NCT04262076

Brief Summary

Remineralization of carious affected dentin

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

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

June 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
Last Updated

February 11, 2020

Status Verified

January 1, 2020

Enrollment Period

1.5 years

First QC Date

January 26, 2020

Last Update Submit

February 9, 2020

Conditions

Deep Caries

Outcome Measures

Primary Outcomes (1)

  • Remineralization & increase dentin density that is measured by using Vista Scan Radiography.

    Vista scan Radiography used to measure pixel grey value after 6 months.

    6 months

Study Arms (2)

Combination of pulpine with Polyamidoamine Dendrimer

EXPERIMENTAL

Removal of Caries infected dentin from the walls and floor of the cavity and then apply polyamidoamine Denrimer for 30 secs ,then washed out of the cavity followed by placement of Pulpine over affected Dentin.

Other: Pulpine with Polyamidoamine Dendrimer

Pulpine

ACTIVE COMPARATOR

Removal of Caries infected dentin from the walls and the floor of the cavity followed by application of Pulpine over affected Dentin.

Other: Pulpine with Polyamidoamine Dendrimer

Interventions

Pulpine with Polyamidoamine DendrimerOTHER

Removal of infected dentin in class I Cavities followed by application of Polyamidoamine Denrimer on caries affected Dentin that is washed out of the cavity after 30 secs then finally place Pulpine .

Combination of pulpine with Polyamidoamine DendrimerPulpine

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Presence of at least one class one carious posterior teeth in both left and right side.
  • Absence of spontaneous pain, Mobility and tenderness on percussion.

You may not qualify if:

  • Patients with poor oral Hygiene.
  • Evidence of Rampant Caries.
  • Teeth with periodontal involvement.
  • Poor general health condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University, Faculty of Dentistry for Girls

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: split mouth design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2020

First Posted

February 10, 2020

Study Start

June 1, 2018

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

February 11, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

EG(1)