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NCT Number: NCT06524076

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

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

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

  • Informed consent from participating children's parents.
  • Baseline records photographs, percussion test, periapical radiograph and personal data collection.
  • Diagnostic chart with personal, medical and dental history will be filled.
  • 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).
  • Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination).
  • Preoperative and Postoperative photographs will be taken.

Who can participate

Healthy volunteers accepted: No

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

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

  • 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.

Treatment and study plan

Partial pulpotomy

Procedure

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.

complete pulpotomy

Procedure

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.

Primary outcomes

  1. Postoperative pain

    Time frame: one week postoperative

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

  2. Swelling/ Fistula

    Time frame: 3, 6, 9, 12 months

    Assessment of swelling and fistula through visual examination.

  3. Mobility

    Time frame: 3, 6, 9, 12 months

    Assesment of pathological mobility using mobility test.

Secondary outcomes

  1. Radiographic success

    Time frame: 0, 6, 12 months

    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.

Study contacts

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

Yara A. Badr, Masters

CONTACT

[email protected]

+201001151170

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of Partial Pulpotomy Versus Complete Pulpotomy in Vital Pulp Therapy in Primary Molars Using NeoPUTTY™ (MTA): Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Aug 14, 2024

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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