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RecruitingNCT06640205Updated Oct 15, 2024

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

An interventional study of pulpotomy in Pulpotomy, sponsored by Future University in Egypt. Recruiting at 1 site in Egypt. Open to participants aged 15 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Sep 2023, registered Aug 2024).
  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
15 Years to 30 Years
Sex
All
01

Study summary

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

Read the 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"

02

Conditions studied

  • Pulpotomy
03

In context

Lead sponsor

Future University in Egypt is the lead sponsor of 97 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 30 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
51 participants (estimated)

Study arms

  • Active comparator
    MTA Pulpotomy

    using MTA as pulpotomy capping agent in mature permanent teeth

    Procedure: pulpotomy

  • Experimental
    I-PRF pulpotomy

    using I-PRF as pulpotomy capping agent in mature permanent teeth

    Procedure: pulpotomy

  • Experimental
    I-PRF combined with Nano MTA pulpotomy

    using nano MTA mixed with I-prf as pulpotomy capping agent in mature permanent teeth

    Procedure: pulpotomy

Interventions

  • Procedurepulpotomy

    Removal of coronal pulp tissue and then placing pulpotomy agent

    Also known as: full pulpotomy, vital pulp therapy

06

What researchers measure

Primary outcomes

  1. 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

  1. 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.

07

Study locations

1 of 1 sites recruiting
  • Future university in egypt
    Cairo, 11835, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06640205
Lead sponsor
Future University in Egypt
Responsible party
Abdelrahman Mohamed Elsayed Metwally Omar (Principle investigator, Future University in Egypt) — Principal investigator
First posted
Oct 15, 2024
Start date
Sep 3, 2023
Primary completion
Sep 2, 2024
Completion
Sep 2, 2025 (estimated)
Last update
Oct 15, 2024

Study contacts

abdelrahman Mo Omar, Master
Contact
Abdulrahmanomar232@gmail.com
00201000424892 ext. 002
Mai Sh abdelwahed, Master
Contact
Memo_141967@hotmail.com
01068609957 ext. 002
Abdelrahman Mo Omar, Master
study chair · Future University in Egypt

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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