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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibacterial Bond | Experimental | Indirect pulp capping using antibacterial bond and x-tra fil composite
|
|
| Conventional Bond | Active Comparator | Indirect pulp capping using conventional bond and x-tra fil composite
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediate post operative, 2, 9 month |
| Absence of post treatment swelling |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalia M Moheb, PhD | Cairo University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17443547 | Background | 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. | |
| 18548292 | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 23, 2017 | |
| Unrelease | Yes | |
| Release | Jul 21, 2018 | |
| Reset | Jan 14, 2019 | |
| Release | Mar 23, 2019 | |
| Reset | Jun 20, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 23, 2017 | Yes | |||
| Jul 21, 2018 |
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|
Visual inspection of the gingiva, buccal and lingual mucoperiosteum related to the tooth if there is any swelling |
| Immediate post operative, 2, 9 month |
| Absence of adverse radiographic findings | Interradicular or periapical radiolucencies, thickening of the periodontal membrane space, internal and external root resorption | Immediate post operative, 2, 9 month |
| 22983407 | 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. |
| 23649283 | 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. |
| 24360260 | 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. |
| Jan 14, 2019 |
| Mar 23, 2019 | Jun 20, 2019 |