Carious Primary MolarsNCT07090252
Comparison of ZOE vs ZON in Primary Mandibular Molars Pulpectomy of 5-7-Year-Olds
A study testing Group I zinc oxide Neem and Group II zinc oxide eugenol in people with Carious Primary Molars, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluation of Zinc oxide-eugenol compared to Zinc oxide with Neem as obturating materials in primary mandibular molars pulpectomy for 5-7 Year-Old Children.The main question(s)it aim to answer : Could the clinical and radiographic success of a mixture of zinc oxide with Neem oil… Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Primary Molars
- What is being tested?
- Group I zinc oxide Neem and Group II zinc oxide eugenol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 1 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 5-7 years with infected primary molars.
- Deep carious lesion.
- History of spontaneous pain
- Parent written informed consent.
Who cannot join
- Medically compromised children
- Children with a history of allergic reaction to the components of the tested material
- Children who had non restorable teeth
- Teeth with less than two third of root length
- Extensive internal or external root resorption
- Unable to attend follow-up visits
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 Faculty of Dentistry
Cairo, El-manial, 3387722
Cairo University Faculty of Dentistry, 0020223642705, rec@dentistry.cu.edu.eg
About this study
Official title: Clinical and Radiographic Evaluation of Zinc Oxide-eugenol and Zinc Oxide With Neem as Obturating Materials in Primary Mandibular Molars Pulpectomy for 5-7 Year-Old Children: A Randomized Clinical Trail
The goal of this clinical trial is to evaluation of Zinc oxide-eugenol compared to Zinc oxide with Neem as obturating materials in primary mandibular molars pulpectomy for 5-7 Year-Old Children.The main question(s)it aim to answer : Could the clinical and radiographic success of a mixture of zinc oxide with Neem oil be comparable with Zinc oxide-eugenol paste in pulpectomy of primary mandibular molars?
Read the detailed description
Dental caries is a global public health issue that mostly affects children in their early childhood, negatively impacting both their oral and overall health .The primary teeth with pulpal and periapical problems, should be kept until their natural exfoliation because their early loss could result in undesired abnormalities in the dentition later on . The complex root canal morphology, intrinsic physiologic root resorption, close proximity to the permanent successors, difficulty obtaining good radiographic views of the tooth apices, complex diagnosis due to the patient's immaturity, requirement for behavioral guidance of pediatric patients, technique selection, and root filling material selection make pulpectomy in primary teeth still controversial .When the pulp becomes irreversibly infected or necrotic, root canal therapy is recommended for children. The most common root canal filling material for primary teeth is zinc oxide eugenol (ZOE). However, it has some drawbacks, including slow resorption, periapical tissue irritation, and bone and cementum necrosis, which can result in anterior cross bite, palatal eruption, or ectopic eruption of a succedaneous tooth. As a result, ongoing research is required to find the ideal obturation material.To ensure the success of the endodontic treatment, various materials with good antimicrobial properties are used as root canal filling materials in primary teeth Phytodentistry has become a growing field in dentistry. It refers to the use of medicinal plants and their products to treat disease, either directly or indirectly. ZOE has been attempted with a variety of chemicals to improve its characteristics and success rate, however neither the success rate nor the material's resorbability were improved when compared to ZOE alone.Eugenol irritates the periapical area and solidifies into hard mass when combined with ZnO powder. Neem belongs to the family Meliaceae, also known as Azadirachta indica, is a plant that originated in India and now thrives in tropical and subtropical regions worldwide. It is highly valued for its therapeutic benefits. Neem contains a variety of biologically active compounds, including alkaloids, flavonoids, triterpenoids, phenolic compounds, carotenoids, steroids, and ketones. It has strong antimicrobial properties that can help manage and prevent various infections.This can aid in pharmacovigilance by monitoring and managing antibiotic and antimicrobial side effects. It has many medical uses such as immunoregulatory, antifungal, antihyperglycemic, antiulcer, antimalarial, anti inflammatory, antibacterial, antiviral, and antioxidant
- Conditions
- Carious Primary Molars
- Being tested
- Group I zinc oxide Neem, Group II zinc oxide eugenol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I zinc oxide NeemOther
preperation: 1\ A standardized access cavity procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove coronal pulpal tissues then will remove radicular pulp by barbed broach then will be used K files for chemo mechanical preparation (size 15,20,25) with saline (2%) irrigation to remove necrotic pulp tissues then all the canals will be dried using paper points. 2\ After complete excavation of all pulp tissue, saline irrigation is done then the canals will be obturated zinc-oxide with Neem ( Zinc oxide powder(Prime Dental Pvt. Ltd.Thane, Maharashtra, India) and 100% Neem oil with mixing ratio of 1:3 will be mixed on a glass slab with a stainless- steel spatula) and then the rest of the pulp chamber will be filled with Zinconol. (reinforced zinc oxide eugenol)3\ Tooth will be restored with stainless steel crown.
Group II zinc oxide eugenolOther
preperation: 1\ A standardized access cavity procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove coronal pulpal tissues then will remove radicular pulp by barbed broach then will be used K files for chemo mechanical preparation (size 15,20,25) with saline (2%) irrigation to remove necrotic pulp tissues then all the canals will be dried using paper points 2\ After complete removed of coronal and radicular pulp zinc oxide eugenol will be manipulated in the ratio of 3:1 (powder: liquid) to obtain semisolid mix.This mix will be placed in the canals. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by the application of Zinconol.3\ Tooth will be restored with stainless steel crown.
| Study group | Role | What they receive |
|---|---|---|
| Group I zinc oxide with Neem | Experimental | Neem and zinc oxide powder have been improved as a theraputic agents with high antibacterial, antioxidant, and enzyme-inhibiting properties against microorganisms resistant to antibiotics.Neem contains many chemically diverse and structurally complex phytochemicals, such as limonoids, flavonoids, phenols, catechins, gallic acid,polyphenols, and nimbins which contribute to their different pharmacological activities. Receives: Other: Group I zinc oxide Neem |
| Group II zinc oxide -eugenol | Experimental | zinc oxide eugenol is a mixture of zinc oxide (powder) and eugenol (liquid). Zinc oxide and eugenol (ZOE) paste is a standard in dentistry among the pastes used in the pulp therapy of primary teeth. Receives: Other: Group II zinc oxide eugenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
- Absence of pain method of measurement: verbal question to patient/parent Outcome measuring unit: Binary(Yes/No)
- Absence of tenderness to percussion method of measurement: percussion test by the back of the dental mirror Outcome measuring unit: Binary(Yes/No)
- Absence of swelling and sinus tract method of measurement: Visual and Clinical examination Outcome measuring unit: Binary(Yes/No)
- Absence of mobility: method of measurement: Mobility test by using two single-ended instruments(dental mirror and probe) Outcome measuring unit: Binary(Yes/No)
Measured: [Time Frame: follow-up: T(Time):12months interval T0:0 T1:3month T2:6month T3:9month T4:12month]
Secondary outcomes (1)
Radiographic Success
- Absence or reduction in the size of periapical radiolucency Method of measurement: Visual interpretation for intra-oral periapical radiograph Outcome measuring unit: Binary(Yes/No)
- Absence or reduction in the size of furcation radiolucency Method of measurement: Visual interpretation for Intra-oral periapical radiograph Outcome measuring unit: Binary(Yes/No)
Measured: [Time Frame: follow-up: T(Time):12months interval T0:0 T2:6month T4:12month]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious Primary MolarsStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Ali Osman Ali, Cairo University
- Investigators
- Adel Elbardissy, Prof Doctor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090252
- Sponsor's protocol ID
- CRP-ZOE Vs ZON
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Zinc Oxide-eugenol and Zinc Oxide With Neem as Obturating Materials in Primary Mandibular Molars Pulpectomy for 5-7 Year-Old Children: A Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT07090252
- Acronym / sponsor ID
- CRP-ZOE Vs ZON
- Conditions
- Carious Primary Molars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 29 Jul 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.
The goal of this clinical trial is to evaluation of Zinc oxide-eugenol compared to Zinc oxide with Neem as obturating materials in primary mandibular molars pulpectomy for 5-7 Year-Old Children.The main question(s)it aim to answer : Could the clinical and radiographic success of a mixture of zinc oxide with Neem oil be comparable with Zinc oxide-eugenol paste in pulpectomy of primary mandibular molars?
Detailed description
Dental caries is a global public health issue that mostly affects children in their early childhood, negatively impacting both their oral and overall health .The primary teeth with pulpal and periapical problems, should be kept until their natural exfoliation because their early loss could result in undesired abnormalities in the dentition later on . The complex root canal morphology, intrinsic physiologic root resorption, close proximity to the permanent successors, difficulty obtaining good radiographic views of the tooth apices, complex diagnosis due to the patient's immaturity, requirement for behavioral guidance of pediatric patients, technique selection, and root filling material selection make pulpectomy in primary teeth still controversial .When the pulp becomes irreversibly infected or necrotic, root canal therapy is recommended for children. The most common root canal filling material for primary teeth is zinc oxide eugenol (ZOE). However, it has some drawbacks, including slow resorption, periapical tissue irritation, and bone and cementum necrosis, which can result in anterior cross bite, palatal eruption, or ectopic eruption of a succedaneous tooth. As a result, ongoing research is required to find the ideal obturation material.To ensure the success of the endodontic treatment, various materials with good antimicrobial properties are used as root canal filling materials in primary teeth Phytodentistry has become a growing field in dentistry. It refers to the use of medicinal plants and their products to treat disease, either directly or indirectly. ZOE has been attempted with a variety of chemicals to improve its characteristics and success rate, however neither the success rate nor the material's resorbability were improved when compared to ZOE alone.Eugenol irritates the periapical area and solidifies into hard mass when combined with ZnO powder. Neem belongs to the family Meliaceae, also known as Azadirachta indica, is a plant that originated in India and now thrives in tropical and subtropical regions worldwide. It is highly valued for its therapeutic benefits. Neem contains a variety of biologically active compounds, including alkaloids, flavonoids, triterpenoids, phenolic compounds, carotenoids, steroids, and ketones. It has strong antimicrobial properties that can help manage and prevent various infections.This can aid in pharmacovigilance by monitoring and managing antibiotic and antimicrobial side effects. It has many medical uses such as immunoregulatory, antifungal, antihyperglycemic, antiulcer, antimalarial, anti inflammatory, antibacterial, antiviral, and antioxidant
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 zinc oxide with Neem | Experimental | Other: Group I zinc oxide NeemNeem and zinc oxide powder have been improved as a theraputic agents with high antibacterial, antioxidant, and enzyme-inhibiting properties against microorganisms resistant to antibiotics.Neem contains many chemically diverse and structurally complex phytochemicals, such as limonoids, flavonoids, phenols, catechins, gallic acid,polyphenols, and nimbins which contribute to their different pharmacological activities. |
| Group II zinc oxide -eugenol | Experimental | Other: Group II zinc oxide eugenolzinc oxide eugenol is a mixture of zinc oxide (powder) and eugenol (liquid). Zinc oxide and eugenol (ZOE) paste is a standard in dentistry among the pastes used in the pulp therapy of primary teeth. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 5-7 years with infected primary molars.
- Deep carious lesion.
- History of spontaneous pain
- Parent written informed consent.
Key exclusion criteria (6 listed)
- Medically compromised children
- Children with a history of allergic reaction to the components of the tested material
- Children who had non restorable teeth
- Teeth with less than two third of root length
- Extensive internal or external 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 |
|---|---|---|
| Group I zinc oxide Neempreperation: 1\ A standardized access cavity procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove coronal pulpal tissues then will remove radicular pulp by barbed broach then will be used K files for chemo mechanical preparation (size 15,20,25) with saline (2%) irrigation to remove necrotic pulp tissues then all the canals will be dried using paper points. 2\ After complete excavation of all pulp tissue, saline irrigation is done then the canals will be obturated zinc-oxide with Neem ( Zinc oxide powder(Prime Dental Pvt. Ltd.Thane, Maharashtra, India) and 100% Neem oil with mixing ratio of 1:3 will be mixed on a glass slab with a stainless- steel spatula) and then the rest of the pulp chamber will be filled with Zinconol. (reinforced zinc oxide eugenol)3\ Tooth will be restored with stainless steel crown. | Other | Group I zinc oxide with Neem |
| Group II zinc oxide eugenolpreperation: 1\ A standardized access cavity procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove coronal pulpal tissues then will remove radicular pulp by barbed broach then will be used K files for chemo mechanical preparation (size 15,20,25) with saline (2%) irrigation to remove necrotic pulp tissues then all the canals will be dried using paper points 2\ After complete removed of coronal and radicular pulp zinc oxide eugenol will be manipulated in the ratio of 3:1 (powder: liquid) to obtain semisolid mix.This mix will be placed in the canals. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by the application of Zinconol.3\ Tooth will be restored with stainless steel crown. | Other | Group II zinc oxide -eugenol |
Primary outcome
Clinical Success
Time frame: [Time Frame: follow-up: T(Time):12months interval T0:0 T1:3month T2:6month T3:9month T4:12month]
1. Absence of pain method of measurement: verbal question to patient/parent Outcome measuring unit: Binary(Yes/No) 2. Absence of tenderness to percussion method of measurement: percussion test by the back of the dental mirror Outcome measuring unit: Binary(Yes/No) 3. Absence of swelling and sinus tract method of measurement: Visual and Clinical examination Outcome measuring unit: Binary(Yes/No) 4. Absence of mobility: method of measurement: Mobility test by using two single-ended instruments(dental mirror and probe) Outcome measuring unit: Binary(Yes/No)
1 secondary outcome
Radiographic Success
Time frame: [Time Frame: follow-up: T(Time):12months interval T0:0 T2:6month T4:12month]
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 1 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Carious Primary Molars
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical and Radiographic Comparison of SMART Hall and Conventional Hall Techniques in Children With Carious Primary Molars
Clinical Effect
Not yet recruiting
Oxymetazoline Versus Sodium Hypochlorite as Hemostatic Agents in MTA Pulpotomy of Primary Molars
Pulp Disease, Dental, Pulp Therapy in Primary Molars
Recruiting
A Study Comparing the Hall Technique and Conventional Stainless-Steel Crowns in Carious Primary Molars : Clinical Outcomes, Anxiety, Time, and Cost-Effectiveness
Hall Technique
Not yet recruiting
Pain Perception of Novel Chemo-mechanical Caries Remove Versus Atraumatic Restorative Treatment Method in Primary Molars
Carious Primary Molars
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.
Adel Elbardissy, Prof Doctor study director
Cairo 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 Group I zinc oxide Neem and Group II zinc oxide eugenol in people with Carious Primary Molars, 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 4 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 1 Aug 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 Tasneem Ali Osman Ali, Master degree (+201151360396, tasneem.ali@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success (time frame: [Time Frame: follow-up: T(Time):12months interval T0:0 T1:3month T2:6month T3:9month T4:12month]). 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 1 Aug 2025.