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Evaluation of Chitosan Scaffold and Mineral Trioxide Aggregate Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis

N

Nourhan M.Aly

Status and phase

Completed
Phase 2

Conditions

Pulpitis - Irreversible

Treatments

Drug: MTA pulp dressing material
Drug: Chitosan scaffold/ MTA pulp dressing material

Study type

Interventional

Funder types

Other

Identifiers

NCT04308863
Chitosan vs MTA

Details and patient eligibility

About

The aim of this study is to evaluate the clinical and radiographic outcomes of Chitosan scaffold and Mineral trioxide aggregate (MTA) when used as pulpotomy agents in mature permanent teeth with irreversible pulpitis.

Full description

Thirty permanent mandibular molars of patients with signs and symptoms of irreversible pulpitis will be selected. They will be randomly allocated into two groups, Group 1(Chitosan scaffold/ MTA pulp dressing materials), Group 2 (MTA pulp dressing material). A single visit full pulpotomy procedure will be carried out. Chitosan scaffold and / or MTA will be used as the pulp dressing materials. The teeth will be then restored with base of Glass ionomer cement followed by composite restoration.

Enrollment

30 patients

Sex

All

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants free from any systemic disease.

  • Deep caries in a permanent lower molar with mature roots.

  • Probing pocket depth and mobility within normal limits.

  • No signs of pulpal necrosis including sinus tract or swelling.

  • Vital bleeding pulp tissue should be present in all canals after complete pulpotomy.

  • The tooth is restorable.

  • Clinical diagnosis of symptomatic irreversible pulpitis based on subjective and objective examinations:

    • Subjective examination: Patients complaining of intermittent or spontaneous pain or pain exacerbated by dramatic temperature changes especially to cold stimuli and lasting for a few seconds to several hours.

    • Objective examination:

      • Clinical examination: Teeth that will experience immediate, excruciatingly painful sensation as soon as the cold stimulus is placed on and which may last for a while even after the removal of the stimulus.

      • Radiographic examination: Preoperative radiographs will be taken using a paralleling device.

      • The periapical index developed by Orstavik et al. (1986)(35) will be used to score cases with periapical rarefaction during diagnosis and follow-up periods. It consists of five categories:

        1. Normal periapical structures.
        2. Small changes in bone structures.
        3. Change in bone structure with mineral loss.
        4. Periodontitis with well-defined radiolucent area.
        5. Severe periodontitis with exacerbating features. Score 1 and 2 are considered healthy, score 3-5 are considered diseased
      • The teeth that will be included should have score 1 or 2.

Exclusion criteria

  • Negative response to cold testing.
  • No pulp exposure after caries excavation.
  • Bleeding could not be controlled in 10 minutes after 2.5% NaOCl
  • Absence of bleeding from any of the canals.
  • Teeth with radiographic signs of internal resorption.
  • Pulpal calcifications.
  • Participants with stainless-steel wires and brackets.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Chitosan scaffold/ MTA pulp dressing material
Experimental group
Treatment:
Drug: Chitosan scaffold/ MTA pulp dressing material
MTA pulp dressing material
Active Comparator group
Treatment:
Drug: MTA pulp dressing material

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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