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

Sponsor

Minia University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05496257

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Direct Pulp Capping	Other: direct pulp capping in primary molars	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 2, 2021

Anticipated Primary Completion Date :

Nov 2, 2023

Anticipated Study Completion Date :

Dec 2, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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: Pain. Tenderness to palpation or percussion Gingival swelling or sinus tract. Purulent exudate expressed from the gingival margin. Abnormal tooth mobility.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

1. 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.

Exclusion Criteria:

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minia university	Minya		Egypt

Sponsors and Collaborators

Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Merrette Basem Khalaf Sedhom, Resident in Pediatric and Community Dentistry Department, Faculty of Dentistry, Assuit University, Assiut University

ClinicalTrials.gov Identifier:

NCT05496257

Other Study ID Numbers:

524_1/11/2021

First Posted:

Aug 11, 2022

Last Update Posted:

Aug 11, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 11, 2022