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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Direct Pulp Capping
• Intervention / Treatment: Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group I (control): Calcium hydroxide cement; Pulp capping material	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.
ACTIVE_COMPARATOR: Group 2: Premixed bioceramic putty; Pulp capping material	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2021
• Primary Completion (ANTICIPATED): November 2, 2023
• Study Completion (ANTICIPATED): December 2, 2023

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (ACTUAL): August 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 524_1/11/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No