Clinical trial NCT00873990: Fissure Sealant Retention Trial
Official title: Split Mouth Clinical Trial of Fissure Sealant Retention With Self Etching and Total Etch Bonding Agent
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Fissure Sealant Loss
Keywords: fissure sealant
self etch
total etch
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 93
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: fissure sealant loss
timeFrame: 3months
Secondary outcomes:
measure: fissure sealant loss
timeFrame: 6months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Aga Khan University Hospital
state: Sindh
Study officials:
affiliation: The Aga Khan University Hospital
name: Nadia Aman, BDS
role: PRINCIPAL_INVESTIGATOR
References: