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Not yet recruitingNCT07046533Updated Jul 1, 2025

Evaluation of the Success Rate of Pulpotomy Versus to Root Canal Therapy in Management of Mature First Permanent Molars With Irreversible Pulpitis

An interventional study of (pulpotomy) and root canal treatment in Irreversible Pulpitis (Toothache) and Dental Caries (Diagnosis), sponsored by Lamiaa Saeed Ahmed Elshiekh. Not yet recruiting. Open to participants aged 9 Months to 14 Months. Per ClinicalTrials.gov, last updated 2025-07-01.

Sponsored by Lamiaa Saeed Ahmed Elshiekh · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
9 Months to 14 Months
Sex
All
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Study summary

The goal of This current study compare the clinical \& radiographic success rate between two different modalities conventional RCT and VPT using Bio-C-Repair as a pulp capping material to treat young patients with mature first permanent molars with irreversible pulpitis.

Read the detailed description

The teeth were anesthetized with 4% articaine with adrenaline 1/100,000 , isolated under rubber dam , and sterilized using a cotton pellet soaked in 2.5% sodium hypochlorite (NaOCl). Then carious leisons were removed by using a fresh sterile high-speed diamond bur under copious water irrigation. Upon pulp exposed, the cavity was rinsed with 2.5% NaOCl. The other steps of the treatment proceeded accordingly:

The procedure FP involved the removal of all coronal pulp tissue to the canals orifices level through a fresh sterile high-speed diamond bur Hemostasis was accomplished by compressing a cotton pellet soaked in 2.5% NaOCl over the radicular pulp tissue for 5 min. Then, irrigation with amount of sterile 0.9% sodium chloride (NaCl) solution was gently conducted. Once hemostasis was achieved, the radicular pulp tissue was observed as uniformly reddish pink color. Subsequently, a new type of premixed pulp-capping bio c repair ) was prepared according to the manufacturer's instructions, and a 4-mm layer was directly adapted over the radicular pulp tissue, ensuring that there was not any excess materials on the pulp chamber walls. The access cavity was restored with a liner)and composite restoration all completed in a single visit. Then postoperative radiographs were taken.

RCT was conducted in single visit the pulp tissues were removed from all the root canals, identifying and enlarging canal orifices via fanta Gold rotary , determing the working length with an apex locator. The root canals preparation was conducted by rotary nickel-titanium files, irrigated by using 2.5% NaOCl and 17% ethylenediaminetetraacetic acid (EDTA), and disinfected by using Ca(OH)2.

obturation was performed with gutta-percha and biocermaic sealer, using single cone technique.The access cavity was restored with a liner and resin composite restoration during the same appointment while using rubber dam isolation.

02

Conditions studied

  • Irreversible Pulpitis (Toothache)
  • Dental Caries (Diagnosis)

Keywords

  • randomized control trial
  • vital pulp therapy
03

In context

Toothache

142 studies on the registry are indexed under Toothache; 28 are open to participants now.

This study's planned enrollment of 60 is below the median of 84 across 123 interventional studies indexed under Toothache.

Browse Toothache studies →

Lead sponsor

This is the only study on the registry with Lamiaa Saeed Ahmed Elshiekh as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Months to 14 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Molars teeth with a history of spontaneous radiating pain indicated IP
  2. the pain triggered by hot/cold fluids lasted for several minutes after removing of the stimulus.
  3. Molars teeth with no prominent radiolucency at the periapical or furcation regions

Exclusion criteria

Exclusion Criteria:

  1. Teeth with continuous bleeding
  2. necrosis
  3. Teeth could not be restored with direct restoration. Teeth having localized/generalized periodontal diseases (probing pocket depth more than 3 mm).

Teeth with crack fracture. Teeth with internal/external root resorption. Teeth with pulp chamber/canal calcification

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    root canal treatment

    invasive technique depends on removal of all pulp tissue coronal and radicular and restore it with a gutta perch with bioceramic sealer

    Procedure: (pulpotomy) · Procedure: root canal treatment

  • Experimental
    pulpotomy

    non invasive technique depends on removal of only coronal pulp tissue and restore it with a new material bio c repair

    Procedure: (pulpotomy) · Procedure: root canal treatment

Interventions

  • Procedure(pulpotomy)

    non invasive technique depends on remove only the coronal pulp tissue instead of remove all pulp tissue

    Also known as: vital pulp therapy

  • Procedureroot canal treatment

    invasive technique depends on remove all radicular and coronal pulp tissue

06

What researchers measure

Primary outcomes

  1. success rate

    clinically and radiographically success rate according to success criteria

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2025; primary completion for Jul 2026, 12 months later.

Of 44 non-industry interventional studies with no phase under Toothache, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 12 months is above that.

Counting every sponsor, half of 45 studies reached it within 5 months; a quarter within 3 and three quarters within 12.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 13, 2025
First posted
Jul 1, 2025
StartEst.
Jul 1, 2025
Primary completionEst.
Jul 1, 2026
CompletionEst.
Jul 1, 2026
Last update
Jul 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07046533
Lead sponsor
Lamiaa Saeed Ahmed Elshiekh
Responsible party
Lamiaa Saeed Ahmed Elshiekh (Assistant Lecturer of Pediatric Dentistry, Faculty of Dentistry October 6th University, Cairo University) — Sponsor-investigator
First posted
Jul 1, 2025
Start date
Jul 1, 2025 (estimated)
Primary completion
Jul 1, 2026 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Jul 1, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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