Fissure Sealant LossPhase 2/3FSRTNCT00873990
Fissure Sealant Retention Trial
A Phase 2/3 study testing Total etch bonding agent (5th generation) and Self etch (7th generation ) bonding agent in people with Fissure Sealant Loss, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The aim of the investigators study is to compare how two different bonding agents affects retention in a preventive dental procedure of pit and fissure sealant. This study will help in deciding whether the self etch bonding agent requiring less steps in completion is as effective as the total etch bonding agent… Read more about this study
- Who is it for?
- Ages 6 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Fissure Sealant Loss
- What is being tested?
- Total etch bonding agent (5th generation) and Self etch (7th generation ) bonding agent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2009to Oct 2009
- Phase
- Phase 2/3
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Fully erupted bilateral first or second permanent molar teeth.
- Patients requiring fissure sealant due high caries risk.
- Age group 6-25 years.
- Occlusal fissures of molar teeth.
Who cannot join
- Cases where one of the molar on either side is grossly carious or restored
- Third molars
- Uncooperative patients
- Molar teeth with antagonist tooth not present or extracted
- Mentally and physically handicapped patients
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
The Aga Khan University Hospital
Karachi, Sindh, 3500
Nadia Aman, BDS, (92)214930051 ext. 5011, nadia.aman@aku.edu
Nadia Aman, BDS
About this study
Official title: Split Mouth Clinical Trial of Fissure Sealant Retention With Self Etching and Total Etch Bonding Agent
The aim of the investigators study is to compare how two different bonding agents affects retention in a preventive dental procedure of pit and fissure sealant. This study will help in deciding whether the self etch bonding agent requiring less steps in completion is as effective as the total etch bonding agent requiring multiple steps in fissure sealant placement.
Read the detailed description
Pit and fissure sealant have been hailed as a highly effective preventive dental treatment since it was introduced first in late 1970s . Sealants have traditionally placed using two step bonding agents based on acid etching with phosphoric acid followed by drying and bonding agent application and curing. Multiple steps in application of bonding agents have been associated with more chances of procedure errors and prolonged procedure time. The newer bonding agents are based on minimizing the number of steps involved with introduction of self etching bonding agents.6th generation adhesives are based on mixing of two components where as the 7th generation adhesives are based on no mix technique.
Previous studies on fissure sealants have focused on conventional etch and rinse bonding agents, there are only few published studies on effectiveness of the self etch bonding agents in retention of fissure sealants in vivo that have targeted the 6th generation adhesive. Feigal and Quelhas reported equivocal results with use of self etching bonding agents in comparison with etch and rinse bonding agents, but their study was limited by smaller sample size. Similar study was conducted by Burbridge which was based on short clinical follow up of 6 month evaluation where Xeno III by Dentsply (6th generation bonding agent) was compared with Prime \& Bond (Dentsply). Another study by Venker et al on Adper Prompt L Pop in a school sealant program was based on retrospective review of cases. In light of published literature on (6th generation) self etch bonding agent has been found to be equal or inferior to total etch bonding agents (5th generation). There are no published clinical trials on the retentiong rate comparison of total etch bonding agent with no mix slef etch bonding agents in pit and fissure sealant.
Our study is based on comparison of effectiveness of single step bonding agent (7th generation adhesives) versus two step bonding agent in fissure sealant retention.
- Conditions
- Fissure Sealant Loss
- Being tested
- Total etch bonding agent (5th generation), Self etch (7th generation ) bonding agent
- Keywords
- fissure sealant, self etch, total etch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total etch bonding agent (5th generation)Other
Also called Adper Single bond 3M ESPE
Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for etch and rinse bonding system (two step bonding agent) will be treated with 37% phosphoric acid (Total Etch Ivoclar Vivadent) for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved.
Adper Single Bond 2 (3M ESPE) will be applied to occlusal fissure using applicator brushes followed by curing for 10 seconds. Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.
Self etch (7th generation ) bonding agentOther
Also called Adper Easy bond 3M ESPE
For teeth selected for application of self etching bonding agent (Adper Easy Bond 3 M), the bonding agent will be applied to occlusal surface with microbrushes and will be left undisturbed for 20 seconds followed by air drying for 5 seconds and then will be light cured for 10 seconds. Fissure sealant (Clinpro 3M ESPE) will be applied in a similar manner as for etch and rinse group and light cured.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | application of total etch bonding agent ( 5th generation) for placement of resing based pit and fissure sealants. Receives: Other: Total etch bonding agent (5th generation) |
| 2 | Experimental | Self etch bonding agent (7th generation) application for placement of resin based pit and fissure sealant Receives: Other: Self etch (7th generation ) bonding agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
fissure sealant loss
Measured: 3months
Secondary outcomes (1)
fissure sealant loss
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fissure Sealant LossStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Investigators
- Nadia Aman, BDS, Principal investigator, The Aga Khan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873990
- Sponsor's protocol ID
- 07GS028SUR
- Acronym
- FSRT
- Status last verified
- Mar 2009
- First submitted
- 1 Apr 2009
- Last updated
- 2 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split Mouth Clinical Trial of Fissure Sealant Retention With Self Etching and Total Etch Bonding Agent
- ClinicalTrials.gov ID
- NCT00873990
- Acronym / sponsor ID
- FSRT / 07GS028SUR
- Conditions
- Fissure Sealant Loss
- Keywords
- fissure sealant, self etch, total etch
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 2 Apr 2009 (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 the investigators study is to compare how two different bonding agents affects retention in a preventive dental procedure of pit and fissure sealant. This study will help in deciding whether the self etch bonding agent requiring less steps in completion is as effective as the total etch bonding agent requiring multiple steps in fissure sealant placement.
Detailed description
Pit and fissure sealant have been hailed as a highly effective preventive dental treatment since it was introduced first in late 1970s . Sealants have traditionally placed using two step bonding agents based on acid etching with phosphoric acid followed by drying and bonding agent application and curing. Multiple steps in application of bonding agents have been associated with more chances of procedure errors and prolonged procedure time. The newer bonding agents are based on minimizing the number of steps involved with introduction of self etching bonding agents.6th generation adhesives are based on mixing of two components where as the 7th generation adhesives are based on no mix technique.
Previous studies on fissure sealants have focused on conventional etch and rinse bonding agents, there are only few published studies on effectiveness of the self etch bonding agents in retention of fissure sealants in vivo that have targeted the 6th generation adhesive. Feigal and Quelhas reported equivocal results with use of self etching bonding agents in comparison with etch and rinse bonding agents, but their study was limited by smaller sample size. Similar study was conducted by Burbridge which was based on short clinical follow up of 6 month evaluation where Xeno III by Dentsply (6th generation bonding agent) was compared with Prime \& Bond (Dentsply). Another study by Venker et al on Adper Prompt L Pop in a school sealant program was based on retrospective review of cases. In light of published literature on (6th generation) self etch bonding agent has been found to be equal or inferior to total etch bonding agents (5th generation). There are no published clinical trials on the retentiong rate comparison of total etch bonding agent with no mix slef etch bonding agents in pit and fissure sealant.
Our study is based on comparison of effectiveness of single step bonding agent (7th generation adhesives) versus two step bonding agent in fissure sealant retention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Total etch bonding agent (5th generation)application of total etch bonding agent ( 5th generation) for placement of resing based pit and fissure sealants. |
| 2 | Experimental | Other: Self etch (7th generation ) bonding agentSelf etch bonding agent (7th generation) application for placement of resin based pit and fissure sealant |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Fully erupted bilateral first or second permanent molar teeth.
- Patients requiring fissure sealant due high caries risk.
- Age group 6-25 years.
- Occlusal fissures of molar teeth.
Key exclusion criteria (5 listed)
- Cases where one of the molar on either side is grossly carious or restored
- Third molars
- Uncooperative patients
- Molar teeth with antagonist tooth not present or extracted
- Mentally and physically handicapped 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 |
|---|---|---|
| Total etch bonding agent (5th generation)Also: Adper Single bond 3M ESPESelected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for etch and rinse bonding system (two step bonding agent) will be treated with 37% phosphoric acid (Total Etch Ivoclar Vivadent) for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved. Adper Single Bond 2 (3M ESPE) will be applied to occlusal fissure using applicator brushes followed by curing for 10 seconds. Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds. | Other | 1 |
| Self etch (7th generation ) bonding agentAlso: Adper Easy bond 3M ESPEFor teeth selected for application of self etching bonding agent (Adper Easy Bond 3 M), the bonding agent will be applied to occlusal surface with microbrushes and will be left undisturbed for 20 seconds followed by air drying for 5 seconds and then will be light cured for 10 seconds. Fissure sealant (Clinpro 3M ESPE) will be applied in a similar manner as for etch and rinse group and light cured. | Other | 2 |
Primary outcome
fissure sealant loss
Time frame: 3months
1 secondary outcome
fissure sealant loss
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2009.
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.
Nadia Aman, BDS principal investigator
The Aga Khan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Total etch bonding agent (5th generation) and Self etch (7th generation ) bonding agent in people with Fissure Sealant Loss, run by Aga Khan University at 1 site in Pakistan.
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 5 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 2 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nadia Aman, BDS ((92)214930051 ext. 5011, nadiaaman79@hotmail.com, nadia.aman@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fissure sealant loss (time frame: 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2009.