NCT04308863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

March 9, 2020

Last Update Submit

May 18, 2022

Conditions

Pulpitis - Irreversible

Outcome Measures

Primary Outcomes (19)

  • Pain Assessment

    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.

    one week

  • Mineralization Activity

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

    baseline

  • Mineralization Activity

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

    1 month

  • Mineralization Activity

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

    3 months

  • Mineralization Activity

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

    6 months

  • Mineralization Activity

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

    9 months

  • Mineralization Activity

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

    12 months

  • Root Canal Obliteration

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

    baseline

  • Root Canal Obliteration

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

    1 month

  • Root Canal Obliteration

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

    3 months

  • Root Canal Obliteration

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

    6 months

  • Root Canal Obliteration

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

    9 months

  • Root Canal Obliteration

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

    12 months

  • Internal Root Resorption

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

    baseline

  • Internal Root Resorption

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

    1 month

  • Internal Root Resorption

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

    3 months

  • Internal Root Resorption

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

    6 months

  • Internal Root Resorption

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

    9 months

  • Internal Root Resorption

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

    12 months

Secondary Outcomes (3)

  • Changes in the dental pulp in treated teeth

    6 months

  • Peri-radicular/furcal pathosis

    12 months

  • Internal and external root resorption

    12 months

Study Arms (2)

Chitosan scaffold/ MTA pulp dressing material

EXPERIMENTAL
Drug: Chitosan scaffold/ MTA pulp dressing material

MTA pulp dressing material

ACTIVE COMPARATOR
Drug: MTA pulp dressing material

Interventions

Chitosan scaffold/ MTA pulp dressing materialDRUG

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.

Chitosan scaffold/ MTA pulp dressing material
MTA pulp dressing materialDRUG

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.

MTA pulp dressing material

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • +3 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (5)

  • Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.

    PMID: 16504852BACKGROUND

  • 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.

    PMID: 20171353BACKGROUND

  • Kumar V, Juneja R, Duhan J, Sangwan P, Tewari S. Comparative evaluation of platelet-rich fibrin, mineral trioxide aggregate, and calcium hydroxide as pulpotomy agents in permanent molars with irreversible pulpitis: A randomized controlled trial. Contemp Clin Dent. 2016 Oct-Dec;7(4):512-518. doi: 10.4103/0976-237X.194107.

    PMID: 27994420BACKGROUND

  • Li F, Liu X, Zhao S, Wu H, Xu HH. Porous chitosan bilayer membrane containing TGF-beta1 loaded microspheres for pulp capping and reparative dentin formation in a dog model. Dent Mater. 2014 Feb;30(2):172-81. doi: 10.1016/j.dental.2013.11.005. Epub 2013 Dec 12.

    PMID: 24332410BACKGROUND

  • Ho MH, Kuo PY, Hsieh HJ, Hsien TY, Hou LT, Lai JY, Wang DM. Preparation of porous scaffolds by using freeze-extraction and freeze-gelation methods. Biomaterials. 2004 Jan;25(1):129-38. doi: 10.1016/s0142-9612(03)00483-6.

    PMID: 14580916BACKGROUND

Study Officials

  • Maha T Aboul Kheir, M.Sc

    Faculty of Dentistry, Alexandria University, Egypt

    PRINCIPAL INVESTIGATOR

  • Rania M ElBackly, PhD

    Faculty of Dentistry, Alexandria University, Egypt

    STUDY DIRECTOR

  • Raef Sherif, PhD

    Faculty of Dentistry, Alexandria University, Egypt

    STUDY CHAIR

  • Yasser Elkamary

    European Egyptian Pharmaceutical Industries, Pharco Corporation, Alexandria, Egypt

    STUDY CHAIR

  • Nayera Mokhless, PhD

    Faculty of Dentistry, Alexandria University, Egypt

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Instructor of Dental Public Health and Statistician

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 16, 2020

Study Start

November 15, 2018

Primary Completion

October 30, 2020

Study Completion

December 20, 2020

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations

EG(1)