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NCT Number: NCT07437794

Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars

This randomized clinical trial aims to evaluate the clinical and radiographic success of NeoPutty MTA compared to formocresol in vital pulpotomy of mandibular primary molars in children aged 4 to 9 years. Participants will be randomly allocated into two groups (1:1) to receive pulpotomy using either NeoPutty MTA or formocresol, followed by restoration with stainless steel crowns. Clinical and radiographic outcomes will be assessed during follow-up visits.

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Key information

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

October university for modern sciences and arts

Giza, Giza Governorate, 12116, Egypt

Location contact

Ahmed Shawky

CONTACT

[email protected]

+201124465202

About this study

Pulpotomy is a commonly performed vital pulp therapy in pediatric dentistry. Formocresol has been widely used due to its high clinical success; however, concerns exist regarding its potential toxicity. NeoPutty MTA is a premixed bioceramic material introduced as an alternative pulpotomy agent with improved handling properties and bioactivity. This randomized parallel-group clinical trial will compare NeoPutty MTA versus formocresol in vital pulpotomy of mandibular primary molars. Children aged 4-9 years presenting with asymptomatic carious mandibular primary molars will be recruited from the Pediatric Dentistry Department, Faculty of Dentistry, MSA University. Eligible teeth will undergo standardized pulpotomy procedures, restoration with glass ionomer cement, and stainless steel crowns. Clinical and radiographic follow-up will be performed at scheduled intervals to evaluate success and failure outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Children with asymptomatic decayed primary mandibular molar(s).

  • Patient and parent showing cooperation and compliance.
  • Children 4-9 years old.
  • Vital carious primary(s) with complete root formation.
  • Asymptomatic teeth or without clinical symptoms of spontaneous pain.
  • No clinical evidence of pulp degeneration like the history of spontaneous or nocturnal pain, tenderness to percussion, pathologic tooth mobility, swelling, or fistulous tract.
  • Both genders will be included.
  • No radiographic evidence of pulp degeneration such as internal root resorption, external root resorption, or furcal radiolucency.
  • Presence of two thirds of the root.
  • Teeth that can be restored.
  • Children with prior parental consent.

Exclusion criteria

  • History of any systemic disease.
  • Hemostasis is not achieved within 5 minutes of pulp amputation, by direct contact with a wet cotton pellet before the material placement.
  • The remaining radicular tissue was non-vital (with suppuration or purulence necrosis).

Treatment and study plan

NeoPutty MTA

Drug

NeoPutty MTA (NuSmile) will be placed directly over the radicular pulp stumps after hemostasis, then the tooth will be sealed with resin-modified glass ionomer cement and restored with stainless steel crown.

Formocresol

Drug

A sterile cotton pellet lightly moistened with a 1:5 dilution of Buckley's formocresol will be placed against the pulp stumps for 3-5 minutes, then removed. Reinforced zinc oxide eugenol will be placed, followed by glass ionomer cement and stainless steel crown restoration.

Primary outcomes

  1. Postoperative pain

    Time frame: 1 week postoperatively, 3 months, 6 months, 9 months and 12 months

    Presence or absence of spontaneous postoperative pain reported by the child/parent after pulpotomy treatment.

Secondary outcomes

  1. Pain on percussion

    Time frame: 3 months, 6 months, 9 months and 12 months

    Description: Presence or absence of pain on percussion during clinical follow-up visits.

  2. Presence of sinus tract, fistula or abscess

    Time frame: 3 months, 6 months, 9 months and 12 months

    Description: Clinical evaluation for presence of swelling, abscess, or sinus/fistulous tract related to the treated tooth.

  3. Tooth mobility

    Time frame: 3 months, 6 months, 9 months and 12 months

    Description: Tooth mobility assessed clinically using a mobility scoring system ranges from 0-3 were (score 0 the best) indicates no mobility and (score 3 the worst) indicates vertical and horizontal mobility.

  4. Widening of Periodontal Ligament Space

    Time frame: 6 months and 12 months after treatment

    Radiographic evidence of widening of the periodontal ligament space assessed using standardized periapical radiographs. Recorded as Present / Absent.

  5. Internal and External Root Resorption

    Time frame: 6 months and 12 months after treatment

    Radiographic evidence of internal or external root resorption observed on periapical radiographs. Recorded as Present / Absent.

  6. Furcal or Periapical Radiolucency

    Time frame: 6 months and 12 months after treatment

    Presence of radiolucent lesion in the furcation or periapical area detected on standardized periapical radiographs. Recorded as Present / Absent.

Study contacts

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

Ahmed Shawky, bachelor of dentistry

CONTACT

[email protected]

+201124465202

Sponsors and collaborators

Lead sponsor

October University for Modern Sciences and Arts

Other

Registry information

Official study title

Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars: A Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 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.