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NCT Number: NCT06640205

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

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

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Key information

Conditions

Pulpotomy

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Future university in egypt

Cairo, 11835, Egypt

Location status: Recruiting

Location contact

Abdelrahman Mo omar, Master

CONTACT

[email protected]

01000424892 ext. 002

About this study

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"

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulpotomy

Procedure

Removal of coronal pulp tissue and then placing pulpotomy agent

Other names: full pulpotomy, vital pulp therapy

Primary outcomes

  1. Post operative pain assessments

    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

    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.

Secondary outcomes

  1. Clinical and radiographic success

    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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mai Sh abdelwahed, Master

CONTACT

[email protected]

01068609957 ext. 002

abdelrahman Mo Omar, Master

CONTACT

[email protected]

00201000424892 ext. 002

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

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"

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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