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

Primary Purpose

Deep Caries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Indirect pulp capping
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Caries focused on measuring Indirect Pulp Capping, Young Permanent Molars

Eligibility Criteria

6 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Antibacterial Bond

    Conventional Bond

    Arm Description

    Indirect pulp capping using antibacterial bond and x-tra fil composite Local anesthesia administration Isolation of tooth with rubber dam Opening of the cavity and the removal of undermined enamel Caries at the lateral walls of the cavity and at the dentin-enamel junction is completely removed Partial removal of carious dentin on the pulp wall. Washing the cavity and dryness Apply antibacterial light-cure, self-etching bonding agent (Clearfil SE Protect, Kuraray America, Inc.) Light-cured bulk fill composite (x-tra fil, VOCO) used as final tooth restoration.

    Indirect pulp capping using conventional bond and x-tra fil composite Local anesthesia administration Isolation of tooth with rubber dam Opening of the cavity and the removal of undermined enamel Caries at the lateral walls of the cavity and at the dentin-enamel junction is completely removed Partial removal of carious dentin on the pulp wall. Washing the cavity and dryness Apply conventional light-cure, self-etching bonding agent (Clearfil SE Bond, Kuraray America, Inc.) Light-cured bulk fill composite (x-tra fil, VOCO) used as final tooth restoration.

    Outcomes

    Primary Outcome Measures

    change/evidence of post treatment spontaneous and provoked pain by questioning the patients
    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

    Absence of pain on percussion
    Tapping the tooth occlusal surface using dental mirror, parallel to long axis of the tooth. check patient response if there is pain on percussion.
    Absence of post treatment swelling
    Visual inspection of the gingiva, buccal and lingual mucoperiosteum related to the tooth if there is any swelling
    Absence of adverse radiographic findings
    Interradicular or periapical radiolucencies, thickening of the periodontal membrane space, internal and external root resorption

    Full Information

    First Posted
    October 3, 2016
    Last Updated
    November 16, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02930135
    Brief Title
    Evaluation of Post Operative Pain Following Indirect Pulp Capping Using Antibacterial Bonding System
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    November 2016 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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: Local anesthesia. Isolation of tooth with rubber dam. Opening of the cavity and the removal of undermined enamel using high speed hand-piece with copious air/water spray and round burs. Caries at the lateral walls of the cavity and at the dentin-enamel junction is completely removed with excavators or low speed round burs. Partial removal of carious dentin (only soft disorganized dentin is removed) on the pulp wall. Washing the cavity with distilled water and dryness with triple airway syringe and sterile cotton. Apply antibacterial light-cure, self-etching bonding agent (Clearfil SE Protect, Kuraray America, Inc.) Light-cured bulk fill composite (x-tra fil, VOCO) will be used as final tooth restoration. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deep Caries
    Keywords
    Indirect Pulp Capping, Young Permanent Molars

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Antibacterial Bond
    Arm Type
    Experimental
    Arm Description
    Indirect pulp capping using antibacterial bond and x-tra fil composite Local anesthesia administration Isolation of tooth with rubber dam Opening of the cavity and the removal of undermined enamel Caries at the lateral walls of the cavity and at the dentin-enamel junction is completely removed Partial removal of carious dentin on the pulp wall. Washing the cavity and dryness Apply antibacterial light-cure, self-etching bonding agent (Clearfil SE Protect, Kuraray America, Inc.) Light-cured bulk fill composite (x-tra fil, VOCO) used as final tooth restoration.
    Arm Title
    Conventional Bond
    Arm Type
    Active Comparator
    Arm Description
    Indirect pulp capping using conventional bond and x-tra fil composite Local anesthesia administration Isolation of tooth with rubber dam Opening of the cavity and the removal of undermined enamel Caries at the lateral walls of the cavity and at the dentin-enamel junction is completely removed Partial removal of carious dentin on the pulp wall. Washing the cavity and dryness Apply conventional light-cure, self-etching bonding agent (Clearfil SE Bond, Kuraray America, Inc.) Light-cured bulk fill composite (x-tra fil, VOCO) used as final tooth restoration.
    Intervention Type
    Procedure
    Intervention Name(s)
    Indirect pulp capping
    Other Intervention Name(s)
    Partial caries removal
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    change/evidence of post treatment spontaneous and provoked pain by questioning the patients
    Description
    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
    Time Frame
    Immediate post operative, 2, 9 month
    Secondary Outcome Measure Information:
    Title
    Absence of pain on percussion
    Description
    Tapping the tooth occlusal surface using dental mirror, parallel to long axis of the tooth. check patient response if there is pain on percussion.
    Time Frame
    Immediate post operative, 2, 9 month
    Title
    Absence of post treatment swelling
    Description
    Visual inspection of the gingiva, buccal and lingual mucoperiosteum related to the tooth if there is any swelling
    Time Frame
    Immediate post operative, 2, 9 month
    Title
    Absence of adverse radiographic findings
    Description
    Interradicular or periapical radiolucencies, thickening of the periodontal membrane space, internal and external root resorption
    Time Frame
    Immediate post operative, 2, 9 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients free from any systemic diseases. Young permanent molars with deep carious lesions according to clinical and radiographic examination and at risk of pulp exposure if complete caries is removed. Absence of clinical pathologic signs (fistula, swelling and abnormal tooth mobility) 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. Absence of adverse radiographic findings (interradicular or periapical radiolucencies, thickening of the periodontal membrane space, internal and external root resorption). Compliant patient/parent. Exclusion Criteria: Teeth with previous restorative treatment. Unrestorable teeth. Uncooperative patients.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dalia M Moheb, PhD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    17443547
    Citation
    Miyashita H, Worthington HV, Qualtrough A, Plasschaert A. Pulp management for caries in adults: maintaining pulp vitality. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004484. doi: 10.1002/14651858.CD004484.pub2.
    Results Reference
    background
    PubMed Identifier
    18548292
    Citation
    Orhan AI, Oz FT, Ozcelik B, Orhan K. A clinical and microbiological comparative study of deep carious lesion treatment in deciduous and young permanent molars. Clin Oral Investig. 2008 Dec;12(4):369-78. doi: 10.1007/s00784-008-0208-6. Epub 2008 Jun 12.
    Results Reference
    background
    PubMed Identifier
    22983407
    Citation
    Maltz M, Garcia R, Jardim JJ, de Paula LM, Yamaguti PM, Moura MS, Garcia F, Nascimento C, Oliveira A, Mestrinho HD. Randomized trial of partial vs. stepwise caries removal: 3-year follow-up. J Dent Res. 2012 Nov;91(11):1026-31. doi: 10.1177/0022034512460403. Epub 2012 Sep 14.
    Results Reference
    background
    PubMed Identifier
    23649283
    Citation
    Reichert C. Randomized trial of partial vs. stepwise caries removal: 3-year follow-up. J Orofac Orthop. 2013 May 8. doi: 10.1007/s00056-013-0147-y. Online ahead of print. No abstract available.
    Results Reference
    background
    PubMed Identifier
    24360260
    Citation
    Bergenholtz G, Axelsson S, Davidson T, Frisk F, Hakeberg M, Kvist T, Norlund A, Petersson A, Portenier I, Sandberg H, Tranaeus S, Mejare I. Treatment of pulps in teeth affected by deep caries - A systematic review of the literature. Singapore Dent J. 2013 Dec;34(1):1-12. doi: 10.1016/j.sdj.2013.11.001.
    Results Reference
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    Evaluation of Post Operative Pain Following Indirect Pulp Capping Using Antibacterial Bonding System

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