Direct Pulp Capping in Primary Molars

Clinical Evaluation of Direct Pulp Capping in Primary Molars

The purpose of this study is to Assess the effect of MTA and hard setting Calcium Hydroxide (Dycal) on the clinical and radiographic outcome of direct pulp capping in primary molars and evaluate overall success rate of direct pulp capping in primary molars.

Study Overview

• Status: Completed
• Conditions: Direct Pulp Capping
• Intervention / Treatment: Other: Mineral trioxide aggregate (MTA); Other: Hard setting Calcium Hydroxide (Dycal)

Detailed Description

After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in patient examination sheet.

Participants who met the inclusion criteria were randomly allocated to two groups (n = 26/group, N = 52 in total) according to the capping martials using the envelope randomization method.

2 study groups according to capping material that will be used (Dycal or MTA) and each group will be divided to 2 subgroups according to site of exposure axial or pulpal.

All patients were recalled and their treated molars were evaluated clinically and radiographically at 3months, 6months, 9months ,12months follow up periods.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Outpatient clinic of the Department of Pediatric Dentistry, Faculty of Dentistry- Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Cooperative child and compliant parent.
• Complete physical and mental health.
• Children who are known to be healthy and free from systemic diseases.
• Primary molars with deep carious lesions leading to pathological exposure but with no signs or symptoms of irreversible pulpitis or necrosis such as spontaneous pain, tenderness to percussion, abscess, fistula, periodontal tissue swelling, or abnormal tooth mobility.

Exclusion Criteria:

• A deep carious lesion in close proximity to the pulp with an intact lamina dura.
• Absence of widening of periodontal membrane space or radiolucency at the furcation and periapical region.
• Absence of pulpal calcifications, obliteration of the pulp and root canal, or internal/external root resorption.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mineral trioxide aggregate (MTA); where the pulp tissue is exposed during final caries removal, hemostasis will be achieved by cavity irrigation with sterile saline solution for up to 4 minutes till control of bleeding; Teeth with pulp exposure less than 1mm in diameter surrounded by sound dentin will be candidates for direct pulp capping; Following the removal of the saline, the exposed pulp will be irrigated with 17% EDTA solution (Prevest Direct, India) for 1 minute; According to site of exposure, the groups will be further subdivided into Group A (n=13) with exposure in pulpal floor and Group B (n=13) with exposure in axial wall of the cavity.; Exposed pulp will be covered with fast set MTA paste after cavity dryness with sterile cotton pellet then the tooth will be restored with Self-cured glass ionomer restorative material (SDI Riva self-cure, Australia) and tooth will be covered by stainless steel crown	Other: Mineral trioxide aggregate (MTA); Materials for Vital Pulp Capping; Other Names: BIO MTA; CERKAMED, Poland
Active Comparator: Hard setting Calcium Hydroxide (Dycal); where the pulp tissue is exposed during final caries removal, hemostasis will be achieved by cavity irrigation with sterile saline solution for up to 4 minutes till control of bleeding; Teeth with pulp exposure less than 1mm in diameter surrounded by sound dentin will be candidates for direct pulp capping; Following the removal of the saline, the exposed pulp will be irrigated with 17% EDTA solution (Prevest Direct, India) for 1 minute; According to site of exposure, the groups will be further subdivided into Group A (n=13) with exposure in pulpal floor and Group B (n=13) with exposure in axial wall of the cavity.; Exposed pulp will be covered with Dycal paste after cavity dryness with sterile cotton pellet then the tooth will be restored with Self-cured glass ionomer restorative material (SDI Riva self-cure, Australia) and tooth will be covered by stainless steel crown	Other: Hard setting Calcium Hydroxide (Dycal); Materials for Vital Pulp Capping; Other Names: Dycal; Promedica Urbical, Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical success of direct pulp capping treatment after 3 months follow up	Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.	3 months
clinical success of direct pulp capping treatment after 6 months follow up	Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.	6 months follow up
clinical success of direct pulp capping treatment after 9 months follow up	Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.	9 months follow up
clinical success of direct pulp capping treatment after 12 months follow up	Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.	12 months follow up
radiographic success of direct pulp capping treatment after 3 months follow up	the absence of the following radiographic findings indicate the success of capping material in pulp therapy: pathological internal or external root resorption.; PDL widening.; inter-radicular radiolucency formation postoperatively.; periapical radiolucency formation postoperatively.	3 months follow up
radiographic success of direct pulp capping treatment after 6 months follow up	the absence of the following radiographic findings indicate the success of capping material in pulp therapy: pathological internal or external root resorption.; PDL widening.; inter-radicular radiolucency formation postoperatively.; periapical radiolucency formation postoperatively.	6 months follow up
radiographic success of direct pulp capping treatment after 9 months follow up	the absence of the following radiographic findings indicate the success of capping material in pulp therapy: pathological internal or external root resorption.; PDL widening.; inter-radicular radiolucency formation postoperatively.; periapical radiolucency formation postoperatively.	9 months follow up
radiographic success of direct pulp capping treatment after 12 months follow up	the absence of the following radiographic findings indicate the success of capping material in pulp therapy: pathological internal or external root resorption.; PDL widening.; inter-radicular radiolucency formation postoperatively.; periapical radiolucency formation postoperatively.	12 months follow up

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: S M Awad, PhD/Prof, Head of Pediatric Dentistry and Dental Public Health, Mansoura University; Study Director: A Y El Hosainy, PhD, Lecturer of Pediatric Dentistry, Faculty of Dentistry, Mansoura University; Principal Investigator: N T El Saied, MSc, PhD researcher at Faculty of Dentistry, Mansoura University

Publications and helpful links

General Publications

• Caicedo R, Abbott PV, Alongi DJ, Alarcon MY. Clinical, radiographic and histological analysis of the effects of mineral trioxide aggregate used in direct pulp capping and pulpotomies of primary teeth. Aust Dent J. 2006 Dec;51(4):297-305. doi: 10.1111/j.1834-7819.2006.tb00447.x.
• Faraco IM Jr, Holland R. Response of the pulp of dogs to capping with mineral trioxide aggregate or a calcium hydroxide cement. Dent Traumatol. 2001 Aug;17(4):163-6. doi: 10.1034/j.1600-9657.2001.170405.x.
• de Lourdes Rodrigues Accorinte M, Reis A, Dourado Loguercio A, Cavalcanti de Araujo V, Muench A. Influence of rubber dam isolation on human pulp responses after capping with calcium hydroxide and an adhesive system. Quintessence Int. 2006 Mar;37(3):205-12.

Helpful Links

• © European Academy of Paediatric Dentistry 2018

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): May 27, 2023
• Study Completion (Actual): June 6, 2023

Study Registration Dates

• First Submitted: September 3, 2022
• First Submitted That Met QC Criteria: September 3, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: MTA; primary dentition; deciduous dentition; Dycal; bioactive material; Direct pulp capping
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: DPC in primary molars

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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