Comparison of Erythritol Air-Polishing and Conventional Polishing Following Ultrasonic Scaling on the Relapse of Chromogenic Tooth Staining in Children: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Marmara University
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Black Stain Score
Study Overview
Brief Summary
The goal of this randomized clinical trial is to compare the effect of erythritol air-polishing and conventional polishing following ultrasonic scaling on the relapse of chromogenic tooth staining in children aged 4-13 years attending the Pediatric Dentistry Clinic of Marmara University Faculty of Dentistry for routine dental examination.
The main questions this study aims to answer are:
- Does erythritol air-polishing reduce the relapse of chromogenic tooth staining compared with conventional polishing following ultrasonic scaling?
- Is there a difference in the time to relapse of chromogenic tooth staining between the two polishing techniques?
Researchers will compare conventional polishing (prophylaxis paste and a polishing brush) following ultrasonic scaling with erythritol air-polishing performed using the EMS air-polishing device following ultrasonic scaling to determine whether one method is more effective in preventing or delaying the relapse of chromogenic tooth staining.
Detailed Description
Participants will:
Undergo a routine oral examination. Receive professional removal of chromogenic tooth staining using ultrasonic scaling.
Be randomly assigned to receive either conventional polishing with prophylaxis paste and a polishing brush or erythritol air-polishing using the EMS air-polishing device.
Attend follow-up visits to assess the recurrence of chromogenic tooth staining over time.
Chromogenic tooth staining will be assessed using the Qraycam.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children aged 4-13 years.
- •Absence of oral diseases, including gingivitis and oral mucosal diseases.
- •No orthodontic appliances.
- •No history of iron supplementation or professional fluoride treatment within the previous 3 months.
- •Systemically healthy children.
Exclusion Criteria
- •Presence of oral diseases, including periodontitis, salivary gland diseases, or oral mucosal diseases.
- •History of autoimmune disease.
- •Antibiotic use within the previous 3 months.
- •Consumption of tannin-containing beverages (e.g., tea, coffee, or similar beverages) within the previous 1 month.
Outcomes
Primary Outcomes
Black Stain Score
Time Frame: Baseline, immediately after polishing, 1 month, 2 months, 3 months, and 6 months
Black Stain Classification (Gasparetto et al., 2003) Score Description Clinical Characteristics 0 None No black pigmentation on the tooth surface. 1. Mild Pigmented dots or thin pigmented lines parallel to the gingival margin that are not continuous. 2. Moderate Continuous pigmented lines o extending over up to one-half of the cervical third of the tooth surface. 3. Severe Pigmentation extending over more than one-half of the cervical third of the tooth surface. Black Stain Classification (Zerman et al., 2024) Score Description A Pigmented lines or dots present only on the buccal surface. B Pigmented lines or dots present on both the buccal and lingual surfaces. C Pigmented lines or dots associated with dental caries. D Recurrent pigmented lines or dots.
Participant Feedback
Time Frame: Periprocedural
Pain perception during the procedure will be assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "hurts worst." Higher scores indicate greater pain intensity (worse outcome).
Time Session
Time Frame: Periprocedural
The duration of treatment is noted and compared between groups
Secondary Outcomes
No secondary outcomes reported