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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

Double Blinded Randomized Clinical Trial for Evaluation of Resin Modified Glass Ionomer Cement Versus Resin Infiltration in Treating White Spot Lesions

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02912741
Enrollment
35
Registered
2016-09-23
Start date
2017-01-31
Completion date
2018-05-31
Last updated
2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesions

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

Detailed description

Roles and responsibilities: * Shaimaa Mohammed (SH.M.): Operator and author.Specialist in Air-Force Specialized Hospital. * Mohamed Riad (M.R.): Main supervisor, data monitoring and auditing, Professor, Conservative Dentistry Department,Cairo University. * Asma Harhash(A.H.):Co-supervisor, outcome assessor and data collection, Associate Professor, Russian University. * Omnia Magdy Moustafa (O.M.): Baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents: Assistant lecturer, Conservative Dentistry Department , Faculty of Oral and Dental Medicine Cairo University. * Ghada Ahmed (G.A.): Data entry and auditing; Assistant lecturer, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Russian University. Intervention: A- Preoperative clinical assessment: 1. Explain patient need toward aesthetic needs 2. Digital photos for white spot lesions 3. Recording number of white spot lesions and site. (SH.M.) will apply both materials at the same patient mouth (Split mouth technique) according to the manufacturer's instructions. * Intervention: resin modified glass ionomer cement varnish: Vanish™ xt Extended Contact Varnish (3M ESPE Dental) * Comparator: resin infiltration (Dental Milestones Guaranteed, Germany). (A.H) and (SH.M) will assess the outcome measures through the follow up time: immediately after,1 day, 1 week,1 month,3 months, 6 months, 12 months

Interventions

DRUGVanish xt Extended Contact Varnish

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

DRUGresin infiltration

low viscous light cure resin applied in layers and cured

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 35 Years
Healthy volunteers
Yes

Inclusion criteria

1. Post-Orthodontic patients included in this clinical trial toll age of 35 years. 2. Patients with good general health. 3. Patients who will agree to the consent and will commit to follow-up period. 4. Fully erupted anterior teeth with no cavitated lesions. 5. At least one spot lesion on each side in the same jaw

Exclusion criteria

1. Patients with any systemic disease that may affect normal healing. 2. Patient with bad oral hygiene. 3. Tetracycline or fluorsis staining. 4. Patients who could/would not participate in all times of follow-up. 5. Untreated periodontal disease was not allowed. 6. Active caries or defective Restorations in 6 anterior teeth. 7. Bleaching history 8. Patients participating in more than 1 dental study. 9. Patient received fluoride varnish during orthodontic treatment.

Design outcomes

Primary

MeasureTime frameDescription
Change in Patient satisfactionimmediately, 1 day, 1week,1 month,3 month,6 month and1 yearusing visual analogue scale ruler (0-100 mm) 0 refer to not satisfied at all,100 refer to total satisfied

Secondary

MeasureTime frameDescription
Change in color changeimmediately, 1 day, 1week,1 month,3 month,6 month and1 yearusing vita easy shade device

Other

MeasureTime frameDescription
Change in caries lesion stateimmediately, 1 day, 1week,1 month,3 month,6 month and1 yearDiagnodent device

Contacts

Primary ContactShaimaa Mohammed Rohym, Master
drshdentist@hotmail.com01007374670
Backup ContactAsmaa Harhash, PHD
asmaaharhash@yahoo.com01223325740

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026