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Not yet recruiting NCT06828978

Clinical and Radiographic Success Following Regenerative Pulpotomy Using Chitosan Hydrogel Versus Platelet Rich Fibrin in Mature Mandibular Molars

No phase Interventional Regenerative Pulpotomy for Symptomatic Pulpitis of Mandibular Permanent Molars With Mature Apices

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: Full Pulpotomy.
Who it may be relevant to
Registry conditions: Regenerative Pulpotomy for Symptomatic Pulpitis of Mandibular Permanent Molars With Mature Apices. Basic parameters: 18 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinical and Radiographic Success Following Regenerative Pulpotomy Using Chitosan Hydrogel Versus Platelet Rich Fibrin in Mature Mandibular Molars: A Randomized Clinical Trial

Overview

The aim of this study is to assess the clinical and radiographic success and postoperative pain in mature mandibular molars following vital pulp therapy using chitosan hydrogel versus platelet rich fibrin.

Interventions

  • Procedure Full Pulpotomy
    After control of bleeding in teeth allocated to the intervention group, the gel is to be placed into the pulp chamber to a level 3 mm below the cementoenamel junction (CEJ) over the root pulp stumps.

Primary outcome measures

  • Success Rate [Time frame: 6 months (Postoperative)]
Secondary outcome measures (2)
  • Postoperative pain [Time frame: 1st day up to 7th day]
  • Tooth sensibility [Time frame: 1,3,6 months (postoperative)]

Eligibility criteria

Inclusion criteria

  • Patients suffering from Symptomatic pulpitis in mature mandibular molars only will be involved.
  • Tooth should give positive response to cold test
  • Haemostasis should be achieved after full 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 cannot be controlled after full 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06828978 · ENDO9-1-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗