Status:
COMPLETED
Evaluation of Chitosan Scaffold and Mineral Trioxide Aggregate Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
Lead Sponsor:
Nourhan M.Aly
Collaborating Sponsors:
Alexandria University
Conditions:
Pulpitis - Irreversible
Eligibility:
All Genders
20-50 years
Phase:
PHASE2
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 irrev...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04308863
Start Date
November 15 2018
End Date
December 20 2020
Last Update
May 19 2022
Active Locations (1)
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1
Faculty of Dentistry, Alexandria University
Alexandria, Egypt, 21512