Fissure Sealant Loss Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02998814 -
Clinical Follow Up of a Fissure Sealant Placed With Different Adhesive Protocols: 2-Year Randomized Split Mouth Study
|
N/A |