The Effectiveness of Biomimetic Materials in Preventing Enamel Demineralization During Fixed Orthodontic Treatment

July 3, 2023 updated by: Samar Husam Assim, University of Baghdad

The Effectiveness of Biomimetic Materials in Preventing Enamel Demineralization During Fixed Appliance Orthodontic Treatment: a Randomized Clinical Trial

This study will be done to evaluate the impact of Biosmalto Impact Action Mousse™ on the development and healing of WSLs in individuals receiving orthodontic treatment.

The control group received a fluoridated toothpaste (Colgate toothpaste). The intervention group received Curasept toothpaste and additionally at each visit a Curasept Biosmalto Mousse was applied on the facial surface of the maxillary and mandibular anterior teeth using a tray.

For each patient recruited, identical toothbrushes and oral care instructions were given. The patients received instructions to brush their teeth for at least two minutes using an up-down motion on their anterior teeth and a circular motion on their posterior teeth at least three times/day.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter randomized clinical trial with blinded parallel groups, simple randomization, an equal allocation ratio (1:1), and no stratification.The patients will be initially assessed for eligibility to be included in the study by the investigator.The study was verbally explained to those who fulfilled the inclusion criteria in order to get their first consent for participation. After that, they received the patient information sheet (Appendix), which explained the purpose of the research. The patients were instructed to thoroughly read the informational material at home and tell the researcher of their intention to participate at the next visit. Participants had to either sign the consent form (which was attached to the patient information sheet) or get their parents' permission (if the participant was under the age of 18 years). The investigator provided the patients with further information or reassurance about the trial if needed.

All the participants received a standardized treatment protocol. The patients were treated with straight wire appliance using metal brackets (3BOrtho, China). Initially, teeth polishing was performed with pumice and rubber cup for 10 seconds using a low-speed handpiece, followed by water rinsing and air drying (oil-free air spray for 30 seconds). Bonding technique was performed using 37% phosphoric acid for 30 seconds (Heinig and Hartmann, 2008b), then washed with water for 15-20 seconds, and dried for 10 seconds. A thin coat of primer was applied to the etched surfaces by an applicator and cured for 15 seconds by the LED light-curing unit. The brackets were bonded using similar adhesive (3B Ortho, white glue, China) and checked so that no obvious extra adhesive is remained on the tooth surface around the brackets. The control group received a fluoridated toothpaste (Colgate toothpaste). The intervention group received Curasept toothpaste and additionally at each visit a Curasept Biosmalto Mousse was applied on the facial surface of the maxillary and mandibular anterior teeth using a tray.

For each patient recruited, identical toothbrushes and oral care instructions were given. The patients received instructions to brush their teeth for at least two minutes using an up-down motion on their anterior teeth and a circular motion on their posterior teeth at least three times/day. Additionally, the patients were instructed not to use any additional antimicrobial-containing products (mouthwash, toothpaste, gel).

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Baghdad, Iraq
        • Samar Husam Assim Alkhdhairi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Willingness to participate.
  • No underlying medical conditions requiring medications that may cause dryness of the mouth.
  • Fully erupted permanent maxillary and mandibular canines and incisors that have not been restored.

Exclusion Criteria:

  • Receiving professional fluoridation within the last three months.
  • Untreated cavitated lesions or significant restorations on the facial surfaces of study teeth.
  • Labial restoration of any of the study teeth.
  • Missing any of the study teeth.
  • Severely rotated any of the study teeth (limiting the appearance of buccal surfaces).
  • Patients with enamel hypoplasia, dental fluorosis or tetracycline pigmentation.
  • Dental anomalies related to morphology, anatomy, or development.
  • Pregnancy and xerostomia.
  • Heavy smokers.
  • Craniofacial syndromes such as clefts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
The intervention group will receive Curasept toothpaste with instructions and additionally at each visit a Curasept Biosmalto Mousse will be applied on the facial surface of the maxillary and mandibular anterior teeth using a tray.
Combination product: Curasept Biosmalto Mousse and toothpaste
at each visit a Curasept Biosmalto Mousse will be applied on the facial surface of the maxillary and mandibular anterior teeth using a tray.
Placebo Comparator: control group
The control group will receive a fluoridated toothpaste (Colgate toothpaste) and instructed to brush at least three times/day.
Other: Colgate toothpaste
The control group will receive a fluoridated toothpaste (Colgate toothpaste)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WSLs evaluation
Time Frame: 6 month

To evaluate the number of WSLs on the labial surfaces of maxillary and mandibular anterior teeth using enamel white spot lesion index (WSLI), ICDAS (International caries detection and assessment system) and DIAGNOdent pen scores at each visit and after six months during orthodontic treatment.

Gorelick Index :

0: no WSLs

  1. Slight WSLs
  2. extended or excessive WSLs
  3. WSLs with cavitation

DIAGNOdent pen reading:

0 - 10 Healthy Tooth Structure 11-20 Outer Half Enamel Caries 21-30 Inner Half Enamel Caries 30+ Dentin Caries
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of plaque and gingival bleeding
Time Frame: 6 month

To evaluate the amount of plaque and gingival bleeding by using visible plaque index (VPI) gingival bleeding index (GBI) at each visit (4-6 weeks) Visible plaque index (VPI) 0: non-visible plaque 1: visible plaque Gingival bleeding index (GBI) 0: no gingival bleeding

1: gingival bleeding
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

June 25, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 763423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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