CClinicalTrials.gg
Not yet recruitingNCT06524076Updated Aug 14, 2024

Evaluation of Success Rate of Partial Pulpotomy Versus Complete Pulpotomy in Primary Molars Using NeoPUTTY MTA

An interventional study of Partial Pulpotomy and Complete pulpotomy in Pulp Disease, Dental, sponsored by Cairo University. Not yet recruiting. Open to participants aged 4 Years to 7 Years. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
4 Years to 7 Years
Sex
All
01

Study summary

Evaluating the clinical and radiographic success of partial pulpotomy compared to complete pulpotomy in vital primary second molars with reversible pulpitis using NeoPUTTY™ (MTA).

Read the detailed description

Children with symptoms of reversible pulpitis in their second primary molar will be chosen to be enrolled in the study, and then randomly allocated into two groups. One group will undergo partial pulpotomy and the other group complete pulpotomy and followed up for 12 months. The blinding of the operator is not possible due to the nature of the technique used. Trial participants, outcome assessors and statistician will be blinded.

  1. Informed consent from participating children's parents.
  2. Baseline records photographs, percussion test, periapical radiograph and personal data collection.
  3. Diagnostic chart with personal, medical and dental history will be filled.
  4. Allocation (concealed by withdrawing a sealed opaque envelope containing Four-folded numbered papers containing the type of vital pulp therapy technique that will be used then writing the patient's name and I.D. on it and will be opened after removing the carious lesion).
  5. Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination).
  6. Preoperative and Postoperative photographs will be taken.
02

Conditions studied

  • Pulp Disease, Dental
03

In context

Dental Pulp Diseases

125 studies on the registry are indexed under Dental Pulp Diseases; 38 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 103 interventional studies indexed under Dental Pulp Diseases.

Browse Dental Pulp Diseases studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
4 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients:

    • Aged 4-7 years, in good general health and medically within normal.

Teeth:

  • Restorable mandibular second primary molars.
  • History of reversible pulpitis.

Preoperative radiograph:

  • Absence of periapical or inter-radicular radiolucency.
  • Absence of widening of periodontal ligaments (PDL) space.
  • Absence of internal or external root resorption.

Exclusion criteria

Exclusion Criteria:

  • Patients:

    • With systemic disorders.
    • Physical or mental disabilities.
    • Unable to attend follow-up visits.
    • Refusal of Participation.
    • Refusal to sign the informed consent.

Teeth:

  • Previously accessed teeth.
  • Mobile mandibular second primary molar.
  • Swelling in the vestibule or on palpation.
  • Pain on percussion.
05

Study design

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

Study arms

  • Experimental
    Partial Pulpotomy

    Procedure: Partial Pulpotomy

  • Active comparator
    Complete pulpotomy

    Procedure: Complete pulpotomy

Interventions

  • ProcedurePartial Pulpotomy

    After removing caries high-speed handpiece with water coolant using a round diamond bur. Once there is an exposure, the bur is changed with another sterile one with which the superficially inflamed pulp tissue will be gently removed to a depth of 1-3 mm beneath the pinpoint pulp exposure that occurred at the end of caries removal. A sterile cotton pellet with saline will be placed with light pressure for 2-3 minutes to achieve hemostasis.

  • ProcedureComplete pulpotomy

    After removing caries with a large round bur, the access cavity will be opened. Excavation of inflamed coronal pulp tissues will be done using a sharp excavator. A sterile cotton pellet with saline will be placed with light pressure for 2-3 minutes to achieve hemostasis.

06

What researchers measure

Primary outcomes

  1. Postoperative pain

    Postoperative pain assessment through Visual Analog Scale (the lower the value the better).

    Time frame: one week postoperative

  2. Swelling/ Fistula

    Assessment of swelling and fistula through visual examination.

    Time frame: 3, 6, 9, 12 months

  3. Mobility

    Assesment of pathological mobility using mobility test.

    Time frame: 3, 6, 9, 12 months

Secondary outcomes

  1. Radiographic success

    Radiographic evaluation (Radiolucency at furcation or periapical, internal or external root resorption) through visual interpretation of digital radiograph at 0, 6 and 12 months postoperatively.

    Time frame: 0, 6, 12 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06524076
Lead sponsor
Cairo University
Responsible party
Yara Ayman (Internal resident of Pediatric Dentistry and Public Health, Cairo University, Cairo University) — Principal investigator
First posted
Jul 29, 2024
Start date
Sep 22, 2024 (estimated)
Primary completion
Dec 22, 2024 (estimated)
Completion
Dec 22, 2025 (estimated)
Last update
Aug 14, 2024

Study contacts

Yara A. Badr, Masters
Contact
yara.badr@dentistry.cu.edu.eg
+201001151170
Hany M. Saber, PHD
study chair · Faculty of Dental Medicine, Cairo University
Hanaa M. Abd El Moniem, PHD
study director · Faculty of Dental Medicine, Cairo University
Yara A. Badr, Masters
principal investigator · Faculty of Dental Medicine, Cairo University

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 Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion