Assessment of I-PRF Versus Nano MTA Combined with I-PRF Scaffold in Vital Pulp Therapy in Mature Mandibular First Molars

ConditionPulpotomy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age15-30

SponsorFuture University in Egypt

About this trial

Assessment of I-PRF versus Nano Mineral trioxide aggregate Combined with I-PRF in pulpotomy in mature Mandibular First Molars

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved.

Patients of either gender aged from 15-30.

Tooth should give positive response to cold test.

The tooth is restorable

Disqualifiers

Patients with immature roots.

Haemostasias after 10 minutes can not be controlled after total pulpotomy

Patients with periapical lesions or infections.

Pregnant females.

Trial design

Design model

Parallel

Treatments tested in this trial

pulpotomy
Procedure/Surgery
Removal of coronal pulp tissue and then placing pulpotomy agent

Treatment groups

51 Participants

are divided into 3 treatment groups

Group A: MTA PulpotomyActive comparator 1 intervention

Group B: I-PRF pulpotomyExperimental treatment 1 intervention

Group C: I-PRF combined with Nano MTA pulpotomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Post operative pain assessments

Pain assessments were made postoperatively with numerical rate scale. The scale includes scores from 0 to 10 where 0 indicates no pain , scores 1 to 3 indicates mild pain , scores 4 to 6 indicates moderate and scores 7 to 10 indicates severe pain.

Time frame

6 hours post operative , 12 hours post operative , 24h (one day) post operative , 72h (3 days ) post operative and 7 days (one week) post operative

Secondary outcomes

Clinical and radiographic success

Clinically success : this includes that the tooth must be symptoms free ( No pain on percussion , no pain on biting and no pain with cold and hot ) . Also the tooth must not has any signs of failure as appearance of sinus tract or fistula during the follow up periods. Radiographic success : this includes that the tooth did not develop a periapical radiolucency as periapical periodontitis . Any deviation from the previous success criteria ( as clinical or radiographic ) considered as failure and the tooth will be shifted to root canal treatment.

Time frame

1 month post operative ,3 months clinical and radiograph ,6 months clinical and radiograph ,9 months clinical and radiograph and 12 months clinical and radiograph.

Sponsors and contacts

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Future University in Egypt

Lead sponsor

Source ClinicalTrials.gov

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