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

Minia University100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Direct Pulp Capping

Interventions

direct pulp capping in primary molarsOTHER

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Minia university

Minya, Egypt

Outcomes

Primary Outcomes

Clinical findings

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.

Time frame: 2 year follow up

Data from ClinicalTrials.gov

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