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Treatment of Postorthodontic White Spot Lesions

Primary Purpose

White Spot Lesion of Tooth

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
MI varnish GC
White varnish 3M
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for White Spot Lesion of Tooth focused on measuring White spot lesion ,fluoride varnish

Eligibility Criteria

11 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Dentistry Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MI varnish GC

White Varnish 3M

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Esthetic effect
Asking patient (yes or No)

Secondary Outcome Measures

Clinical assessment
International Caries Detection and Assessment System (ICDAS II) by score

Full Information

First Posted
July 12, 2017
Last Updated
February 4, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03217084
Brief Title
Treatment of Postorthodontic White Spot Lesions
Official Title
Esthetic Effect of Casein Phosphopeptide-Amorphous Calcium Phosphate Varnish Versus Tricalcium Phosphate Varnish on Postorthodontic White Spot Lesions: A Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 17, 2017 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
White Spot Lesion of Tooth
Keywords
White spot lesion ,fluoride varnish

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MI varnish GC
Arm Type
Active Comparator
Arm Description
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.
Arm Title
White Varnish 3M
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MI varnish GC
Other Intervention Name(s)
Fluoride Varnish
Intervention Description
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
Intervention Name(s)
White varnish 3M
Other Intervention Name(s)
Fluoride Varnish
Intervention Description
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.
Primary Outcome Measure Information:
Title
Esthetic effect
Description
Asking patient (yes or No)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical assessment
Description
International Caries Detection and Assessment System (ICDAS II) by score
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Photography
Description
Enamel decalcification index by score
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ranging 11-16 years. Good general health. Exhibiting at least 2 white spot lesion in buccal surface of their teeth. Exclusion Criteria: Chronic use of medication causing dry mouth. Oral ulcer, ulcerous gingivitis, acute bronchial asthma. History of allergic reaction to fluoride or other ingredients in varnish. Refusal of the patient to participate in the trial. Any previous treatment done for white spot lesion.
Facility Information:
Facility Name
Faculty of Dentistry Cairo University
City
Al Manyal
State/Province
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelrahman Al-Duqi, Bsc
Phone
+201145511131
Email
abdulrahman.alduqi@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Fatma Abdelgawad, PhD
Phone
±201006753265
Email
fatmadent@hotmail.com
First Name & Middle Initial & Last Name & Degree
Abdelrahman Al-Duqi, Bsc
First Name & Middle Initial & Last Name & Degree
Fatma Abdelgawad, PhD
First Name & Middle Initial & Last Name & Degree
Nevine Waly, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Treatment of Postorthodontic White Spot Lesions

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