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Completed

NCT Number: NCT04308863

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

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.

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Key information

Conditions

Pulpitis - Irreversible

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Normal periapical structures.
  • Small changes in bone structures.
  • Change in bone structure with mineral loss.
  • Periodontitis with well-defined radiolucent area.
  • 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.

Treatment and study plan

Chitosan scaffold/ MTA pulp dressing material

Drug

Chitosan 3-D porous scaffold will be prepared. The chitosan scaffolds will be examined with the Scanning electron microscopy (SEM) to analyze the surface of the chitosan scaffolds. The scaffolds will be sterilized by Ethylene oxide and stored until further use. A piece of 2-mm thick chitosan scaffold will be gently placed onto the pulp chamber floor and covering the canal orifices, and then a 2-3 mm thick layer of fast setting EndoCem Zr MTA will be applied onto the chitosan scaffold and will be gently condensed with moistened cotton pellet to attain adequate thickness which will be confirmed radiographically. MTA will be allowed to set for 4-5 mins.

MTA pulp dressing material

Drug

MTA will be gently placed over the fresh pulp wound using an MTA carrier to a thickness of 2-3 mm. It will be condensed lightly with moistened cotton pellet to attain adequate thickness and confirmed radiographically. MTA will be allowed to set for 4-5 mins.

Primary outcomes

  1. Pain Assessment

    Time frame: one week

    Postoperative pain will be recorded on Numerical Rating Pain Scale (NRS) that will be given to the patient to record his pain intensity in the range between 0-10, until the seventh day after treatment. Pain on the NRS will be further categorized as: No pain (0), Mild (1-3), Moderate (4-6), and Severe (7-10) pain.

  2. Mineralization Activity

    Time frame: baseline

    Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization

  3. Mineralization Activity

    Time frame: 1 month

    Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization

  4. Mineralization Activity

    Time frame: 3 months

    Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization

  5. Mineralization Activity

    Time frame: 6 months

    Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization

  6. Mineralization Activity

    Time frame: 9 months

    Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization

  7. Mineralization Activity

    Time frame: 12 months

    Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization

  8. Root Canal Obliteration

    Time frame: baseline

    Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration

  9. Root Canal Obliteration

    Time frame: 1 month

    Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration

  10. Root Canal Obliteration

    Time frame: 3 months

    Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration

  11. Root Canal Obliteration

    Time frame: 6 months

    Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration

  12. Root Canal Obliteration

    Time frame: 9 months

    Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration

  13. Root Canal Obliteration

    Time frame: 12 months

    Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration

  14. Internal Root Resorption

    Time frame: baseline

    Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption

  15. Internal Root Resorption

    Time frame: 1 month

    Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption

  16. Internal Root Resorption

    Time frame: 3 months

    Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption

  17. Internal Root Resorption

    Time frame: 6 months

    Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption

  18. Internal Root Resorption

    Time frame: 9 months

    Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption

  19. Internal Root Resorption

    Time frame: 12 months

    Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption

Secondary outcomes

  1. Changes in the dental pulp in treated teeth

    Time frame: 6 months

    This will be performed in comparison to a non-affected tooth with clinical vitality and without any additional past treatment. All observers will analyze the images using the following rating scale regarding to alterations of signal intensity of the dental pulp at nT1w, fsT1w, and fsT2w at distinct time intervals (1 = no signs of alterations of signal intensity of the dental pulp between affected and non-affected teeth, 2 = slightly alterations of signal intensity of the dental pulp between affected and nonaffected teeth, and 3 = obvious alterations of signal intensity of the dental pulp between affected and nonaffected teeth)

  2. Peri-radicular/furcal pathosis

    Time frame: 12 months

    Cone beam computed tomography (CBCT) analysis will be performed to detect presence/absence of any peri-radicular/furcal pathosis

  3. Internal and external root resorption

    Time frame: 12 months

    Cone beam computed tomography (CBCT) analysis will be performed to detect presence/absence of internal or external root resorption

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 16, 2020
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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