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

NCT05496257 | Unknown

• 1 other identifier: 524_1/11/2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Direct Pulp Capping

Outcome Measures

Primary Outcomes (1)

• 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.

  2 year follow up

Study Arms (2)

Group I (control): Calcium hydroxide cement

ACTIVE COMPARATOR

Pulp capping material

Other: direct pulp capping in primary molars

Group 2: Premixed bioceramic putty

ACTIVE COMPARATOR

Pulp capping material

Other: direct pulp capping in primary molars

Interventions

direct pulp capping in primary molars OTHER

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

Group 2: Premixed bioceramic putty; Group I (control): Calcium hydroxide cement

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. Clinical:
• Children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
• Children rated as no. 3 or 4 in Frankl behaviour rating scale (FBRS).
• Presence of a small carious or traumatic pulp exposure (1 mm or less). 2. Radiographic:
• <!-- -->
• Presence of at least two-thirds of root length.
• Normal lamina dura and periodontal ligament space.

You may not qualify if:

• \. Clinical:
• History of spontaneous unprovoked toothache.
• Extensive crown destruction that preclude coronal restoration.
• Gingival swelling, sinus tract or other soft tissue pathology.
• Abnormal tooth mobility.
• A frank pulp exposure (i.e., greater than 1.0mm), requiring pulpotomy.
• No evidence of visible pulp exposure.
• \. Radiographic:
• <!-- -->
• Furcation/periapical radiolucency.
• Pathological internal/external root resorption.
• Absence of underlying permanent successor

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia university

Minya, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Pediatric and Community Dentistry Department, Faculty of Dentistry, Assuit University

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 11, 2022
• Study Start: November 2, 2021
• Primary Completion: November 2, 2023
• Study Completion: December 2, 2023
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

EG (1)