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Evaluation of Pulpotomy Using Two Different Agents in Mature Anterior Teeth With Pulpitis

ConditionPulpitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-14
SponsorAin Shams University

About this trial

the study will evaluate the clinical and radiological success of mature permanent anterior teeth pulpotomy in children and adolescents with signs of pulpitis using two different Biomimetic materials (NeoPutty® and Biodentine™) as a pulp dressing material in comparison to root canal treatment at 3, 6, 9 and 12 months follow up.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children and adolescents of both sexes aged between 9 and 14 years old.

Vital mature permanent anterior teeth with deep caries lesions that approach the pulp with signs of pulpitis and respond positive to cold pulp testing.

Vital mature permanent anterior teeth with pulpal exposure that occurred during caries excavation.

Patients presented immediately after suffering recent trauma (at the same day) to mature anterior teeth that had resulted in a crown fracture with pulp exposure.

Disqualifiers

Teeth with signs of infection such as swelling, sinus tract or pathological mobility or excessive mobility.

Teeth with excessive bleeding from amputated radicular stumps

Teeth showing radiographic evidence of pathologic root resorption, periapical pathology and calcifications in the canals.

Lack of patient/parent compliance and cooperation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • premixed Bioceramic NeoPUTTY®

    Procedure/Surgery

    Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic then final composite restoration will be applied. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.

  • Biodentine™

    Procedure/Surgery

    Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic or Biodentine™ according to the corresponding group then final composite restoration will be applied. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.

  • Root canal treatment

    Procedure/Surgery

    Root canal treatment will be performed to the control group followed by composite restoration. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.

Treatment groups

48 Participants
are divided into 3 treatment groups
Group A: Group A: The premixed Bioceramic NeoPUTTY® groupExperimental treatment 1 intervention
Group B: Group B: The Biodentine™ groupExperimental treatment 1 intervention
Group C: Group C: the root canal treatment groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical success

Absence of pain related to the treated teeth, including patient reported pain or sensitivity to percussion/palpation. No evidence of swelling of supporting soft tissue or presence of sinus tract. Absence of excessive mobility affecting treated teeth.

Time frame
3, 6, 9 and 12 months follow up
2

Radiographic success

No Internal or external root resorption. No Periapical radiolucency.

Time frame
3, 6, 9 and 12 months follow up

Secondary outcomes

1

Evaluation of tooth discoloration.

Evaluation of tooth discoloration using the VITA Easyshade V digital spectrophotometer.

Time frame
3, 6, 9 and 12 months follow up

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: