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

Direct Pulp Capping Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05496257
• Other study ID #: 524_1/11/2021
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: December 2, 2023

Study information

• Verified date: August 2022
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2, 2023
• Est. primary completion date: November 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Direct Pulp Capping

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Egypt	Minia university	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Pain.; Tenderness to palpation or percussion; Gingival swelling or sinus tract.; Purulent exudate expressed from the gingival margin.; Abnormal tooth mobility.	2 year follow up