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Evaluation of Post Operative Pain Following Indirect Pulp Capping Using Antibacterial Bonding System

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ClinicalTrials.gov Identifier: NCT02930135
Recruitment Status : Completed
First Posted : October 12, 2016
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Shaimaa Mohamed Sabry Mostafa El Hanafy, Cairo University

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.

Condition or disease Intervention/treatment Phase
Deep Caries Procedure: Indirect pulp capping Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Antibacterial Bond

Indirect pulp capping using antibacterial bond and x-tra fil composite

  1. Local anesthesia administration
  2. Isolation of tooth with rubber dam
  3. Opening of the cavity and the removal of undermined enamel
  4. Caries at the lateral walls of the cavity and at the dentin-enamel junction is completely removed
  5. Partial removal of carious dentin on the pulp wall.
  6. Washing the cavity and dryness
  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) used as final tooth restoration.
Procedure: Indirect pulp capping
Removal of superficial caries in young permanent molars that my expose tooth pulp if totally removed leaving deep carious layers to be sealed inside with two step bonding system and bulk fill composite as a final restoration
Other Name: Partial caries removal

Active Comparator: Conventional Bond

Indirect pulp capping using conventional bond and x-tra fil composite

  1. Local anesthesia administration
  2. Isolation of tooth with rubber dam
  3. Opening of the cavity and the removal of undermined enamel
  4. Caries at the lateral walls of the cavity and at the dentin-enamel junction is completely removed
  5. Partial removal of carious dentin on the pulp wall.
  6. Washing the cavity and dryness
  7. Apply conventional light-cure, self-etching bonding agent (Clearfil SE Bond, Kuraray America, Inc.)
  8. Light-cured bulk fill composite (x-tra fil, VOCO) used as final tooth restoration.
Procedure: Indirect pulp capping
Removal of superficial caries in young permanent molars that my expose tooth pulp if totally removed leaving deep carious layers to be sealed inside with two step bonding system and bulk fill composite as a final restoration
Other Name: Partial caries removal




Primary Outcome Measures :
  1. change/evidence of post treatment spontaneous and provoked pain by questioning the patients [ Time Frame: Immediate post operative, 2, 9 month ]
    The patients are questioned if they experienced post-operative pain within the first 48 hours and then followed up after 2, 6, 9 month to check if there is a change in the situation and evidence of a complain


Secondary Outcome Measures :
  1. Absence of pain on percussion [ Time Frame: Immediate post operative, 2, 9 month ]
    Tapping the tooth occlusal surface using dental mirror, parallel to long axis of the tooth. check patient response if there is pain on percussion.

  2. Absence of post treatment swelling [ Time Frame: Immediate post operative, 2, 9 month ]
    Visual inspection of the gingiva, buccal and lingual mucoperiosteum related to the tooth if there is any swelling

  3. Absence of adverse radiographic findings [ Time Frame: Immediate post operative, 2, 9 month ]
    Interradicular or periapical radiolucencies, thickening of the periodontal membrane space, internal and external root resorption



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients free from any systemic diseases.
  2. Young permanent molars with deep carious lesions according to clinical and radiographic examination and at risk of pulp exposure if complete caries is removed.
  3. Absence of clinical pathologic signs (fistula, swelling and abnormal tooth mobility)
  4. The absence of clinical symptoms of irreversible pulpitis such as spontaneous pain or pain persisting after the disappearance of the existing stimulus or sensitivity to pressure.
  5. Absence of adverse radiographic findings (interradicular or periapical radiolucencies, thickening of the periodontal membrane space, internal and external root resorption).
  6. Compliant patient/parent.

Exclusion Criteria:

  1. Teeth with previous restorative treatment.
  2. Unrestorable teeth.
  3. Uncooperative patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930135


Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Dalia M Moheb, PhD Cairo University

Publications:
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Responsible Party: Shaimaa Mohamed Sabry Mostafa El Hanafy, Assistant Lecturer in Pediatric Dentistry and Dental Public Health Department, Cairo University
ClinicalTrials.gov Identifier: NCT02930135     History of Changes
Other Study ID Numbers: 1-10-2014
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shaimaa Mohamed Sabry Mostafa El Hanafy, Cairo University:
Indirect Pulp Capping, Young Permanent Molars

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents