Clinical trial NCT04308863: Evaluation of Chitosan Scaffold and Mineral Trioxide Aggregate Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
Official title: Evaluation of Chitosan Scaffold and Mineral Trioxide Aggregate Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulpitis - Irreversible
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Assessment
timeFrame: one week
measure: Mineralization Activity
timeFrame: baseline
measure: Mineralization Activity
timeFrame: 1 month
measure: Mineralization Activity
timeFrame: 3 months
measure: Mineralization Activity
timeFrame: 6 months
measure: Mineralization Activity
timeFrame: 9 months
measure: Mineralization Activity
timeFrame: 12 months
measure: Root Canal Obliteration
timeFrame: baseline
measure: Root Canal Obliteration
timeFrame: 1 month
measure: Root Canal Obliteration
timeFrame: 3 months
measure: Root Canal Obliteration
timeFrame: 6 months
measure: Root Canal Obliteration
timeFrame: 9 months
measure: Root Canal Obliteration
timeFrame: 12 months
measure: Internal Root Resorption
timeFrame: baseline
measure: Internal Root Resorption
timeFrame: 1 month
measure: Internal Root Resorption
timeFrame: 3 months
measure: Internal Root Resorption
timeFrame: 6 months
measure: Internal Root Resorption
timeFrame: 9 months
measure: Internal Root Resorption
timeFrame: 12 months
Secondary outcomes:
measure: Changes in the dental pulp in treated teeth
timeFrame: 6 months
measure: Peri-radicular/furcal pathosis
timeFrame: 12 months
measure: Internal and external root resorption
timeFrame: 12 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Maha T Aboul Kheir, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Rania M ElBackly, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Raef Sherif, PhD
role: STUDY_CHAIR
affiliation: European Egyptian Pharmaceutical Industries, Pharco Corporation, Alexandria, Egypt
name: Yasser Elkamary
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Nayera Mokhless, PhD
role: STUDY_CHAIR
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citation: Parirokh M, Torabinejad M. Mineral trioxide aggregate: a comprehensive literature review--Part III: Clinical applications, drawbacks, and mechanism of action. J Endod. 2010 Mar;36(3):400-13. doi: 10.1016/j.joen.2009.09.009.
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