One Year Clinical Evaluation of White Spot Lesions Treated With Newly Introduced Resin Modified Glass Ionomer in Comparison to Resin Infiltration in Anterior Teeth Split Mouth Technique

NCT02912741 | Unknown Phase 2 DMC

• 1 other identifier: CEBD-CU-2016-09-209
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to evaluate the addition of new technology of resin modified glass-ionomer in comparison to resin infiltration in treating post-orthodontic white spot lesions; both applies into the same patient's mouth; to reveal which material will have more clinical satisfactory performance inside the oral cavity and to overcome the high expensive cost in treating such clinical cases

Conditions

White Spot Lesions

Outcome Measures

Primary Outcomes (1)

• Change in Patient satisfaction

  using visual analogue scale ruler (0-100 mm) 0 refer to not satisfied at all,100 refer to total satisfied

  immediately, 1 day, 1week,1 month,3 month,6 month and1 year

Secondary Outcomes (1)

• Change in color change

  immediately, 1 day, 1week,1 month,3 month,6 month and1 year

Other Outcomes (1)

• Change in caries lesion state

  immediately, 1 day, 1week,1 month,3 month,6 month and1 year

Study Arms (2)

Vanish xt Extended Contact Varnish

EXPERIMENTAL

Vanish xt Extended Contact Varnish is a resin modified glass ionomer cement and fluoride varnish used to treat white spot lesions to be more resistant to early caries progression.

Drug: Vanish xt Extended Contact Varnish

Resin infiltration

ACTIVE COMPARATOR

Resin infiltration is a low viscous resin infiltrates into small pores of white spot lesions to block entrance of bacteria into dentinal tubules of the tooth and more resistant to early caries progression.

Drug: resin infiltration

Interventions

Vanish xt Extended Contact Varnish DRUG

resin modified glass- ionomer cement varnish applied as a thin layer coating and cured

Also known as: Clinpro xt

Vanish xt Extended Contact Varnish

resin infiltration DRUG

low viscous light cure resin applied in layers and cured

Also known as: ICON

Resin infiltration

Eligibility Criteria

• Age: Up to 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Post-Orthodontic patients included in this clinical trial toll age of 35 years.
• Patients with good general health.
• Patients who will agree to the consent and will commit to follow-up period.
• Fully erupted anterior teeth with no cavitated lesions.
• At least one spot lesion on each side in the same jaw

You may not qualify if:

• Patients with any systemic disease that may affect normal healing.
• Patient with bad oral hygiene.
• Tetracycline or fluorsis staining.
• Patients who could/would not participate in all times of follow-up.
• Untreated periodontal disease was not allowed.
• Active caries or defective Restorations in 6 anterior teeth.
• Bleaching history
• Patients participating in more than 1 dental study.
• Patient received fluoride varnish during orthodontic treatment.

Sponsors & Collaborators

• Cairo University: lead

Study Officials

• Ahmed Elkhadem, PhD

  Cairo University

  STUDY CHAIR

Central Study Contacts

Shaimaa Mohammed Rohym, Master

CONTACT

01007374670; drshdentist@hotmail.com

Asmaa Harhash, PHD

CONTACT

01223325740; asmaaharhash@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Air-Force Specialized Hospital, New Cairo

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 23, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 23, 2016

Record last verified: 2016-09