ClinicalTrials.Veeva

Menu

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

M

Minia University

Status

Active, not recruiting

Conditions

Direct Pulp Capping

Treatments

Other: direct pulp capping in primary molars

Study type

Interventional

Funder types

Other

Identifiers

NCT05496257
524_1/11/2021

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 patients

Sex

All

Ages

4 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

    1. Clinical:

    2. Children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.

    3. Children rated as no. 3 or 4 in Frankl behaviour rating scale (FBRS).

    4. Presence of a small carious or traumatic pulp exposure (1 mm or less). 2. Radiographic:

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

Exclusion criteria

    1. Clinical:

    2. History of spontaneous unprovoked toothache.

    3. Extensive crown destruction that preclude coronal restoration.

    4. Gingival swelling, sinus tract or other soft tissue pathology.

    5. Abnormal tooth mobility.

    6. A frank pulp exposure (i.e., greater than 1.0mm), requiring pulpotomy.

    7. No evidence of visible pulp exposure.

      1. Radiographic:
    <!-- -->
    1. Furcation/periapical radiolucency.
    2. Pathological internal/external root resorption.
    3. Absence of underlying permanent successor

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Group I (control): Calcium hydroxide cement
Active Comparator group
Description:
Pulp capping material
Treatment:
Other: direct pulp capping in primary molars
Group 2: Premixed bioceramic putty
Active Comparator group
Description:
Pulp capping material
Treatment:
Other: direct pulp capping in primary molars

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems