Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-27 @ 10:38 PM
Study NCT ID:
NCT02930135
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2016-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Post Operative Pain Following Indirect Pulp Capping Using Antibacterial Bonding System
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Evaluation of Post Operative Pain Following Indirect Pulp Treatment in Young Permanent Teeth Using Antibacterial Versus Conventional Two-Step Bonding System: A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to compare the clinical and radiographic success of indirect pulp capping of vital young permanent teeth with deep caries using two-step antibacterial bonding system versus conventional one.
Detailed Description:
The study was carried out on patients attending outpatient clinic in Pediatric and Dental Public Health department- Faculty of Oral and Dental Medicine Cairo University- Egypt.
\*\*Sample size: On searching, no previous studies were conducted using neither conventional bonding nor antibacterial bonding in indirect pulp treatment in young permanent teeth, so sample size will be measured by estimation rather than calculation.
So, all patients attended outpatient clinic in Pediatric and Dental Public Health department- Faculty of Oral and Dental Medicine Cairo University- Egypt, In the period from 1/8/2015 - 31/10/2015 were enrolled for this study if they compatible with eligibility criteria.
\*\*Clinical Procedures:
I. Diagnosis:
Full personal, medical and dental history,clinical and radiographic examination.
II. Allocation concealment:
Selected envelopes will be opened in the first visit to allocate the patients to their treatment groups .
III.Intervention:
A- Experimental Group: Indirect pulp capping with Antibacterial Two-Step Bonding System:
1. Local anesthesia.
2. Isolation of tooth with rubber dam.
3. Opening of the cavity and the removal of undermined enamel using high speed hand-piece with copious air/water spray and round burs.
4. Caries at the lateral walls of the cavity and at the dentin-enamel junction is completely removed with excavators or low speed round burs.
5. Partial removal of carious dentin (only soft disorganized dentin is removed) on the pulp wall.
6. Washing the cavity with distilled water and dryness with triple airway syringe and sterile cotton.
7. Apply antibacterial light-cure, self-etching bonding agent (Clearfil SE Protect, Kuraray America, Inc.)
8. Light-cured bulk fill composite (x-tra fil, VOCO) will be used as final tooth restoration.
9. Postoperative digital radiograph will be taken as a base line.
B- Comparative Group: Indirect pulp capping with Conventional Two-Step Bonding System Same as that of the experimental group EXCEPT steps number 5 as conventional light-cure, self-etching bonding agent (Clearfil SE Bond, Kuraray America, Inc.) will be applied into cavity according to manufacturer's instruction.
IV. Follow up and postoperative instructions:
\- Patients will be recalled 48 hours after the treatment then at 2, 9 months
\*\*Sample size: On searching, no previous studies were conducted using neither conventional bonding nor antibacterial bonding in indirect pulp treatment in young permanent teeth, so sample size will be measured by estimation rather than calculation.
So, all patients attended outpatient clinic in Pediatric and Dental Public Health department- Faculty of Oral and Dental Medicine Cairo University- Egypt, In the period from 1/8/2015 - 31/10/2015 were enrolled for this study if they compatible with eligibility criteria.
\*\*Clinical Procedures:
I. Diagnosis:
Full personal, medical and dental history,clinical and radiographic examination.
II. Allocation concealment:
Selected envelopes will be opened in the first visit to allocate the patients to their treatment groups .
III.Intervention:
A- Experimental Group: Indirect pulp capping with Antibacterial Two-Step Bonding System:
1. Local anesthesia.
2. Isolation of tooth with rubber dam.
3. Opening of the cavity and the removal of undermined enamel using high speed hand-piece with copious air/water spray and round burs.
4. Caries at the lateral walls of the cavity and at the dentin-enamel junction is completely removed with excavators or low speed round burs.
5. Partial removal of carious dentin (only soft disorganized dentin is removed) on the pulp wall.
6. Washing the cavity with distilled water and dryness with triple airway syringe and sterile cotton.
7. Apply antibacterial light-cure, self-etching bonding agent (Clearfil SE Protect, Kuraray America, Inc.)
8. Light-cured bulk fill composite (x-tra fil, VOCO) will be used as final tooth restoration.
9. Postoperative digital radiograph will be taken as a base line.
B- Comparative Group: Indirect pulp capping with Conventional Two-Step Bonding System Same as that of the experimental group EXCEPT steps number 5 as conventional light-cure, self-etching bonding agent (Clearfil SE Bond, Kuraray America, Inc.) will be applied into cavity according to manufacturer's instruction.
IV. Follow up and postoperative instructions:
\- Patients will be recalled 48 hours after the treatment then at 2, 9 months
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: