CariesNCT02933463
Clinical Effectiveness of Embrace Wetbond and Clinpro as Pits and Fissure Sealants in Young Permanent Molars
A study testing Embrace Wetbond and Clinpro sealant in people with Caries, run by Cairo University.
Trial summary
This study is designed to clinically evaluate the retention and development of caries when using self-priming (Embrace wetbond) and conventional flowable composite (Clinpro) as pit and fissure sealant in young first permanent molars. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- Embrace Wetbond and Clinpro sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Aug 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged 6-9 years
- children with high caries risk
- cooperative children
- fully erupted first permanent molars
Who cannot join
- children with hypoplastic teeth
- partially erupted
- uncooperative children
- children with carious molars.
Trial locations and contacts
No sites are listed yet.
Randa Youssef, lecturer contact
About this study
Official title: Clinical Effectiveness of Embrace Wetbond and Clinpro as Pits and Fissure Sealants in Young Permanent Molars, Randomized Clinical Trial
This study is designed to clinically evaluate the retention and development of caries when using self-priming (Embrace wetbond) and conventional flowable composite (Clinpro) as pit and fissure sealant in young first permanent molars.
Read the detailed description
The aim of this study is designed to clinically evaluate the retention and development of caries when using self-priming (Embrace Wetbond) and conventional flowable composite (Clinpro) as pit and fissure sealant in young first permanent molars.
PICO:
P: children aged 6-9 years old with high caries risk.
I: Embrace Wetbond.
C: Clinpro seal.
O:
Primary outcome: Retention of sealant; Device of measurement: questionnaire; unit: binary.
Secondary outcome: Retention and development of caries; Device of measurement: Modified simonsen's criteria; Unit: scoring system (0-4) tactile and visual examination.
- Conditions
- Caries
- Being tested
- Embrace Wetbond, Clinpro sealant
- Keywords
- children with high caries risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embrace WetbondOther
not require an additional bonding agent hydrophilic, fluoride releasing
Clinpro sealantOther
| Study group | Role | What they receive |
|---|---|---|
| embrace wetbond sealant | Experimental | moisture tolerant resin based, have same properties of other sealant Receives: Other: Embrace Wetbond |
| clinpro sealant | Active comparator | is a dental resin, with low viscosity , fluoride releasing with a unique patented color change. Receives: Other: Clinpro sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of sealant
device for measurement: will make a questionnaire for the patients , unit of measurement: binary ( yes/no)
Measured: 6 months
Secondary outcomes (1)
Retention and development of caries
device of measurement: simonsen's criteria, unit of measurement: scoring system from 0-4 by tactile and visual examination.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Abdullah agina, Cairo University
- Investigators
- Mahmoud Hamdy, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933463
- Sponsor's protocol ID
- Nagina
- Status last verified
- Oct 2016
- First submitted
- 11 Oct 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Aleksejuniene J, Brondani MA, Pattanaporn K, Brukiene V. Best practices for dental sealants in community service-learning. J Dent Educ. 2010 Sep;74(9):951-60.
PubMed 20837736Al-Jobair A. Scanning electron microscope analysis of sealant penetration and adaptation in contaminated fissures. J Indian Soc Pedod Prev Dent. 2013 Jul-Sep;31(3):169-74. doi: 10.4103/0970-4388.117970.
PubMed 24021327Bhat PK, Konde S, Raj SN, Kumar NC. Moisture-tolerant resin-based sealant: A boon. Contemp Clin Dent. 2013 Jul;4(3):343-8. doi: 10.4103/0976-237X.118394.
PubMed 24124301Bhatia MR, Patel AR, Shirol DD. Evaluation of two resin based fissure sealants: a comparative clinical study. J Indian Soc Pedod Prev Dent. 2012 Jul-Sep;30(3):227-30. doi: 10.4103/0970-4388.105015.
PubMed 23263426Deery C, Fyffe HE, Nugent ZJ, Nuttall NM, Pitts NB. General dental practitioners diagnostic and treatment decisions related to fissure sealed surfaces. J Dent. 2000 Jul;28(5):313-8. doi: 10.1016/s0300-5712(00)00004-x.
PubMed 10785296Kane B, Karren J, Garcia-Godoy C, Garcia-Godoy F. Sealant adaptation and penetration into occlusal fissures. Am J Dent. 2009 Apr;22(2):89-91.
PubMed 19626971Morales-Chavez MC, Nualart-Grollmus ZC. Retention of a resin-based sealant and a glass ionomer used as a fissure sealant in children with special needs. J Clin Exp Dent. 2014 Dec 1;6(5):e551-5. doi: 10.4317/jced.51688. eCollection 2014 Dec.
PubMed 25674325Rohr M, Makinson OF, Burrow MF. Pits and fissures: morphology. ASDC J Dent Child. 1991 Mar-Apr;58(2):97-103.
PubMed 2050885Reddy VR, Chowdhary N, Mukunda KS, Kiran NK, Kavyarani BS, Pradeep MC. Retention of resin-based filled and unfilled pit and fissure sealants: A comparative clinical study. Contemp Clin Dent. 2015 Mar;6(Suppl 1):S18-23. doi: 10.4103/0976-237X.152932.
PubMed 25821368Schlueter N, Klimek J, Ganss C. Efficacy of a moisture-tolerant material for fissure sealing: a prospective randomised clinical trial. Clin Oral Investig. 2013 Apr;17(3):711-6. doi: 10.1007/s00784-012-0740-2. Epub 2012 May 3.
PubMed 22552593Khatri SG, Samuel SR, Acharya S, Patil S, Madan K. Retention of Moisture-tolerant and Conventional Resin-based Sealant in Six- to Nine-year-old Children. Pediatr Dent. 2015 Jul-Aug;37(4):366-70.
PubMed 26314605Going RE, Loesche WJ, Grainger DA, Syed SA. The viability of microorganisms in carious lesions five years after covering with a fissure sealant. J Am Dent Assoc. 1978 Sep;97(3):455-62. doi: 10.14219/jada.archive.1978.0327.
PubMed 279600Mitchell DA, Mitchell L. Oxford Handbook of Clinical Dentistry (4th edition). New York: Oxford University Press; 2005.
Ratnaditya A, Kumar MG , Jogenddrra SS,et al. Clinical evaluation of retention in hydrophobic and hydrophilic pit and fissure sealants-A Two Year Follow-Up Study. Journal of young pharmacist.2015;7(3):171.
Strassler HE and O'Donnell JP. A unique moisture tolerant resin based pit and fissure sealant.2008.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Embrace Wetbond and Clinpro as Pits and Fissure Sealants in Young Permanent Molars, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02933463
- Acronym / sponsor ID
- Nagina
- Conditions
- Caries
- Keywords
- children with high caries risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Aug 2017 (estimated)
- First posted
- 14 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.
This study is designed to clinically evaluate the retention and development of caries when using self-priming (Embrace wetbond) and conventional flowable composite (Clinpro) as pit and fissure sealant in young first permanent molars.
Detailed description
The aim of this study is designed to clinically evaluate the retention and development of caries when using self-priming (Embrace Wetbond) and conventional flowable composite (Clinpro) as pit and fissure sealant in young first permanent molars.
PICO:
P: children aged 6-9 years old with high caries risk.
I: Embrace Wetbond.
C: Clinpro seal.
O:
Primary outcome: Retention of sealant; Device of measurement: questionnaire; unit: binary.
Secondary outcome: Retention and development of caries; Device of measurement: Modified simonsen's criteria; Unit: scoring system (0-4) tactile and visual examination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| embrace wetbond sealant | Experimental | Other: Embrace Wetbondmoisture tolerant resin based, have same properties of other sealant |
| clinpro sealant | Active comparator | Other: Clinpro sealantis a dental resin, with low viscosity , fluoride releasing with a unique patented color change. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children aged 6-9 years
- children with high caries risk
- cooperative children
- fully erupted first permanent molars
Key exclusion criteria (4 listed)
- children with hypoplastic teeth
- partially erupted
- uncooperative children
- children with carious molars.
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 |
|---|---|---|
| Embrace Wetbondnot require an additional bonding agent hydrophilic, fluoride releasing | Other | embrace wetbond sealant |
| Clinpro sealant | Other | clinpro sealant |
Primary outcome
Retention of sealant
Time frame: 6 months
device for measurement: will make a questionnaire for the patients , unit of measurement: binary ( yes/no)
1 secondary outcome
Retention and development of caries
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Background: PubMed 20837736Aleksejuniene J, Brondani MA, Pattanaporn K, Brukiene V. Best practices for dental sealants in community service-learning. J Dent Educ. 2010 Sep;74(9):951-60.
- Background: PubMed 24021327Al-Jobair A. Scanning electron microscope analysis of sealant penetration and adaptation in contaminated fissures. J Indian Soc Pedod Prev Dent. 2013 Jul-Sep;31(3):169-74. doi: 10.4103/0970-4388.117970.
- Background: PubMed 24124301Bhat PK, Konde S, Raj SN, Kumar NC. Moisture-tolerant resin-based sealant: A boon. Contemp Clin Dent. 2013 Jul;4(3):343-8. doi: 10.4103/0976-237X.118394.
- Background: PubMed 23263426Bhatia MR, Patel AR, Shirol DD. Evaluation of two resin based fissure sealants: a comparative clinical study. J Indian Soc Pedod Prev Dent. 2012 Jul-Sep;30(3):227-30. doi: 10.4103/0970-4388.105015.
- Background: PubMed 10785296Deery C, Fyffe HE, Nugent ZJ, Nuttall NM, Pitts NB. General dental practitioners diagnostic and treatment decisions related to fissure sealed surfaces. J Dent. 2000 Jul;28(5):313-8. doi: 10.1016/s0300-5712(00)00004-x.
- Background: PubMed 19626971Kane B, Karren J, Garcia-Godoy C, Garcia-Godoy F. Sealant adaptation and penetration into occlusal fissures. Am J Dent. 2009 Apr;22(2):89-91.
- Background: PubMed 25674325Morales-Chavez MC, Nualart-Grollmus ZC. Retention of a resin-based sealant and a glass ionomer used as a fissure sealant in children with special needs. J Clin Exp Dent. 2014 Dec 1;6(5):e551-5. doi: 10.4317/jced.51688. eCollection 2014 Dec.
- Background: PubMed 2050885Rohr M, Makinson OF, Burrow MF. Pits and fissures: morphology. ASDC J Dent Child. 1991 Mar-Apr;58(2):97-103.
- Background: PubMed 25821368Reddy VR, Chowdhary N, Mukunda KS, Kiran NK, Kavyarani BS, Pradeep MC. Retention of resin-based filled and unfilled pit and fissure sealants: A comparative clinical study. Contemp Clin Dent. 2015 Mar;6(Suppl 1):S18-23. doi: 10.4103/0976-237X.152932.
- Background: PubMed 22552593Schlueter N, Klimek J, Ganss C. Efficacy of a moisture-tolerant material for fissure sealing: a prospective randomised clinical trial. Clin Oral Investig. 2013 Apr;17(3):711-6. doi: 10.1007/s00784-012-0740-2. Epub 2012 May 3.
- Background: PubMed 26314605Khatri SG, Samuel SR, Acharya S, Patil S, Madan K. Retention of Moisture-tolerant and Conventional Resin-based Sealant in Six- to Nine-year-old Children. Pediatr Dent. 2015 Jul-Aug;37(4):366-70.
- Background: PubMed 279600Going RE, Loesche WJ, Grainger DA, Syed SA. The viability of microorganisms in carious lesions five years after covering with a fissure sealant. J Am Dent Assoc. 1978 Sep;97(3):455-62. doi: 10.14219/jada.archive.1978.0327.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Randa Youssef, lecturer contact
Mahmoud Hamdy, professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Embrace Wetbond and Clinpro sealant in people with 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Nov 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha Abdullah Agina, bachelor (01008318352, noha-abdullah@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention of sealant (time frame: 6 months). 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 NCT02933463, which also lists 17 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 1 Nov 2016.