Deep CariesNCT02930135
Evaluation of Post Operative Pain Following Indirect Pulp Capping Using Antibacterial Bonding System
A study testing Indirect pulp capping in people with Deep Caries, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries
- What is being tested?
- Indirect pulp capping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Teeth with previous restorative treatment.
- Unrestorable teeth.
- Uncooperative patients.
About this study
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
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.
Read the 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:
- 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
- Conditions
- Deep Caries
- Being tested
- Indirect pulp capping
- Keywords
- Indirect Pulp Capping, Young Permanent Molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect pulp cappingProcedure or surgery
Also called Partial caries removal
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Indirect pulp capping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediate post operative, 2, 9 month
Secondary outcomes (3)
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.
Measured: Immediate post operative, 2, 9 month
Absence of post treatment swelling
Visual inspection of the gingiva, buccal and lingual mucoperiosteum related to the tooth if there is any swelling
Measured: 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
Measured: Immediate post operative, 2, 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startAug 2015
- Primary completionNov 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Deep CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohamed Sabry Mostafa El Hanafy, Cairo University
- Investigators
- Dalia M Moheb, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930135
- Sponsor's protocol ID
- 1-10-2014
- Status last verified
- Nov 2017
- First submitted
- 3 Oct 2016
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17443547Orhan 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.
PubMed 18548292Maltz 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.
PubMed 22983407Reichert 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.
PubMed 23649283Bergenholtz 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.
PubMed 24360260
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02930135
- Acronym / sponsor ID
- 1-10-2014
- Conditions
- Deep Caries
- Keywords
- Indirect Pulp Capping, Young Permanent Molars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibacterial Bond | Experimental | Procedure: Indirect pulp cappingIndirect 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. |
| Conventional Bond | Active comparator | Procedure: Indirect pulp cappingIndirect 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. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- Teeth with previous restorative treatment.
- Unrestorable teeth.
- Uncooperative patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirect pulp cappingAlso: Partial caries removalRemoval 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 | Procedure or surgery | Antibacterial Bond, Conventional Bond |
Primary outcome
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
3 secondary outcomes
Absence of pain on percussion
Time frame: Immediate post operative, 2, 9 month
Absence of post treatment swelling
Time frame: Immediate post operative, 2, 9 month
Absence of adverse radiographic findings
Time frame: Immediate post operative, 2, 9 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Background: PubMed 17443547Miyashita 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.
- Background: PubMed 18548292Orhan 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.
- Background: PubMed 22983407Maltz 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.
- Background: PubMed 23649283Reichert 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.
- Background: PubMed 24360260Bergenholtz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalia M Moheb, PhD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Indirect pulp capping in people with Deep Caries, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change/evidence of post treatment spontaneous and provoked pain by questioning the patients (time frame: Immediate post operative, 2, 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02930135, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.