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

Not Applicable

• Conditions: Direct Pulp Capping
• Interventions: Other: direct pulp capping in primary molars

• Registration Number: NCT05496257
• Lead Sponsor: Minia University

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.

Study Timeline

• Study Start: 2021-11-02
• Status Verified: 2022-08
• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Study First Posted: 2022-08-11
• Last Update Posted: 2022-08-11
• Primary Completion: 2023-11-02
• Study Completion: 2023-12-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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:

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  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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Premixed bioceramic putty	direct pulp capping in primary molars	Pulp capping material
Group I (control): Calcium hydroxide cement	direct pulp capping in primary molars	Pulp capping material

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Minia university; 🇪🇬 Minya, Egypt