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

NCT02930135 | Completed

• 1 other identifier: 1-10-2014
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Deep Caries

Keywords

Indirect Pulp Capping, Young Permanent Molars

Outcome Measures

Primary Outcomes (1)

• 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

  Immediate post operative, 2, 9 month

Secondary Outcomes (3)

• Absence of pain on percussion

  Immediate post operative, 2, 9 month

• Absence of post treatment swelling

  Immediate post operative, 2, 9 month

• Absence of adverse radiographic findings

  Immediate post operative, 2, 9 month

Study Arms (2)

Antibacterial Bond

EXPERIMENTAL

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

Conventional Bond

ACTIVE COMPARATOR

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

Interventions

Indirect pulp capping PROCEDURE

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

Also known as: Partial caries removal

Antibacterial Bond; Conventional Bond

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Teeth with previous restorative treatment.
• Unrestorable teeth.
• Uncooperative patients.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (5)

• 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.

  PMID: 17443547 BACKGROUND

• 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.

  PMID: 18548292 BACKGROUND

• 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.

  PMID: 22983407 BACKGROUND

• 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.

  PMID: 23649283 BACKGROUND

• 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.

  PMID: 24360260 BACKGROUND

Study Officials

• Dalia M Moheb, PhD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer in Pediatric Dentistry and Dental Public Health Department

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 12, 2016
• Study Start: August 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: March 1, 2017
• Last Updated: November 20, 2017

Record last verified: 2017-11