Skip to content

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

Clinical and Radiographic Assessment of I-PRF Versus Nano Mineral Trioxide Aggregate Combined with I-PRF Scaffold in Vital Pulp Therapy in Mandibular First Molars with Closed Apices: Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06640205
Enrollment
51
Registered
2024-10-15
Start date
2023-09-03
Completion date
2025-09-02
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpotomy

Brief summary

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

Detailed description

Clinical and Radiographic Assessment of I-PRF versus Nano Mineral trioxide aggregate Combined with I-PRF Scaffold in Vital Pulp Therapy in Mandibular First Molars with Closed Apices: Randomized Controlled Trial

Interventions

PROCEDUREpulpotomy

Removal of coronal pulp tissue and then placing pulpotomy agent

Sponsors

Future University in Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* 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 * Patients should be free from any systemic disease that may affect normal healing and predictable outcome. * Patients who will agree to the consent and will commit to follow-up period. * Patients with mature root. * Patients with no internal or external resorption and no periapical lesions. * Soft tissues around the tooth are normal with no swelling or sinus tract.

Exclusion criteria

* Patients with immature roots. * Haemostasias after 10 minutes can not be controlled after total pulpotomy * Patients with periapical lesions or infections. * Pregnant females. * Patients with fistula or swelling * Patients with necrotic pulp.

Design outcomes

Primary

MeasureTime frameDescription
Post operative pain assessments6 hours post operative , 12 hours post operative , 24h (one day) post operative , 72h (3 days ) post operative and 7 days (one week) post operativePain 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.

Secondary

MeasureTime frameDescription
Clinical and radiographic success1 month post operative ,3 months clinical and radiograph ,6 months clinical and radiograph ,9 months clinical and radiograph and 12 months clinical and radiograph.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.

Countries

Egypt

Contacts

Primary Contactabdelrahman Mo Omar, Master
Abdulrahmanomar232@gmail.com00201000424892
Backup ContactMai Sh abdelwahed, Master
Memo_141967@hotmail.com01068609957

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026