Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Protooth Vs. MTA

NCT ID: NCT04710160

Last Updated: 2021-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2022-11-30

Brief Summary

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The aim of the study is to evaluate the clinical and radiographic success in pulpotomy using novel fast-setting calcium silicate cement (Protooth) versus MTA in exposed primary molars.

Detailed Description

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Conditions

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Clinical Evaluation Including Pain and Swelling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Novel fast setting calcium silicate ( Protooth)

In the form of powder and liquid to be mixed together to form paste.

Group Type ACTIVE_COMPARATOR

Novel fast-setting calcium silicate cement (Protooth)

Intervention Type DRUG

In form of power and liquid to be mixed together to form a paste.

MTA

In form of powder to be mixed with saline to form paste.

Group Type EXPERIMENTAL

Novel fast-setting calcium silicate cement (Protooth)

Intervention Type DRUG

In form of power and liquid to be mixed together to form a paste.

Interventions

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Novel fast-setting calcium silicate cement (Protooth)

In form of power and liquid to be mixed together to form a paste.

Intervention Type DRUG

Other Intervention Names

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mineral trioxide aggregate (MTA )

Eligibility Criteria

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Inclusion Criteria

* Complete physical and mental health, with no confounding history of systemic disease and/or use of special local or systemic drugs
* No allergic reactions recorded in patient history
* Having primary molar teeth in one jaw, having deep caries and vital pulp.
* No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule
* Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test

* Radiographic criteria:
* No sign of radiolucency in periapical or furcation area
* No widening of PDL space or loss of lamina dura continuity
* No evidence of internal/external pathologic root resorption

Exclusion Criteria

* Lack of informed consent by the child patient's parent
* Lack of informed consent by the child patient's parent
* Unable to attend follow-up visits.
* Refusal of participation.
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Nashwa Ossama Ahmed Elshaer

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentsitry , Cairo University

Cairo, El Manial, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Adel Elbardissy, professor

Role: CONTACT

01271289999

Passant Nagy, Doctorat

Role: CONTACT

0128557107

Facility Contacts

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Adel Elbardissy, Professor

Role: primary

01271289999

Passant Nagy, Doctorat

Role: backup

01280557107

Other Identifiers

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Pedo193

Identifier Type: -

Identifier Source: org_study_id

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