Fissure Sealant Retention Trial

NCT00873990 | Unknown Phase 2 DMC

• 1 other identifier: 07GS028SUR
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Fissure Sealant Loss

Keywords

fissure sealant; self etch; total etch

Outcome Measures

Primary Outcomes (1)

• fissure sealant loss

  3months

Secondary Outcomes (1)

• fissure sealant loss

  6months

Study Arms (2)

1

ACTIVE COMPARATOR

application of total etch bonding agent ( 5th generation) for placement of resing based pit and fissure sealants.

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

Other: Self etch (7th generation ) bonding agent

Interventions

Total etch bonding agent (5th generation) OTHER

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.

Also known as: Adper Single bond 3M ESPE

1

Self etch (7th generation ) bonding agent OTHER

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.

Also known as: Adper Easy bond 3M ESPE

2

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

The Aga Khan University Hospital

Karachi, Sindh, 3500, Pakistan

RECRUITING

Study Officials

• Nadia Aman, BDS

  The Aga Khan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Aman, BDS

CONTACT

(92)214930051; nadiaaman79@hotmail.com, nadia.aman@aku.edu

Farhan R Khan, FCPS

CONTACT

(92)214930051; farhan.raza@aku.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 2, 2009

Record last verified: 2009-03

Locations

PA (1)