Skip to main content
OpenTrials
Completed

NCT Number: NCT07769697

Comparative Clinical and Radiographic Evaluation of Different Pulpotomy Materials in Primary Molars

This randomized clinical trial compared the clinical and radiographic outcomes of ferric sulfate (FS), mineral trioxide aggregate (MTA), calcium-enriched mixture (CEM), and TheraCal PT used for pulpotomy in primary molars. A total of 140 restorable primary molars from children aged 4 to 9 years were randomly allocated to four treatment groups. Clinical and radiographic evaluations were performed at 3, 6, 9, and 12 months to compare treatment success and failure among the four pulpotomy materials.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dental Caries Dental Pulp Diseases Dental Pulp Exposure Primary Molar Pulpotomy Primary Teeth Pulp Exposure, Dental Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Battalgazi, Malatya, Turkey (Türkiye)

About this study

Vital pulpotomy is a well-established treatment for preserving the vitality of primary molars with carious pulp exposure when the radicular pulp is considered healthy. Several pulpotomy materials have been proposed, including ferric sulfate (FS), mineral trioxide aggregate (MTA), calcium-enriched mixture (CEM), and TheraCal PT. Although FS, MTA, and CEM have been extensively investigated, clinical evidence regarding the performance of TheraCal PT in primary molar pulpotomy remains limited.

This study was designed as a single-center, parallel-group, randomized controlled clinical trial to compare the clinical and radiographic outcomes of FS, MTA, CEM, and TheraCal PT used for pulpotomy in primary molars. A total of 140 restorable primary molars from children aged 4 to 9 years were randomly allocated to one of four treatment groups. Following pulpotomy, all teeth were restored according to the study protocol and evaluated clinically and radiographically at 3, 6, 9, and 12 months.

The primary outcome measure was the 12-month clinical and radiographic success of pulpotomy. Secondary outcomes included treatment failure patterns and the influence of tooth type, arch, and restoration type on treatment success.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient-related criteria

  • Children aged 4-9 years.
  • Healthy children with no systemic disease.
  • No regular medication use.
  • No known allergy to the study materials.
  • Cooperative patients able to undergo dental treatment.
  • Written informed consent obtained from the parent or legal guardian. Tooth-related criteria
  • Restorable primary molars with deep carious lesions requiring pulpotomy.
  • Clinical signs and symptoms consistent with reversible pulpitis (no spontaneous, lingering, or nocturnal pain).
  • No tenderness to percussion or pathological mobility.
  • No swelling or sinus tract associated with the study tooth.
  • Hemostasis achieved within 5 minutes after coronal pulp amputation.
  • No radiographic evidence of internal or external root resorption, furcation or periapical radiolucency, periodontal ligament widening, or pulp calcification.
  • At least two-thirds of the root length remaining.

Exclusion criteria

  • Failure to meet any of the inclusion criteria.
  • No pulp exposure or pulp exposure ≤1 mm after complete caries removal.
  • Persistent pain during caries removal despite adequate local anesthesia, suggestive of advanced pulpal inflammation.
  • Excessive pulpal bleeding that could not be controlled within 5 minutes.
  • Presence of purulent exudate from the pulp.
  • Loss of patient cooperation during treatment.
  • Withdrawal of parental consent or inability to attend follow-up visits.

Treatment and study plan

Pulpotomy

Procedure

Pulpotomy is a vital pulp therapy procedure in which the coronal pulp tissue is removed while preserving the vitality of the radicular pulp. Following hemostasis, the assigned pulpotomy material was applied according to the study protocol before definitive restoration of the tooth.

Mineral Trioxide Aggregate (MTA)

Other

Mineral trioxide aggregate (MTA) was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.

Calcium-Enriched Mixture (CEM)

Other

Calcium-enriched mixture (CEM) was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.

Ferric Sulfate

Other

Ferric sulfate was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.

TheraCal PT

Other

TheraCal PT was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.

Primary outcomes

  1. Rate of clinical success at 12 months

    Time frame: 12 months

    Clinical success was defined as the absence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars meeting all clinical success criteria at the 12-month follow-up.

  2. Rate of radiographic success at 12 months

    Time frame: 12 months

    Radiographic success was defined as the absence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars meeting all radiographic success criteria at the 12-month follow-up.

Secondary outcomes

  1. Rate of clinical success at 3 months

    Time frame: 3 months

    Clinical success was defined as the absence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars meeting all clinical success criteria at the 3-month follow-up.

  2. Rate of clinical success at 6 months

    Time frame: 6 months

    Clinical success was defined as the absence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars meeting all clinical success criteria at the 6-month follow-up.

  3. Rate of clinical success at 9 months

    Time frame: 9 months

    Clinical success was defined as the absence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars meeting all clinical success criteria at the 9-month follow-up.

  4. Rate of radiographic success at 3 months

    Time frame: 3 months

    Radiographic success was defined as the absence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars meeting all radiographic success criteria at the 3-month follow-up.

  5. Rate of radiographic success at 6 months

    Time frame: 6 months

    Radiographic success was defined as the absence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars meeting all radiographic success criteria at the 6-month follow-up.

  6. Rate of radiographic success at 9 months

    Time frame: 9 months

    Radiographic success was defined as the absence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars meeting all radiographic success criteria at the 9-month follow-up.

  7. Rate of clinical failure patterns at 12 months

    Time frame: 12 months

    Clinical failure patterns included spontaneous pain, tenderness to percussion, pathological mobility, swelling, and sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars exhibiting each clinical failure pattern at the 12-month follow-up.

  8. Rate of radiographic failure patterns at 12 months

    Time frame: 12 months

    Radiographic failure patterns included periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars exhibiting each radiographic failure pattern at the 12-month follow-up.

  9. Rate of clinical treatment failure according to tooth type at 12 months

    Time frame: 12 months

    Clinical treatment failure was defined as the presence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars with clinical treatment failure according to tooth type (first or second primary molar).

  10. Rate of radiographic treatment failure according to tooth type at 12 months

    Time frame: 12 months

    Radiographic treatment failure was defined as the presence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, or periapical radiolucency. The outcome will be reported as the percentage of treated primary molars with radiographic treatment failure according to tooth type (first or second primary molar).

  11. Rate of clinical treatment failure according to dental arch at 12 months

    Time frame: 12 months

    Clinical treatment failure was defined as the presence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars with clinical treatment failure according to dental arch (maxillary or mandibular).

  12. Rate of radiographic treatment failure according to dental arch at 12 months

    Time frame: 12 months

    Radiographic treatment failure was defined as the presence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, or periapical radiolucency. The outcome will be reported as the percentage of treated primary molars with radiographic treatment failure according to dental arch (maxillary or mandibular).

  13. Rate of clinical treatment failure according to restoration type at 12 months

    Time frame: 12 months

    Clinical treatment failure was defined as the presence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars with clinical treatment failure according to restoration type (stainless steel crown or composite resin restoration).

  14. Rate of radiographic treatment failure according to restoration type at 12 months

    Time frame: 12 months

    Radiographic treatment failure was defined as the presence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, or periapical radiolucency. The outcome will be reported as the percentage of treated primary molars with radiographic treatment failure according to restoration type (stainless steel crown or composite resin restoration).

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

Comparative Evaluation of the Clinical and Radiographic Outcomes of Pulpotomy Materials in Primary Molars: A Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2026
Registry last updated
Aug 18, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.