Calcium Hydroxide Versus Premixed Bioceramic Putty in Direct Pulp Capping of Primary Molars

NCT ID: NCT05496257

Last Updated: 2022-08-11

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-02

Study Completion Date

2023-12-02

Brief Summary

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The trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars.

Detailed Description

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The current equivalent parallel randomized controlled trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars over a 24-month follow-up period.

Conditions

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Direct Pulp Capping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group I (control): Calcium hydroxide cement

Pulp capping material

Group Type ACTIVE_COMPARATOR

direct pulp capping in primary molars

Intervention Type OTHER

caries will be removed, and if the pulps are exposed, the material will be place directly over the exposed pulp.

Group 2: Premixed bioceramic putty

Pulp capping material

Group Type ACTIVE_COMPARATOR

direct pulp capping in primary molars

Intervention Type OTHER

caries will be removed, and if the pulps are exposed, the material will be place directly over the exposed pulp.

Interventions

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direct pulp capping in primary molars

caries will be removed, and if the pulps are exposed, the material will be place directly over the exposed pulp.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 1\. Clinical:

1. Children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
2. Children rated as no. 3 or 4 in Frankl behaviour rating scale (FBRS).
3. Presence of a small carious or traumatic pulp exposure (1 mm or less). 2. Radiographic:

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1. Presence of at least two-thirds of root length.
2. Normal lamina dura and periodontal ligament space.

Exclusion Criteria

* 1\. Clinical:

1. History of spontaneous unprovoked toothache.
2. Extensive crown destruction that preclude coronal restoration.
3. Gingival swelling, sinus tract or other soft tissue pathology.
4. Abnormal tooth mobility.
5. A frank pulp exposure (i.e., greater than 1.0mm), requiring pulpotomy.
6. No evidence of visible pulp exposure.

2\. Radiographic:

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1. Furcation/periapical radiolucency.
2. Pathological internal/external root resorption.
3. Absence of underlying permanent successor
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Merrette Basem Khalaf Sedhom

Resident in Pediatric and Community Dentistry Department, Faculty of Dentistry, Assuit University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Minia university

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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524_1/11/2021

Identifier Type: -

Identifier Source: org_study_id

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