PulpectomyNCT07883200
Clinical and Radiographic Evaluation of E-IodoCal in Primary Molar Pulpectomy
A study testing E-IodoCal Root Canal Obturation (Group I) and Zinc Oxide-Eugenol Root Canal Obturation (Group II) in people with Pulpectomy and Pulpitis - Irreversible, run by Tanta University at 1 site in Egypt.
Trial summary
This randomized controlled split-mouth clinical trial evaluates the clinical and radiographic performance of E-IodoCal paste compared to zinc oxide-eugenol (ZOE) as root canal filling materials in primary molar pulpectomies. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Pulpectomy, Pulpitis - Irreversible, Zinc Oxide
- What is being tested?
- E-IodoCal Root Canal Obturation (Group I) and Zinc Oxide-Eugenol Root Canal Obturation (Group II)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2025to Dec 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical: -
- Healthy cooperative children with an age range of 4 - 8 years.
- Nonvital deep carious mandibular primary second molars with sufficient coronal structure and at least 2/3rd root structure intact.
- Pulp exposure where bleeding couldn't be stopped following removal of the coronal pulp tissue
- Previous history of irreversible pulpitis signs and symptoms as spontaneous pain, percussion sensitivity, fistulous tract related to the involved tooth, and pathologic tooth mobility (grade-I mobility)
- Radiographic:
- Adequate alveolar bone support (coverage by the bone of minimum two- thirds of at least one root).
- Presence of interradicular radiolucency (discontinuity of lamina dura and/or furcation involvement less than or equal to half of the shortest root).
Who cannot join
- Clinical:
- Non-restorable primary molars with severe mobility (greater than grade-I mobility).
- Children with systemic illness (any medically compromising condition).
- Primary molars beyond possible repair.
- Radiographic:
- Extensive internal resorption.
Show all 9Show fewer
- Extensive external pathological root resorption.
- Obliteration of the root canal.
- Physiological root resorption of more than a third of its length.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Mohammed Abd El-Galil El_Dowiek, master contact
Egypt1 site, 1 recruiting
- Recruiting
faculty of dentistry, Tanta university
Tanta
shaimaa eldesouky, assistant professor, 01008994242, shaimaaeldesouky@dent.tanta.edu.eg
About this study
Official title: Clinical and Radiographic Evaluation of E-IodoCal as Root Canal Filling Material in Primary Molars
This randomized controlled split-mouth clinical trial evaluates the clinical and radiographic performance of E-IodoCal paste compared to zinc oxide-eugenol (ZOE) as root canal filling materials in primary molar pulpectomies.
Read the detailed description
This randomized controlled split-mouth clinical trial evaluates the clinical and radiographic performance of E-IodoCal paste compared to zinc oxide-eugenol (ZOE) as root canal filling materials in primary molar pulpectomies. Sixty non-vital mandibular primary second molars from pediatric patients aged 4 to 8 years are randomly allocated into two equal groups (n=30 molars per group). Following standardized chemo-mechanical root canal preparation, canals are obturated with either E-IodoCal paste (Group I) or ZOE paste (Group II), and teeth are restored with stainless steel crowns. Clinical and radiographic success rates-evaluated via absence of pain, swelling, sinus tracts, pathological mobility, and periapical/interradicular radiolucencies-are assessed at 3, 6, and 9 months post-operative.
- Conditions
- Pulpectomy, Pulpitis - Irreversible, Zinc Oxide, Root Canal Obturation
- Being tested
- E-IodoCal Root Canal Obturation (Group I), Zinc Oxide-Eugenol Root Canal Obturation (Group II)
- Keywords
- E-IodoCal, Pulpectomy, Primary Teeth, Root Canal Filling Material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-IodoCal Root Canal Obturation (Group I)Procedure or surgery
Chemo-mechanical preparation: Rubber dam isolation, access opening, pulp tissue removal, working length determination, manual instrumentation up to #30-#35 using 17% EDTA gel lubricant, and standard irrigation with 2.5% sodium hypochlorite and normal saline. Canals are dried with sterile paper points.
Obturation: E-IodoCal paste delivered using its pre-packed polypropylene syringe inserted 1 mm short of the apex, withdrawing slowly as canals fill.
Restoration: Intermediate glass ionomer base (Medifil) followed by a final stainless steel crown.
Zinc Oxide-Eugenol Root Canal Obturation (Group II)Procedure or surgery
Preparation: Identical isolation, access, cleaning, shaping, and drying protocol as Group I.
Obturation: ZOE paste carried into canals in small increments using a hand plugger rotated counterclockwise until complete obturation is achieved.
Restoration: Identical glass ionomer base and final stainless steel crown placement.
| Study group | Role | What they receive |
|---|---|---|
| Group I - Experimental Group (E-IodoCal) | Experimental | Non-vital primary molars undergoing pulpectomy and obturated using pre-mixed E-IodoCal paste (calcium hydroxide, iodoform, and silicone oil). Receives: Procedure: E-IodoCal Root Canal Obturation (Group I) |
| Group II - Control Group (Zinc Oxide-Eugenol) | Active comparator | Non-vital primary molars undergoing pulpectomy and obturated using conventional Zinc Oxide-Eugenol (ZOE) paste. Receives: Procedure: Zinc Oxide-Eugenol Root Canal Obturation (Group II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Rate
Measure: Binary evaluation (Success/Failure) based on the complete absence of:
Spontaneous or stimulated pain.
Soft tissue swelling or draining sinus tract.
Pathological tooth mobility.
Tenderness to percussion / normal function on biting.
Measured: Evaluated at 3, 6, and 9 months post-operative.
Radiographic Success Rate
Measure: Binary evaluation (Success/Failure) assessed via standardized digital periapical radiographs based on:
Complete absence or reduction in size of periapical/interradicular radiolucency.
Absence of pathological root resorption (internal or external).
Normal, uniform, and unwidened periodontal ligament space with an intact, unbroken lamina dura.
Measured: Evaluated at 3, 6, and 9 months post-operative.
Secondary outcomes (2)
Overfill Clearance Rate
Proportion of teeth with extruded obturation material showing complete radiographic resorption of the overfilled paste beyond the anatomical apex without periapical tissue reaction (expressed as a binary percentage: Resorbed vs. Persistent).
Measured: At 3 months, 6 months, and 9 months post-operative.
Intracanal Material Resorption Rate
Radiographic evaluation of intracanal filling material stability categorized as: Harmonious (resorbing at the same rate as physiological root resorption), Premature (dissolving faster than root resorption leading to hollow-tube effect), or Retarded (not resorbing despite root resorption)
Measured: At 3 months, 6 months, and 9 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start25 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (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 PulpectomyStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shaban Mohamed El-desouky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883200
- Sponsor's protocol ID
- # PED-11-25-3496
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boutsiouki C, Frankenberger R, Kramer N. Clinical and radiographic success of (partial) pulpotomy and pulpectomy in primary teeth: A systematic review. Eur J Paediatr Dent. 2021 Dec;22(4):273-285. doi: 10.23804/ejpd.2021.22.04.4.
PubMed 35034465Reddy VV, Fernandes. Clinical and radiological evaluation of zinc oxide-eugenol and Maisto's paste as obturating materials in infected primary teeth--nine months study. J Indian Soc Pedod Prev Dent. 1996 Jun;14(2):39-44.
PubMed 9522755
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of E-IodoCal as Root Canal Filling Material in Primary Molars
- ClinicalTrials.gov ID
- NCT07883200
- Acronym / sponsor ID
- # PED-11-25-3496
- Conditions
- Pulpectomy, Pulpitis - Irreversible, Zinc Oxide, Root Canal Obturation
- Keywords
- E-IodoCal, Pulpectomy, Primary Teeth, Root Canal Filling Material
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Oct 2026 (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 randomized controlled split-mouth clinical trial evaluates the clinical and radiographic performance of E-IodoCal paste compared to zinc oxide-eugenol (ZOE) as root canal filling materials in primary molar pulpectomies.
Detailed description
This randomized controlled split-mouth clinical trial evaluates the clinical and radiographic performance of E-IodoCal paste compared to zinc oxide-eugenol (ZOE) as root canal filling materials in primary molar pulpectomies. Sixty non-vital mandibular primary second molars from pediatric patients aged 4 to 8 years are randomly allocated into two equal groups (n=30 molars per group). Following standardized chemo-mechanical root canal preparation, canals are obturated with either E-IodoCal paste (Group I) or ZOE paste (Group II), and teeth are restored with stainless steel crowns. Clinical and radiographic success rates-evaluated via absence of pain, swelling, sinus tracts, pathological mobility, and periapical/interradicular radiolucencies-are assessed at 3, 6, and 9 months post-operative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I - Experimental Group (E-IodoCal) | Experimental | Procedure: E-IodoCal Root Canal Obturation (Group I)Non-vital primary molars undergoing pulpectomy and obturated using pre-mixed E-IodoCal paste (calcium hydroxide, iodoform, and silicone oil). |
| Group II - Control Group (Zinc Oxide-Eugenol) | Active comparator | Procedure: Zinc Oxide-Eugenol Root Canal Obturation (Group II)Non-vital primary molars undergoing pulpectomy and obturated using conventional Zinc Oxide-Eugenol (ZOE) paste. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Clinical: -
- Healthy cooperative children with an age range of 4 - 8 years.
- Nonvital deep carious mandibular primary second molars with sufficient coronal structure and at least 2/3rd root structure intact.
- Pulp exposure where bleeding couldn't be stopped following removal of the coronal pulp tissue
- Previous history of irreversible pulpitis signs and symptoms as spontaneous pain, percussion sensitivity, fistulous tract related to the involved tooth, and pathologic tooth mobility (grade-I mobility)
Key exclusion criteria (9 listed)
- Non-restorable primary molars with severe mobility (greater than grade-I mobility).
- Children with systemic illness (any medically compromising condition).
- Primary molars beyond possible repair.
- Extensive internal resorption.
- Extensive external pathological root resorption.
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 |
|---|---|---|
| E-IodoCal Root Canal Obturation (Group I)Chemo-mechanical preparation: Rubber dam isolation, access opening, pulp tissue removal, working length determination, manual instrumentation up to #30-#35 using 17% EDTA gel lubricant, and standard irrigation with 2.5% sodium hypochlorite and normal saline. Canals are dried with sterile paper points. Obturation: E-IodoCal paste delivered using its pre-packed polypropylene syringe inserted 1 mm short of the apex, withdrawing slowly as canals fill. Restoration: Intermediate glass ionomer base (Medifil) followed by a final stainless steel crown. | Procedure or surgery | Group I - Experimental Group (E-IodoCal) |
| Zinc Oxide-Eugenol Root Canal Obturation (Group II)Preparation: Identical isolation, access, cleaning, shaping, and drying protocol as Group I. Obturation: ZOE paste carried into canals in small increments using a hand plugger rotated counterclockwise until complete obturation is achieved. Restoration: Identical glass ionomer base and final stainless steel crown placement. | Procedure or surgery | Group II - Control Group (Zinc Oxide-Eugenol) |
Primary outcome
Clinical Success Rate
Time frame: Evaluated at 3, 6, and 9 months post-operative.
Measure: Binary evaluation (Success/Failure) based on the complete absence of: Spontaneous or stimulated pain. Soft tissue swelling or draining sinus tract. Pathological tooth mobility. Tenderness to percussion / normal function on biting.
Radiographic Success Rate
Time frame: Evaluated at 3, 6, and 9 months post-operative.
Measure: Binary evaluation (Success/Failure) assessed via standardized digital periapical radiographs based on: Complete absence or reduction in size of periapical/interradicular radiolucency. Absence of pathological root resorption (internal or external). Normal, uniform, and unwidened periodontal ligament space with an intact, unbroken lamina dura.
2 secondary outcomes
Overfill Clearance Rate
Time frame: At 3 months, 6 months, and 9 months post-operative.
Intracanal Material Resorption Rate
Time frame: At 3 months, 6 months, and 9 months post-operative
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 22 Oct 2026.
- Results publication: PubMed 35034465Boutsiouki C, Frankenberger R, Kramer N. Clinical and radiographic success of (partial) pulpotomy and pulpectomy in primary teeth: A systematic review. Eur J Paediatr Dent. 2021 Dec;22(4):273-285. doi: 10.23804/ejpd.2021.22.04.4.
- Results publication: PubMed 9522755Reddy VV, Fernandes. Clinical and radiological evaluation of zinc oxide-eugenol and Maisto's paste as obturating materials in infected primary teeth--nine months study. J Indian Soc Pedod Prev Dent. 1996 Jun;14(2):39-44.
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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.
Sarah Mohammed Abd El-Galil El_Dowiek, master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-IodoCal Root Canal Obturation (Group I) and Zinc Oxide-Eugenol Root Canal Obturation (Group II) in people with Pulpectomy and Pulpitis - Irreversible, run by Tanta 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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 shaimaa eldesouky, assistant professor (01008994242, shaimaaeldesouky@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success Rate (time frame: Evaluated at 3, 6, and 9 months 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?
On the ClinicalTrials.gov record for NCT07883200, 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 22 Oct 2026.