Regenerative Potentials of Mature Mandibular Molars With Symptomatic Irreversible Pulpitis Enhanced With Different Scaffolds

NCT ID: NCT07196683

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2027-11-01

Brief Summary

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The current study aims to assess the influence of different scaffolds on postoperative pain and success rate of pulpotomy in mandibular mature molars with symptomatic irreversible pulpitis

Detailed Description

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The study aims to assess different scaffolds used in regenerative pulpotomy of mature permanent mandibular first molars diagnosed with symptomatic irreversible pulpitis and their influence on postoperative pain and clinical and radiographic success rate of pulpotomy. It also aims to correlate the level of inflammatory mediators in pulpal blood to the success rate of pulpotomy.

Conditions

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Symptomatic Irreversible Pulpitis (SIP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ascorbic acid augmented PRF scaffold

Group Type EXPERIMENTAL

Regenerative pulpotomy

Intervention Type PROCEDURE

Regenerative pulpotomy combines the use of hydraulic calcium silicate based cements; MTA, together with biodegradable scaffolds such as PRF.

Tannic acid cross linked PRF scaffold

Group Type EXPERIMENTAL

Regenerative pulpotomy

Intervention Type PROCEDURE

Regenerative pulpotomy combines the use of hydraulic calcium silicate based cements; MTA, together with biodegradable scaffolds such as PRF.

PRF scaffold

Group Type ACTIVE_COMPARATOR

Regenerative pulpotomy

Intervention Type PROCEDURE

Regenerative pulpotomy combines the use of hydraulic calcium silicate based cements; MTA, together with biodegradable scaffolds such as PRF.

Interventions

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Regenerative pulpotomy

Regenerative pulpotomy combines the use of hydraulic calcium silicate based cements; MTA, together with biodegradable scaffolds such as PRF.

Intervention Type PROCEDURE

Other Intervention Names

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Vital pulp therapy PRF pulpotomy

Eligibility Criteria

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Inclusion Criteria

* ASA I patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
* Age between 15-40 years.
* Males \& Females.
* Patients' acceptance to participate in the trial.
* Patients who can understand pain scale and can sign the informed consent (Appendix I).
* Mature mandibular fist molars:

* Diagnosed clinically with symptomatic irreversible pulpitis and normal periapical tissue.
* Giving a positive response to pulp sensitivity testing.
* Having negative response to percussion.
* Having normal radiographic appearance of periapical tissues.
* Having bright red color of pulp tissue, with hemorrhage control within 10 mins, upon access cavity preparation.

Exclusion Criteria

* Pregnant and lactating females.
* Patients with physical or mental handicapping conditions.
* Patients unwilling to participate in a 12-months follow up.
* Mandibular first molars with:

* Immature roots.
* Negative response to pulp sensitivity testing.
* Positive response to percussion.
* Radiographic evidence of periapical lesions, external or internal root resorption, vertical root fracture, or calcification.
* Intraoral swelling or fistula.
* Lack of pulpal bleeding, or inability to achieve hemostasis of the bleeding pulp within 10 mins, upon access cavity preparation.
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Omnia Abdel Hakim

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Omnia A Hakim, Assistant lecturer

Role: CONTACT

+201023636291

Other Identifiers

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New ENDO 5-5-1

Identifier Type: -

Identifier Source: org_study_id

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