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NCT Number: NCT07427420

Postoperative Pain After Pulpectomy in Primary Molars

To compare the post operative pain in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation, through a Randomized Clinical Trial.

The main question it aims to answer is:

Is there a difference in post operative pain when using single rotary file system versus manual instrumentation in pulpectomy of primary molars?

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Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Endodontic procedures remain among the most commonly performed treatments following the diagnosis of pulpal inflammation or pathology. However, in primary teeth, endodontic treatment poses substantial difficulties owing to its complex anatomy and canal systems

  • Maintaining a primary tooth after successful root canal treatment is highly beneficial, as the preserved tooth serves as the most effective natural spacemaintainer
  • In cases of irreversible pulpitis, endodontic therapy remains the most common and frequently performed procedure to alleviate pain
  • Pulpectomy in primary molars is a critical treatment modality in pediatric dentistry when the pulp is irreversibly inflamed. Traditional instrumentation for pulpectomy often relies on manual files (e.g., stainless steel K-files), which can be time-consuming, technique sensitive, and may pose challenges due to the complex and delicate root anatomy of primary teeth
  • Rotary nickel-titanium (NiTi) systems have potential advantages: more efficient preparation, reduced chair-time, and possibly better patient cooperation. Indeed, study has found that rotary instrumentation significantly reduces both the instrumentation and obturation time and is associated with lower postoperative pain
  • Postoperative pain is one way to measure the success of endodontic treatment

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Patients:
  • Aged 4-6years, Medically free and Cooperative.
  • Teeth:
  • Restorable mandibular second primary molars with clinical signs or symptoms of irreversible pulpitis.

Pre-operative Radiographic criteria:

  • Absence of internal or external root resorption.
  • Absence of periapical or inter-radicular radiolucencies.

Exclusion criteria

  • • Patients:
  • Uncooperative children.
  • Children with systemic disease.
  • Physical or mental disabilities.
  • Refusal of participation.
  • Unable to attend follow- up visits.
  • Refusal to sign the informed consent.

Teeth:

  • Previously accessed teeth.
  • Mobile mandibular primary molars.
  • Pain on percussion.
  • Swelling in the vestibule or on palpation.

Treatment and study plan

Fanta AF F one rotary files 20 taper 4

Device

Fanta AF F one rotary files 20 taper 4 single rotary file system

Manual files (k files ,Mani, Inc., Japan).

Device

manual files (k files, Mani, Inc., Japan) size 15,20,25,30

Primary outcomes

  1. Post-operative pain

    Time frame: At 6, 12, 24, 48 and 72 hours and 1 week after Treatment

    : will be recorded by Asking the patient and/or guardian using a 4-point pain scale at 6, 12, 24, 48 and 72 hours And 1 week after treatment. The parent of each participant will receive 6 flashcards that include four faces and a word describing each face. 0 - None: No pain present.

    • - Mild: Pain is present but not distracting; easily ignored.
    • - Moderate: Pain is distracting; manageable but limits activities.
    • - Severe: Intense pain; unable to concentrate, requires immediate action or medication

Secondary outcomes

  1. child's behavior level

    Time frame: (Immediately after treatment)

    child's behavior level: will be recorded by using FRANKEL behavior rating Scale: rate 1 means definitely negative "refusal of treatment , fearfulness" rate 2 means negative "reluctance to accept treatment , uncooperative" rate 3 means positive "acceptance of treatment , patient follows the dentist's directions" rate 4 means definitely positive " good rapport with the dentist , laughter and enjoyment

  2. Clinical Success

    Time frame: ( At 3, 6, 12 months)

    • Absence of swelling will be recorded by visual examination
    • Absence of sinus or fistula: will be recorded by visual examination.
    • Pathologic mobility: will be recorded by mobility test (pressure using the end of two dental mirrors)
  3. Instrumentation time

    Time frame: (During procedure start from anathesia till end of procedure)

    will be recorded using a stopwatch

  4. The obturation quality

    Time frame: (Immediately after treatment)

    will be assessed using a radiograph(Using Coll and Sadrian criteria)

Study contacts

Contact information is provided by the study sponsor or research team.

Hanaa A Abd El Moniem, Phd

CONTACT

[email protected]

Mona A amer, Master

CONTACT

[email protected]

+201100877939

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Post Operative Pain Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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