Regenerative Potentials of Mature Mandibular Molars With Symptomatic Irreversible Pulpitis Enhanced With Different Scaffolds
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Regenerative pulpotomy.
- Who it may be relevant to
- Registry conditions: Symptomatic Irreversible Pulpitis (SIP). Basic parameters: 15 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Regenerative Potentials of Mature Mandibular First Molars With Symptomatic Irreversible Pulpitis Enhanced With Different Scaffolds: A Randomized Controlled Trial
Overview
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
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.
Interventions
- Procedure Regenerative pulpotomy
Regenerative pulpotomy combines the use of hydraulic calcium silicate based cements; MTA, together with biodegradable scaffolds such as PRF.
Primary outcome measures
- Intensity of postoperative pain [Time frame: 6, 12, 24, and 72 hours postoperatively]
Secondary outcome measures (2)
- Overall success rate [Time frame: 1, 3, 6, 9 and 12 months postoperatively.]
- IL-8 and TNF-α levels in pulpal blood [Time frame: Upon access cavity preparation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry, Cairo University — Cairo
Identifiers
NCT: NCT07196683 · New ENDO 5-5-1