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

Calcium Hydroxide Versus Premixed Bioceramic Putty in Direct Pulp Capping of Primary Molars: An Equivalent Parallel Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05496257

Enrollment

100

Registered

2022-08-11

Start date

2021-11-02

Completion date

2023-12-02

Last updated

2022-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Direct Pulp Capping

Brief summary

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

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.

Interventions

OTHERdirect 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Years to 6 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical findings	2 year follow up	The children will be recalled for postoperative clinical & radiographic assessments at the following intervals; six, twelve, eighteen,and twenty-four months.the treatment will be considered successful if none of the following clinical or radiographic findings is present: Clinical criteria: 1. Pain. 2. Tenderness to palpation or percussion 3. Gingival swelling or sinus tract. 4. Purulent exudate expressed from the gingival margin. 5. Abnormal tooth mobility.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026