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Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices

Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices: A Triple Blinded Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05876520
Acronym
I-PRF
Enrollment
28
Registered
2023-05-25
Start date
2023-01-25
Completion date
2024-04-30
Last updated
2023-05-25

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

Conditions

Vital Pulp Treatment in Mature Permanent Teeth With Irreversible Pulpitis

Brief summary

Clinical, Radiographic and pain assessment of Vital pulp treatment in patients suffering from irreversible pulpitis in mature permanent molars. Total pulpotomy is investigated using I-prf only vs I-prf mixed with Nano-bioactive glass.

Interventions

PROCEDURETotal pulpotomy with I-prf mixed with Nano-bioactive glass

Total pulpotomy is done in mature permanent molars followed by I-prf mixed with Nano-Bioactive glass application. Topped with BC putty for coronal seal, RMGI and restored with composite as final restoration

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Total Pulpotomy in mature permanent teeth treated with Nano-bioactive glass mixed with I-PRF

Eligibility

Sex/Gender
ALL
Age
14 Years to 32 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved. * Tooth should give positive response to cold test * Haemostasias should be achieved after total pulpotomy * The tooth is restorable and free from advanced periodontal disease, cracks and splits. * 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 apices * 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 any systemic disease that may affect normal healing. * Patients with periapical lesions or infections. * Pregnant females. * Patients who could/would not participate in a 6 months follow-up. * Patients with fistula or swelling * Patients with necrotic pulp. * Patients with old age.

Design outcomes

Primary

MeasureTime frameDescription
Clinical , Radiographic and Success rate6 month follow upPresence or absence of clinical signs and symptoms + Radiographic periapical assessment + success rate based on Radiographic findings

Secondary

MeasureTime frameDescription
Pain intensityWithin the first 24 hrs upto the 7th dayVAS used to record daily pain intensity

Countries

Egypt

Contacts

Primary ContactNoor K. Sayed
noor.kamal@dentistry.cu.edu.eg00201121818177
Backup ContactKamal K. Ahmed
noor.m.kamal35@gmail.com0020 101 4147393

Outcome results

None listed

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