Clinical trial NCT05530954: Direct Pulp Capping in Primary Molars
Official title: Clinical Evaluation of Direct Pulp Capping in Primary Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Direct Pulp Capping
Keywords: primary dentition
MTA
Dycal
bioactive material
deciduous dentition
Direct pulp capping
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 52
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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. 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
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: clinical success of direct pulp capping treatment after 3 months follow up
timeFrame: 3 months
measure: clinical success of direct pulp capping treatment after 6 months follow up
timeFrame: 6 months follow up
measure: clinical success of direct pulp capping treatment after 9 months follow up
timeFrame: 9 months follow up
measure: clinical success of direct pulp capping treatment after 12 months follow up
timeFrame: 12 months follow up
measure: radiographic success of direct pulp capping treatment after 3 months follow up
timeFrame: 3 months follow up
measure: radiographic success of direct pulp capping treatment after 6 months follow up
timeFrame: 6 months follow up
measure: radiographic success of direct pulp capping treatment after 9 months follow up
timeFrame: 9 months follow up
measure: radiographic success of direct pulp capping treatment after 12 months follow up
timeFrame: 12 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Outpatient clinic of the Department of Pediatric Dentistry, Faculty of Dentistry- Mansoura University
Study officials:
affiliation: Head of Pediatric Dentistry and Dental Public Health, Mansoura University
name: S M Awad, PhD/Prof
role: STUDY_CHAIR
affiliation: Lecturer of Pediatric Dentistry, Faculty of Dentistry, Mansoura University
name: A Y El Hosainy, PhD
role: STUDY_DIRECTOR
affiliation: PhD researcher at Faculty of Dentistry, Mansoura University
name: N T El Saied, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.