Pulpitis - IrreversiblePhase 2NCT04308863

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

A Phase 2 study testing Chitosan scaffold/ MTA pulp dressing material and MTA pulp dressing material in people with Pulpitis - Irreversible, run by Nourhan M.Aly at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 50 years
Conditions the study is for: Pulpitis - Irreversible
What is being tested?: Chitosan scaffold/ MTA pulp dressing material and MTA pulp dressing material
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteEgypt
Study dates: 15 Nov 2018to 20 Dec 2020
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Show all 18Show fewer

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry, Alexandria University
Alexandria, 21512

Other trials in Egypt

About this study

Read the 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.

Conditions: Pulpitis - Irreversible
Being tested: Chitosan scaffold/ MTA pulp dressing material, MTA pulp dressing material

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.

Study groups in NCT04308863
Study group	Role	What they receive
Chitosan scaffold/ MTA pulp dressing material	Experimental	Not described Receives: Drug: Chitosan scaffold/ MTA pulp dressing material
MTA pulp dressing material	Active comparator	Not described Receives: Drug: MTA pulp dressing material

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: baseline
Mineralization Activity
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months

Secondary outcomes (3)

Changes in the dental pulp in treated teeth
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)
Measured: 6 months
Peri-radicular/furcal pathosis
Cone beam computed tomography (CBCT) analysis will be performed to detect presence/absence of any peri-radicular/furcal pathosis
Measured: 12 months
Internal and external root resorption
Cone beam computed tomography (CBCT) analysis will be performed to detect presence/absence of internal or external root resorption
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 201820 Dec 2020

First posted16 Mar 2020
Study start15 Nov 2018
Primary completion30 Oct 2020
Study completion20 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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).
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04308863
Sponsor's protocol ID: Chitosan vs MTA
Status last verified: May 2022
First submitted: 9 Mar 2020
Last updated: 19 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 16504852
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.
PubMed 20171353
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.
PubMed 27994420
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.
PubMed 24332410
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.
PubMed 14580916

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulpitis - Irreversible trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Chitosan Scaffold and Mineral Trioxide Aggregate Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
ClinicalTrials.gov ID: NCT04308863
Acronym / sponsor ID: Chitosan vs MTA
Conditions: Pulpitis - Irreversible
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Nourhan M.AlyUniversity, hospital or other
Collaborators: Alexandria University
Study start: 15 Nov 2018 (actual)
Primary completion: 30 Oct 2020 (actual)
Study completion: 20 Dec 2020 (actual)
First posted: 16 Mar 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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).

Arm	Type	Receives
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

Who may qualify

Ages: 20 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (18 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Chitosan scaffold/ MTA pulp dressing materialChitosan 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.	Drug	Chitosan scaffold/ MTA pulp dressing material
MTA pulp dressing materialMTA 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.	Drug	MTA pulp dressing material

Primary outcome

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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

3 secondary outcomes

Changes in the dental pulp in treated teeth
Time frame: 6 months
Peri-radicular/furcal pathosis
Time frame: 12 months
Internal and external root resorption
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
Background: PubMed 16504852Choukroun 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.
Background: PubMed 20171353Parirokh 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.
Background: PubMed 27994420Kumar 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.
Background: PubMed 24332410Li 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.
Background: PubMed 14580916Ho 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.

Related trials for Pulpitis - Irreversible

Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
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Not yet recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maha T Aboul Kheir, M.Sc principal investigator

Faculty of Dentistry, Alexandria University, Egypt

Rania M ElBackly, PhD study director

Faculty of Dentistry, Alexandria University, Egypt

Raef Sherif, PhD study chair

Faculty of Dentistry, Alexandria University, Egypt

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chitosan scaffold/ MTA pulp dressing material and MTA pulp dressing material in people with Pulpitis - Irreversible, run by Nourhan M.Aly at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Assessment (time frame: one week). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04308863, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.