Pulpitis - IrreversibleNCT05336682
Evaluation of Lesion Sterilization and Tissue Repair Techniques Versus Pulpectomy in Primary Molars With Inflammed Pulp
A study testing Lesion Sterilization and Tissue Repair with radicular instrumentation, Lesion Sterilization and Tissue Repair without radicular instrumentation and Conventional pulpectomy in people with Pulpitis - Irreversible, run by Cairo University at 1 site in Egypt.
Trial summary
Group I (Experimental group I): Lesion Sterilization and Tissue Repair with radicular instrumentation. Coronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and canals. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Lesion Sterilization and Tissue Repair with radicular instrumentation, Lesion Sterilization and Tissue Repair without radicular instrumentation and Conventional pulpectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2022to 30 May 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Molars should be restorable.
- Mandibular second primary molars with deep caries, vital carious pulp exposure, irreversible pulpitis.
- Mobility: Non or grade I.
- Radiographic signs of minimal external root resorption.
Who cannot join
- Children with known allergy to the agents used.
- Children with infective endocarditis.
- Refusal of participation.
- Unable to attend follow-up visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Lesion Sterilization and Tissue Repair Techniques Versus Conventional Pulpectomy in Primary Molars With Inflammed Pulp A Randomized Clinical Trial
Group I (Experimental group I): Lesion Sterilization and Tissue Repair with radicular instrumentation.
Coronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and canals.
Read more
Group II (Experimental group II): Lesion Sterilization and Tissue Repair with no radicular instrumentation.
Only the coronal pulp is removed, the pulpal floor is covered with triple antibiotic paste with propylene glycol mix.
Group III (Control group): Conventional pulpectomy. Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of Zinc oxide and eugenol.
Read the detailed description
The principal investigator will carry out all treatment procedures, and the patients will be assigned into three groups.
For the three interventions "Two test arms and one control group":
- Diagnostic chart with personal, medical and dental history will be filled.
- Clinical examination will be performed to assess the clinical inclusion criteria.
- Preoperative radiographs will be taken to assess the inclusion criteria. Preoperative radiograph will serve as a reference for the follow-up radiographs.
- Informed consent is taken from participating parents, and they are asked to attend follow-up meetings every 3 month or whenever there is any symptom.
- Baseline records (personal data collection, photographs, percussion test and preoperative periapical radiographs).
- Allocation (concealed by withdrawing a sealed opaque envelope containing eight times folded paper containing the intervention that will be used then writing patient name and I.D. on it and will be opened after performing the access cavity).
- Administration of Ibuprofen in age-dosage volume before administration of local anesthesia by 30 minutes to decrease pulpal pain, pain of injection and post-operative pain.
- Administration of local anesthesia at the side of the affected molar.
- Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation followed by irrigation with 2% Chlorhexidine gluconate. Ethylenediaminetetraacetic acid "EDTA" will be used to remove the smear layer leading to clean and patented dentinal tubules.
- Children will then be allocated into either one of the groups alternatively depending on the technique of intervention by opening a closed white envelope that is drawn for the patient.
Preparation of triple antibiotic paste:
The commercially available antibiotics are taken in separate dappen dishes. The enteric coating of the tablet is removed by scraping the coating with a blade, and for the capsule the outer capsular material is removed. Then each of the components is powdered separately with a clean mortar and pestle. Care should be taken to avoid wetting of powder. At this stage, the powder can be stored separately in tightly capped containers in a dark place or in the refrigerator to prevent exposure to light and moisture. After proper pulverization, each of the components is taken in a clean glass slab/mixing pad. Then a part of propylene glycol as a solvent is dispensed and mixed with equal parts of antibiotics powder to ensure uniform consistency of the mix. The final preparation will be a soft ball-like structure of 1 mm diameter. Resultant opaque paste has to be stored in airtight containers. If the mix turns translucent on storage, it has to be discarded.
Group I (Experimental group I): LSTR with radicular instrumentation. Coronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and canals.
Group II (Experimental group II): LSTR with no radicular instrumentation. Only the coronal pulp is removed, the pulpal floor is covered with triple antibiotic paste with propylene glycol mix.
Group III (Control group): Conventional pulpectomy. Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of ZOE.
For all groups:
- The molar is then restored with glass ionomer and stainless steel crown.
- Intraoral periapical radiographs are taken after completion of the procedure.
- The children are recalled for clinical evaluation at the interval of 3,6,9,12 months; and radiographic evaluation at 6,12 months.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Lesion Sterilization and Tissue Repair with radicular instrumentation, Lesion Sterilization and Tissue Repair without radicular instrumentation, Conventional pulpectomy
- Keywords
- LSTR, Lesion Sterilization and Tissue Repair, pulpectomy, zinc oxide and eugenol, irreversible pulpitis, vital, primary molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lesion Sterilization and Tissue Repair with radicular instrumentationProcedure or surgery
Coronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and the canals.
Lesion Sterilization and Tissue Repair without radicular instrumentationProcedure or surgery
Only the coronal pulp is removed, the pulpal floor is covered with triple antibiotic paste with propylene glycol mix.
Conventional pulpectomyProcedure or surgery
Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of ZOE.
| Study group | Role | What they receive |
|---|---|---|
| LSTR with radicular instrumentation. | Experimental | Not described Receives: Procedure: Lesion Sterilization and Tissue Repair with radicular instrumentation |
| LSTR with no radicular instrumentation. | Experimental | Not described Receives: Procedure: Lesion Sterilization and Tissue Repair without radicular instrumentation |
| Conventional pulpectomy. | Active comparator | Not described Receives: Procedure: Conventional pulpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success "binary"
Absence of • Spontaneous pain.
- Sensitivity to percussion using dental mirror, pain on biting.
- Swelling.
- Fistula / Exudate.
- Mobility.
Measured: 12 months
Radiographic success "binary"
Absence of • Absence of furcation or periapical radiolucency.
- Absence of change in the extent of internal or external root resorption other than physiologic resorption.
Measured: 12 months
Secondary outcomes (3)
Child cooperation
Continuous outcome measured on Frankl's scale immediately after the procedure.
Measured: Immediately after the intervention
Parental satisfaction
Binary outcome measured by direct questioning to parents. "Yes/No"
Measured: Immediately after the intervention
Chair side time
Continuous outcome measured in minutes using stopwatch. (After hemostasis is achieved, time will be measured with a stopwatch from the start of the three techniques till the final restoration is performed)
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start20 Sep 2022
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Hamed AbdElHameed Rabea, Cairo University
- Investigators
- Gihan M Abuelniel, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336682
- Sponsor's protocol ID
- 000
- Status last verified
- Feb 2026
- First submitted
- 7 Apr 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Lesion Sterilization and Tissue Repair Techniques Versus Conventional Pulpectomy in Primary Molars With Inflammed Pulp A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05336682
- Acronym / sponsor ID
- 000
- Conditions
- Pulpitis - Irreversible
- Keywords
- LSTR, Lesion Sterilization and Tissue Repair, pulpectomy, zinc oxide and eugenol, irreversible pulpitis, vital, primary molars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 20 Apr 2022 (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.
Group I (Experimental group I): Lesion Sterilization and Tissue Repair with radicular instrumentation.
Coronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and canals.
Group II (Experimental group II): Lesion Sterilization and Tissue Repair with no radicular instrumentation.
Only the coronal pulp is removed, the pulpal floor is covered with triple antibiotic paste with propylene glycol mix.
Group III (Control group): Conventional pulpectomy. Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of Zinc oxide and eugenol.
Detailed description
The principal investigator will carry out all treatment procedures, and the patients will be assigned into three groups.
For the three interventions "Two test arms and one control group":
- Diagnostic chart with personal, medical and dental history will be filled.
- Clinical examination will be performed to assess the clinical inclusion criteria.
- Preoperative radiographs will be taken to assess the inclusion criteria. Preoperative radiograph will serve as a reference for the follow-up radiographs.
- Informed consent is taken from participating parents, and they are asked to attend follow-up meetings every 3 month or whenever there is any symptom.
- Baseline records (personal data collection, photographs, percussion test and preoperative periapical radiographs).
- Allocation (concealed by withdrawing a sealed opaque envelope containing eight times folded paper containing the intervention that will be used then writing patient name and I.D. on it and will be opened after performing the access cavity).
- Administration of Ibuprofen in age-dosage volume before administration of local anesthesia by 30 minutes to decrease pulpal pain, pain of injection and post-operative pain.
- Administration of local anesthesia at the side of the affected molar.
- Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation followed by irrigation with 2% Chlorhexidine gluconate. Ethylenediaminetetraacetic acid "EDTA" will be used to remove the smear layer leading to clean and patented dentinal tubules.
- Children will then be allocated into either one of the groups alternatively depending on the technique of intervention by opening a closed white envelope that is drawn for the patient.
Preparation of triple antibiotic paste:
The commercially available antibiotics are taken in separate dappen dishes. The enteric coating of the tablet is removed by scraping the coating with a blade, and for the capsule the outer capsular material is removed. Then each of the components is powdered separately with a clean mortar and pestle. Care should be taken to avoid wetting of powder. At this stage, the powder can be stored separately in tightly capped containers in a dark place or in the refrigerator to prevent exposure to light and moisture. After proper pulverization, each of the components is taken in a clean glass slab/mixing pad. Then a part of propylene glycol as a solvent is dispensed and mixed with equal parts of antibiotics powder to ensure uniform consistency of the mix. The final preparation will be a soft ball-like structure of 1 mm diameter. Resultant opaque paste has to be stored in airtight containers. If the mix turns translucent on storage, it has to be discarded.
Group I (Experimental group I): LSTR with radicular instrumentation. Coronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and canals.
Group II (Experimental group II): LSTR with no radicular instrumentation. Only the coronal pulp is removed, the pulpal floor is covered with triple antibiotic paste with propylene glycol mix.
Group III (Control group): Conventional pulpectomy. Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of ZOE.
For all groups:
- The molar is then restored with glass ionomer and stainless steel crown.
- Intraoral periapical radiographs are taken after completion of the procedure.
- The children are recalled for clinical evaluation at the interval of 3,6,9,12 months; and radiographic evaluation at 6,12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LSTR with radicular instrumentation. | Experimental | Procedure: Lesion Sterilization and Tissue Repair with radicular instrumentation |
| LSTR with no radicular instrumentation. | Experimental | Procedure: Lesion Sterilization and Tissue Repair without radicular instrumentation |
| Conventional pulpectomy. | Active comparator | Procedure: Conventional pulpectomy |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Molars should be restorable.
- Mandibular second primary molars with deep caries, vital carious pulp exposure, irreversible pulpitis.
- Mobility: Non or grade I.
- Radiographic signs of minimal external root resorption.
Key exclusion criteria (4 listed)
- Children with known allergy to the agents used.
- Children with infective endocarditis.
- Refusal of participation.
- Unable to attend follow-up visits.
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 |
|---|---|---|
| Lesion Sterilization and Tissue Repair with radicular instrumentationCoronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and the canals. | Procedure or surgery | LSTR with radicular instrumentation. |
| Lesion Sterilization and Tissue Repair without radicular instrumentationOnly the coronal pulp is removed, the pulpal floor is covered with triple antibiotic paste with propylene glycol mix. | Procedure or surgery | LSTR with no radicular instrumentation. |
| Conventional pulpectomyPulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of ZOE. | Procedure or surgery | Conventional pulpectomy. |
Primary outcome
Clinical success "binary"
Time frame: 12 months
Absence of • Spontaneous pain. * Sensitivity to percussion using dental mirror, pain on biting. * Swelling. * Fistula / Exudate. * Mobility.
Radiographic success "binary"
Time frame: 12 months
Absence of • Absence of furcation or periapical radiolucency. • Absence of change in the extent of internal or external root resorption other than physiologic resorption.
3 secondary outcomes
Child cooperation
Time frame: Immediately after the intervention
Parental satisfaction
Time frame: Immediately after the intervention
Chair side time
Time frame: Immediately after the intervention
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 27 Feb 2026.
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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. This study is not recruiting at the moment.
Gihan M Abuelniel, Professor study chair
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 Lesion Sterilization and Tissue Repair with radicular instrumentation, Lesion Sterilization and Tissue Repair without radicular instrumentation and Conventional pulpectomy in people with Pulpitis - Irreversible, 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 4 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 27 Feb 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?
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?
Clinical success "binary" (time frame: 12 months). 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 27 Feb 2026.