Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03217084
Other study ID # FODM CU
Secondary ID
Status Recruiting
Phase Phase 4
First received July 12, 2017
Last updated February 4, 2018
Start date December 17, 2017
Est. completion date December 2018

Study information

Verified date February 2018
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Dental caries is the destruction of the tooth structure in the presence of organic acids produced by cariogenic bacteria located in the dental biofilm (Dowker et al., 1999 and Robinson et al., 2000).Tooth enamel comprises 90% substituted hydroxyapatite (Ca10 (PO4)6(OH) 2), which is subjected to consecutive cycles of demineralization and remineralization. This is an interrupted process, with periods of remineralization and demineralization occurring, depending on the state of the oral environment in terms of the prolonged accumulation and retention of bacterial plaque on the enamel surface (Aoba, 2004).

Oral bacteria ferment carbohydrates to produce organic acids which lower the pH and cause the subsurface dissolution of the hydroxyapatite crystals. Under normal physiological conditions (pH7), saliva is supersaturated with calcium and phosphate ions which diffuse into the vacancies created during acid-mediated demineralization episodes (Dowker et al., 1999 and Robinson et al., 2000). The demineralization of enamel (white spot lesions) is a significant problem during and after orthodontic treatment with prevalence 71.1% and various preventive measures have been suggested to minimize the incidence (Derks et al., 2004 and Al Maaitah et al., 2011).


Description:

In orthodontic patients, demineralization usually takes place in the form of white or brown spots on the enamel around the brackets and can lead to cavitation (Al Maaitah et al., 2011). White spot lesions compromise esthetics and can be extremely difficult or even impossible to reverse.

Natural remineralization through saliva involving a mineral gain in the surface layer of white spot lesions has little improvement on the esthetic and structural properties of the deeper lesions (Karlinsey et al., 2009 and Cochrane et al., 2010). Management of white spot lesion should involve methods of both preventing demineralization and encourage the remineralization of existing lesions. In both of these processes, the efficacy of fluoride is well established. Fluoride increases the initial rate of remineralization of early enamel lesions. Consequently, it slows down the caries process and arresting the lesion. Fluoride varnish provides a protective coat over the tooth which adheres longer to the tooth surface (Demito et al., 2004 and Ten Cate et al., 2008).


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 2018
Est. primary completion date September 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 16 Years
Eligibility Inclusion Criteria:

1. Age ranging 11-16 years.

2. Good general health.

3. Exhibiting at least 2 white spot lesion in buccal surface of their teeth.

Exclusion Criteria:

1. Chronic use of medication causing dry mouth.

2. Oral ulcer, ulcerous gingivitis, acute bronchial asthma.

3. History of allergic reaction to fluoride or other ingredients in varnish.

4. Refusal of the patient to participate in the trial.

5. Any previous treatment done for white spot lesion.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MI varnish GC
MI Varnish GC is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. MI Varnish also contains RECALDENT. Open the unit-dose package of Varnish. Use the applicator brush to thoroughly mix Varnish. Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue. The treatment period for Varnish is minimally 4 hour.
White varnish 3M
White varnish 3M is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. Clinpro White Varnish contains an innovative tri-calcium phosphate.Open the unit-dose package of Varnish and dispense the entire content onto the round application guide provided with the packet. Use the applicator brush to thoroughly mix Varnish. Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue. The treatment period for Varnish is minimally 4 hour.

Locations

Country Name City State
Egypt Faculty of Dentistry Cairo University Al Manyal Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Photography Enamel decalcification index by score 6 months
Primary Esthetic effect Asking patient (yes or No) 6 months
Secondary Clinical assessment International Caries Detection and Assessment System (ICDAS II) by score 6 months
See also
  Status Clinical Trial Phase
Completed NCT03004196 - Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce S.Mutans Phase 1/Phase 2
Terminated NCT04827966 - Remineralization Agents for the Treatment of White Spot Lesions N/A
Not yet recruiting NCT03973554 - Caries Prevention Potential of Pearl Powder Versus CPP-ACP on Enamel White Spot Lesions Phase 2
Completed NCT05757440 - Effect of Low-viscosity Resin Infiltration on Color Change of Enamel White Spot Lesions N/A
Completed NCT05871619 - Combined Application of Diode Laser and Different Remineralizing Agents on White Spot Lesions N/A
Not yet recruiting NCT03930927 - Effect of Self Assembling Peptide on White Spot Lesion Early Phase 1
Not yet recruiting NCT03721198 - RMGI Varnish Versus APF Gel in Prevention of White Spot Lesions During Orthodontic Treatment N/A
Completed NCT03526276 - Effect of Different Pastes on Remineralization of Early Caries Lesions in Primary Teeth N/A
Recruiting NCT03823612 - Reminerlization Potential of Innovative Biomimetic Material in Caries White Spot Lesions Phase 4
Recruiting NCT05206539 - Efficacy of Different Agents in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children Phase 3
Completed NCT04401280 - Bioactive Glass in the Treatment of Enamel White Spot Lesions Phase 3
Completed NCT03738839 - A Comparative Assessment of Orthodontic Treatment Outcomes Using the Quantitative Light-Induced Fluorescence Method N/A
Recruiting NCT04994314 - White Spot Lesions Prevention During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial Phase 3
Completed NCT04992481 - Fluoride Varnish, Ozone, Octenidin and WSLs in Orthodontic Patients N/A
Active, not recruiting NCT05764187 - Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets N/A
Recruiting NCT06402500 - Color Masking Potential of Bioactive and ICON Materials N/A