study is to evaluate the clinical and radiographic success of Calcium Hypochlorite versus Saline as root canal irrigants in pulpectomy of primary molars.
The research question it aims to answer is:
In pulpectomy of primary molars will the use of calcium hypochlorite as root canal irrigant result in superior clinical and radiographic success to saline?
Detailed description
Dental caries is a progressive disease of the dental hard tissue that may lead to pulpal, periapical, and/or intraradicular infections if not managed in its initial stages. Treating caries in primary dentition is necessary to prevent the spread of bacteria, infection of the pulp, abscess, or facial cellulitis and to maintain tooth space.
The operator can choose the most appropriate treatment, including pulpotomy, pulpectomy, direct pulp capping, or indirect pulp capping, according to the child's signs and symptoms, pulp vitality, and radiographic evaluation.
Pulpectomy procedure involves the removal of the entire pulp tissue from the crown and root canals. Proper instrumentation, irrigation, and root canal obturation are all necessary for a successful pulpectomy. Root canal irrigants are essential for cleaning the root canal system, dissolving tissues, and removing the debris. Therefore, the choice of suitable root canal irrigant is important for the success of pulpectomy treatment.
Saline has been commonly used as a root canal irrigant for pulpectomy of primary molars with irreversible pulpitis; however, it only provides lubrication and cleaning actions without any tissue dissolving or disinfecting properties.
(Nelson-Filho et al., 2018) conducted a study to compare the bacterial contamination identified in the root canals of primary teeth with irreversible inflammatory pulpitis and in teeth showing apical periodontitis. The findings showed that there is almost always bacterial contamination of pulp tissue of primary teeth with irreversible pulpitis whenever the cause is carious pulp exposure.
In a study conducted by (Walia et al., 2019) four irrigation solutions (2% chlorhexidine, 1% NaOCl, saline, and laser irradiation) were compared. It was found that all three irrigation solutions, with the exception of saline, were successful in lowering the microbial count.
Compared to saline, Ca(OCl)2 has significant tissue dissolving and high antibacterial properties sufficient to ensure successful root canal pulpectomy.
It was demonstrated that the cytotoxicity of Ca(OCl) is time and dose-dependent manner. Another study by Blattes et al., 2017 illustrated that Ca(OCl)2 showed favorable results of cell viability and a low-level inflammatory response. Ca(OCl)2 showed acceptable cytotoxicity and biocompatibility as a root canal irrigant.
Rationale Calcium Hypochlorite (Ca(ClO)2) is used for water purification and has been suggested to be used in endodontics due to its capacity for tissue dissolution and its antimicrobial properties which is almost comparable to that of NaOCl and exhibit less cytotoxicity than NaOCl.
Up to our knowledge, no clinical trials in the literature have been done to compare the clinical and radiographic success of Calcium Hypochlorite versus Saline as root canal irrigant in pulpectomy of primary molars. Thus, the purpose of the present study is to investigate the clinical and radiographic success of these two materials.
- The benefits of this study to the participants:
- Better anti-microbial efficacy.
- Good tissue tolerance.
- The benefits of this study to the population:
Improving the quality of life for the patients by providing successful treatment with less post-operative complications.
•The benefits of this study to the clinicians:
- Providing a novel and alternative treatment option.
- Less post-operative complications.
- Simplicity in the preparation and less cost by obtaining a universal root canal irrigant that can manage all cases of primary teeth that need pulp therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| • Pulpectomy using Calcium Hypochlorite 2.5% as root canal irrigant | Experimental | Procedure: Pulpectomy using 2.5% Calcium Hypochlorite root canal irrigant.Pulpectomy using 2.5% Calcium Hypochlorite root canal irrigant |
| • Pulpectomy using Saline as root canal irrigant | Active comparator | Procedure: Pulpectomy using Saline as root canal irrigantPulpectomy using Saline as root canal irrigant. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Clinical Criteria:
- Radiographic criteria:
Key exclusion criteria (6 listed)
- Uncooperative children to avoid time waste and attrition bias.
- Children with systemic disease as some systemic diseases may have effect on the outcome (Segura-Egea et al., 2023).
- Lack of informed consent by the child patient's parent to be approved ethically.
- Unable to attend follow-up visits to avoid attrition bias by decreasing number of drop off cases.
- Refusal of participation as the parent of child has the authority of participation.
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 |
|---|---|---|
| Pulpectomy using 2.5% Calcium Hypochlorite root canal irrigant.Also: 2.5% Ca(OCl)2 Pulpectomy2.5% Calcium Hypochlorite used as root canal irrigant during the pulpectomy procedure in mandibular primary molars. | Procedure or surgery | • Pulpectomy using Calcium Hypochlorite 2.5% as root canal irrigant |
| Pulpectomy using Saline as root canal irrigantAlso: Saline PulpectomySaline used as root canal irrigant during the pulpectomy procedure in mandibular primary molars. | Procedure or surgery | • Pulpectomy using Saline as root canal irrigant |
Primary outcome
Absence of post-operative pain.
Time frame: 1-week changes from baseline pulp condition
Asking the patient and/or guardian. Outcome measuring unit: Binary (Yes/No)
6 secondary outcomes
Absence of Swelling/Sinus or Fistula.
Time frame: at 3,6,9 and 12 months changes from the baseline pulp condition.
Absence of Pain to percussion
Time frame: at 3,6,9 and 12 months changes from the baseline pulp condition.
Pathologic mobility
Time frame: at 3,6,9 and 12 months changes from the baseline pulp condition.
Absence of furcation or periapical radiolucency.
Time frame: at 6 and 12 months changes from the baseline pulp condition.
Absence of external or internal root resorption.
Time frame: at 6 and 12 months changes from the baseline pulp condition.
Widening of periodontal membrane space
Time frame: at 6 and 12 months changes from the baseline pulp condition.
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 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulpectomy using 2.5% Calcium Hypochlorite root canal irrigant. and Pulpectomy using Saline as root canal irrigant in people with Irreversible Pulpitis, 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 10 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 27 Dec 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?
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 Yasmine Abdo Helmy ElAssar, BDS (0201023040204, yasmine.elasser@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of post-operative pain. (time frame: 1-week changes from baseline pulp condition). 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 27 Dec 2024.