NCT05464797

Brief Summary

This study aimed to evaluate the molecular changes that occur within the pulp tissue during inflammation and its correlation with vital pulp therapy with its different treatment modalities (Direct pulp capping, Partial Pulpotomy and Complete Pulpotomy).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
Last Updated

July 19, 2022

Status Verified

October 1, 2020

Enrollment Period

1.5 years

First QC Date

July 11, 2022

Last Update Submit

July 18, 2022

Conditions

Vital Pulp Therapy

Keywords

Partial PulpotomyCytokinesDirect Pulp Capping

Outcome Measures

Primary Outcomes (2)

  • Periradicular condition of the teeth

    Presence of any radiographic abnormal periapical change

    6 months

  • Level of Interleukin 8 in pulpal blood

    Severity of inflammation

    6 months

Secondary Outcomes (1)

  • Level of Matrix metalloproteinase 9 in pulpal blood

    6 months

Study Arms (5)

Control group

PLACEBO COMPARATOR
Diagnostic Test: Cytokines level in pulpal blood.

Direct Pulp Capping group

EXPERIMENTAL
Procedure: Pulp therapyDiagnostic Test: Cytokines level in pulpal blood.

Partial Pulpotomy group

EXPERIMENTAL
Procedure: Pulp therapyDiagnostic Test: Cytokines level in pulpal blood.

Complete Pulpotomy group

EXPERIMENTAL
Procedure: Pulp therapyDiagnostic Test: Cytokines level in pulpal blood.

Root canal treatment group

EXPERIMENTAL
Procedure: Pulp therapyDiagnostic Test: Cytokines level in pulpal blood.

Interventions

Pulp therapyPROCEDURE

partial or complete removal of inflamed pulp tissue

Complete Pulpotomy groupDirect Pulp Capping groupPartial Pulpotomy groupRoot canal treatment group
Cytokines level in pulpal blood.DIAGNOSTIC_TEST

Measuring the concentration of IL-8 and MMP-9 in the dental pulp during inflammation.

Complete Pulpotomy groupControl groupDirect Pulp Capping groupPartial Pulpotomy groupRoot canal treatment group

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Positive response to cold testing.
  • The age range from 15-45 years.
  • Patients of both sex.
  • Has clinical symptoms of pulpitis with normal apical tissues and supported by radiographic evaluation with no periradicular changes.

You may not qualify if:

  • Patients over 45 years of age.
  • Patients with clinical symptoms of periradicular inflammation or periradicular radiographic changes.
  • Negative response to cold testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakahliya, 35511, 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
SPONSOR

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 19, 2022

Study Start

December 12, 2020

Primary Completion

June 1, 2022

Study Completion

June 30, 2022

Last Updated

July 19, 2022

Record last verified: 2020-10

Locations

EG(1)