Treatment of Postorthodontic White Spot Lesions

NCT ID: NCT03217084

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-17
• Study Completion Date: 2018-12-31

Brief 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).

Detailed 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).

Conditions

White Spot Lesion of Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MI varnish GC

MI Varnish is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. MI Varnish also contains RECALDEN 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.

Group Type: ACTIVE_COMPARATOR

MI varnish GC

Intervention Type: DRUG

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 is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. White Varnish an innovative tri-calcium phosphate.

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.

Group Type: ACTIVE_COMPARATOR

White varnish 3M

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Fluoride Varnish; Fluoride Varnish

Eligibility Criteria

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrahman Yousef ALduqi

Master degree student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry Cairo University

Al Manyal, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Abdelrahman Al-Duqi, Bsc

Role: primary

abdulrahman.alduqi@dentistry.cu.edu.eg

+201145511131

Fatma Abdelgawad, PhD

Role: backup

fatmadent@hotmail.com

±201006753265

Other Identifiers

FODM CU

Identifier Type: -

Identifier Source: org_study_id