PulpectomyNCT07319741
Clinical and Radiographic Outcomes of Rotary Instrumentation in Primary Molars
A study testing Rotary Instrumentation and Manual Instrumentation in people with Pulpectomy and Irreversible Pulpitis, run by Anfal mohamed elmotaz almogtaba at 1 site in Egypt.
Trial summary
This study will evaluate the clinical and radiographic outcomes of rotary versus manual pulpectomy in children with irreversible pulpitis.A single-visit pulpectomy will be performed for all patients. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Pulpectomy, Irreversible Pulpitis
- What is being tested?
- Rotary Instrumentation and Manual Instrumentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2026to Feb 2027
- 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
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-7 years with irreversible pulpitis of primary molars.
- History of spontaneous pain with a deep carious lesion.
- Parents who approve to write informed consent.
Who cannot join
- Medically compromised children.
- Children with a history of allergic reaction to the materials used in the study.
- Children with non-restorable teeth.
- Teeth with resorbed roots (more than two-thirds of root length).
- Extensive internal or external root resorption visible in periapical Radiographs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anfal Mohammed Almogtaba, Bechlor's degree in dentistry contact
About this study
Official title: Clinical and Radiographic Evaluation of Single Visit Pulpectomy in Primary Molars for (5-7) Years Old Children Using Rotary and Manual Instrumentation: A Randomized Clinical Trial
This study will evaluate the clinical and radiographic outcomes of rotary versus manual pulpectomy in children with irreversible pulpitis.A single-visit pulpectomy will be performed for all patients. Participants will be allocated to rotary instrumentation using Fanta AF Baby files or manual step-back instrumentation with K-files. Canals will be irrigated with 17% EDTA and 1% sodium hypochlorite, obturated with Metapex, and restored with glass ionomer cement and stainless-steel crowns. Primary outcomes will assess clinical success at 3, 6, 9, and 12 months, while secondary outcomes will evaluate postoperative pain and radiographic success at 6 and 12 months.
Read the detailed description
In this study, the principal investigator will screen participants to ensure eligibility and obtain comprehensive medical and dental histories from their parents or legal guardians, along with informed consent. All participants will undergo thorough clinical and radiographic examinations to confirm a diagnosis of irreversible pulpitis and suitability for pulpectomy. Local anesthesia will be administered, followed by caries removal, access cavity preparation, and pulpal extirpation. Working length will be determined radiographically, and participants will be allocated into two groups based on instrumentation technique: Group 1 will receive rotary instrumentation using Fanta AF Baby files with a crown-down approach, while Group 2 will undergo manual instrumentation using K-files with a step-back technique. Irrigation will involve 17% EDTA gel and 1% sodium hypochlorite, and canals will be obturated with Metapex, followed by restoration with glass ionomer cement and stainless-steel crowns in the same visit. The primary outcome will assess clinical success at 3, 6, 9, and 12 months post-treatment, defined by the absence of soft tissue swelling, tenderness, sinus tract, fistula, or pathological mobility. Secondary outcomes will include evaluation of postoperative pain intensity using a modified Wong-Baker Pain Rating Scale and radiographic success at 6 and 12 months, defined by the absence of root resorption, periodontal ligament widening, or periapical/furcal radiolucency.
- Conditions
- Pulpectomy, Irreversible Pulpitis
- Being tested
- Rotary Instrumentation, Manual Instrumentation
- Keywords
- Single visit pulpectomy, Rotary Instrumentation, Manual Instrumentation, Pain, swelling, radiographic outcomes
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotary InstrumentationProcedure or surgery
Single visit pulpectomy using rotary instrumentation
Manual InstrumentationProcedure or surgery
Single visit pulpectomy using manual instrumentation
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Single-Visit Pulpectomy using Rotary instrumentation | Active comparator | This group will include patients with irreversible pulpitis who will undergo single-visit pulpectomy using rotary instrumentation Receives: Procedure: Rotary Instrumentation |
| Group2: Single-visit pulpectomy using manual instrumentation | Active comparator | This group will include patients with irreversible pulpitis who will undergo single-visit pulpectomy using manual instrumentation Receives: Procedure: Manual Instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success of Pulpectomy procedure
The primary outcome of this study will be the assessment of clinical success of the both instrumentation techniques (Manual and Rotary instrumentation), evaluated at 3, 6, 9, and 12 months post-treatment. Clinical success will be defined based on binary assessment by the absence of soft tissue swelling, tenderness to percussion (Performed by the back of the mirror), sinus tract, fistula, and pathologic mobility
Measured: 12 months
Secondary outcomes (1)
Evaluation of Radiographic Success of Pulpectomy
Another secondary outcome of this study will be the radiographic evaluation of treatment after manual and rotary instrumentation based on binary assessment at 6 and 12 months postoperatively. Radiographic success will be defined as the absence of internal or external root resorption, loss of lamina dura integrity, periodontal ligament widening, or alveolar bone resorption in the periapical region. The presence of any of these findings or periapical/furcal radiolucency will be considered radiographic failure.
- Participant Timeline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpectomyStudies of the same condition, open and under way.
- 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
- Model description
- The study will include two groups with an allocation ratio of 1:1.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anfal mohamed elmotaz almogtaba
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Anfal mohamed elmotaz almogtaba, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319741
- Sponsor's protocol ID
- Rotary Files in Children
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Single Visit Pulpectomy in Primary Molars for (5-7) Years Old Children Using Rotary and Manual Instrumentation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07319741
- Acronym / sponsor ID
- Rotary Files in Children
- Conditions
- Pulpectomy, Irreversible Pulpitis
- Keywords
- Single visit pulpectomy, Rotary Instrumentation, Manual Instrumentation, Pain, swelling, radiographic outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Anfal mohamed elmotaz almogtabaUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 6 Jan 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 study will evaluate the clinical and radiographic outcomes of rotary versus manual pulpectomy in children with irreversible pulpitis.A single-visit pulpectomy will be performed for all patients. Participants will be allocated to rotary instrumentation using Fanta AF Baby files or manual step-back instrumentation with K-files. Canals will be irrigated with 17% EDTA and 1% sodium hypochlorite, obturated with Metapex, and restored with glass ionomer cement and stainless-steel crowns. Primary outcomes will assess clinical success at 3, 6, 9, and 12 months, while secondary outcomes will evaluate postoperative pain and radiographic success at 6 and 12 months.
Detailed description
In this study, the principal investigator will screen participants to ensure eligibility and obtain comprehensive medical and dental histories from their parents or legal guardians, along with informed consent. All participants will undergo thorough clinical and radiographic examinations to confirm a diagnosis of irreversible pulpitis and suitability for pulpectomy. Local anesthesia will be administered, followed by caries removal, access cavity preparation, and pulpal extirpation. Working length will be determined radiographically, and participants will be allocated into two groups based on instrumentation technique: Group 1 will receive rotary instrumentation using Fanta AF Baby files with a crown-down approach, while Group 2 will undergo manual instrumentation using K-files with a step-back technique. Irrigation will involve 17% EDTA gel and 1% sodium hypochlorite, and canals will be obturated with Metapex, followed by restoration with glass ionomer cement and stainless-steel crowns in the same visit. The primary outcome will assess clinical success at 3, 6, 9, and 12 months post-treatment, defined by the absence of soft tissue swelling, tenderness, sinus tract, fistula, or pathological mobility. Secondary outcomes will include evaluation of postoperative pain intensity using a modified Wong-Baker Pain Rating Scale and radiographic success at 6 and 12 months, defined by the absence of root resorption, periodontal ligament widening, or periapical/furcal radiolucency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will include two groups with an allocation ratio of 1:1.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Single-Visit Pulpectomy using Rotary instrumentation | Active comparator | Procedure: Rotary InstrumentationThis group will include patients with irreversible pulpitis who will undergo single-visit pulpectomy using rotary instrumentation |
| Group2: Single-visit pulpectomy using manual instrumentation | Active comparator | Procedure: Manual InstrumentationThis group will include patients with irreversible pulpitis who will undergo single-visit pulpectomy using manual instrumentation |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 5-7 years with irreversible pulpitis of primary molars.
- History of spontaneous pain with a deep carious lesion.
- Parents who approve to write informed consent.
Key exclusion criteria (5 listed)
- Medically compromised children.
- Children with a history of allergic reaction to the materials used in the study.
- Children with non-restorable teeth.
- Teeth with resorbed roots (more than two-thirds of root length).
- Extensive internal or external root resorption visible in periapical Radiographs.
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 |
|---|---|---|
| Rotary InstrumentationSingle visit pulpectomy using rotary instrumentation | Procedure or surgery | Group 1: Single-Visit Pulpectomy using Rotary instrumentation |
| Manual InstrumentationSingle visit pulpectomy using manual instrumentation | Procedure or surgery | Group2: Single-visit pulpectomy using manual instrumentation |
Primary outcome
Clinical success of Pulpectomy procedure
Time frame: 12 months
The primary outcome of this study will be the assessment of clinical success of the both instrumentation techniques (Manual and Rotary instrumentation), evaluated at 3, 6, 9, and 12 months post-treatment. Clinical success will be defined based on binary assessment by the absence of soft tissue swelling, tenderness to percussion (Performed by the back of the mirror), sinus tract, fistula, and pathologic mobility
1 secondary outcome
Evaluation of Radiographic Success of Pulpectomy
Time frame: 12 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 6 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Pulpectomy
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Clinical and Radiographic Evaluation of E-IodoCal in Primary Molar Pulpectomy
Pulpectomy, Pulpitis - Irreversible
Recruiting
Child's Behavior Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars
Irreversible Pulpitis
Active, not recruitingObservational study
Lesion Sterilization Tissue Repair and Conventional Pulpectomy in Primary Molars
Pulpitis - Irreversible, Pulp Necroses
RecruitingPhase 2
Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries
Deep Caries
Not yet recruiting
This Clinical Trial Aims to Compare the Effectiveness of Two Intra-pulpal Cryotherapy Techniques-Endo-ice and Ice Sticks-in Decreasing Intra-operative Pain and Enhancing the Success of Local Anesthesia During Pulpectomy of Mandibular Molars With Symptomatic Irreversible Pulpitis.
Root Canal Treatment, Intra-operative Pain
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.
Anfal Mohammed Almogtaba, Bechlor's degree in dentistry 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 Rotary Instrumentation and Manual Instrumentation in people with Pulpectomy and Irreversible Pulpitis, run by Anfal mohamed elmotaz almogtaba 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 3 inclusion and 5 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 6 Jan 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 Anfal Mohammed Almogtaba, Bechlor's degree in dentistry (+201125202599, anfal.mohamed@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 of Pulpectomy procedure (time frame: 12 months). 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 6 Jan 2026.