Remineralization of Caries Affected Dentin

Effect of Pulpine and Combination of Pulpine With Polyamidoamine Dendrimer on Remineralization of Carious Affected Human Dentin

Remineralization of carious affected dentin

Study Overview

• Status: Completed
• Conditions: Deep Caries
• Intervention / Treatment: Other: Pulpine with Polyamidoamine Dendrimer

Detailed Description

Remineralization of Carious affected dentin by using Pulpine alone and combination of Pulpine with Polyamidoamine Dendrimer.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Al-Azhar University, Faculty of Dentistry for Girls

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 23 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.
• Radiographically, the preoperative inclusion criteria are, no internal or external resorption and no widening of the periodontal membrane space.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination of pulpine with Polyamidoamine Dendrimer; 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; 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 .
Active Comparator: Pulpine; 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; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: January 26, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: REC17-01123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

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