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

Phase 2

Completed

• Conditions: Pulpitis - Irreversible
• Interventions: Drug: MTA pulp dressing material; Drug: Chitosan scaffold/ MTA pulp dressing material

• Registration Number: NCT04308863
• Lead Sponsor: Nourhan M.Aly

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.

Study Timeline

• Study Start: 2018-11-15
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-16
• Primary Completion: 2020-10-30
• Study Completion: 2020-12-20
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MTA pulp dressing material	MTA pulp dressing material	-
Chitosan scaffold/ MTA pulp dressing material	Chitosan scaffold/ MTA pulp dressing material	-

Primary Outcome Measures

Name	Time	Method
Root Canal Obliteration	12 months	Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
Internal Root Resorption	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
Pain Assessment	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.
Mineralization Activity	12 months	Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization

Secondary Outcome Measures

Name	Time	Method
Peri-radicular/furcal pathosis	12 months	Cone beam computed tomography (CBCT) analysis will be performed to detect presence/absence of any peri-radicular/furcal pathosis
Changes in the dental pulp in treated teeth	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)
Internal and external root resorption	12 months	Cone beam computed tomography (CBCT) analysis will be performed to detect presence/absence of internal or external root resorption

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt