Direct Pulp Capping in Primary Molars

NCT05530954 | Completed Phase 3 DMC

• 1 other identifier: DPC in primary molars
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Direct Pulp Capping

Keywords

primary dentition; MTA; Dycal; bioactive material; deciduous dentition; Direct pulp capping

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Mineral trioxide aggregate (MTA)

ACTIVE COMPARATOR

* 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)

Hard setting Calcium Hydroxide (Dycal)

ACTIVE COMPARATOR

* 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)

Interventions

Mineral trioxide aggregate (MTA) OTHER

Materials for Vital Pulp Capping

Also known as: BIO MTA, CERKAMED, Poland

Mineral trioxide aggregate (MTA)

Hard setting Calcium Hydroxide (Dycal) OTHER

Materials for Vital Pulp Capping

Also known as: Dycal, Promedica Urbical, Germany

Hard setting Calcium Hydroxide (Dycal)

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

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

Al Mansurah, Egypt

Location

Related Publications (3)

• 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.

  PMID: 17256303 RESULT

• 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.

  PMID: 11585142 RESULT

• 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.

  PMID: 16536148 RESULT

Related Links

• © European Academy of Paediatric Dentistry 2018

MeSH Terms

Interventions

mineral trioxide aggregate; MTA Bio; Dycal

Study Officials

• S M Awad, PhD/Prof

  Head of Pediatric Dentistry and Dental Public Health, Mansoura University

  STUDY CHAIR

• A Y El Hosainy, PhD

  Lecturer of Pediatric Dentistry, Faculty of Dentistry, Mansoura University

  STUDY DIRECTOR

• N T El Saied, MSc

  PhD researcher at Faculty of Dentistry, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: capping material used
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD researcher of Pediatric Dentistry and Dental Public Health, Mansoura University

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

Study Record Dates

• First Submitted: September 3, 2022
• First Posted: September 7, 2022
• Study Start: January 1, 2022
• Primary Completion: May 27, 2023
• Study Completion: June 6, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)