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comparation of microorganism in patients treated with clear aligners and Fixed metal orthodontic appliances: A prospective study

Comparative evaluation of biofilm microorganisms in patients treated with clear aligners and metal fixed orthodontic appliances: A prospective study. - Nil

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/093054
Enrollment
30
Registered
2025-08-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K088- Other specified disorders of teethand supporting structures Health Condition 2: K088- Other specified disorders of teethand supporting structures

Interventions

Intervention1: nil: nil

Sponsors

Dr Roopa
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient undergoing fixed metal orthodontic appliance treatment and clear aligner treatment. 2.No missing first molars and lateral incisors. No crowns or fixed bridges 3. Healthy subjects without any systemic diseases and no active dental caries, no gingivitis and no periodontitis. Before treatment, patients with periodontal probing depth less than 3mm and no periodontal attachment loss will be included 4. Have good oral hygiene and periodontal health 5. No intake of antibiotics or hormones 1 month before joining the study. 6.The gingival margin of the clear aligner is above the gingiva. 7. One month before baseline examination, all included patients underwent subgingival ultrasonic scaling.

Exclusion criteria

Exclusion criteria: 1 Patient with history of Xerostomia, hyposalivation. 2 Smokers and Pregnant women. 3 Subjects under any medications that could affect the antibiotic sensitivity during the previous six months before joining to study. 4 Patients who are under analgesic medication or NSAIDs will be excluded. 5 Cleft palate and cleft lip patients 6 Patients with ceramic brackets were excluded. 7 Due to ongoing H3N2outbreak, subjects with cough, cold, sore throat, breathlessness, fever or COVID symptoms will be excluded.

Design outcomes

Primary

MeasureTime frame
The awareness and understanding of oral hygiene aspects during orthodontic treatment using different appliances like metal fixed appliances, clear aligners will help the clinician to make a decision on the choice of orthodontic appliance for treating patients in a better manner with less adverse effects on gingival and periodontal health.Timepoint: at baseline(t1) , 6 months (t2)

Secondary

MeasureTime frame
To evaluate and compare the plaque and gingival indices during treatment with metal fixed appliances and clear aligners.Timepoint: two time points: Before orthodontic treatment (T0) and 6 months (T1).

Countries

India

Contacts

Public ContactDr Roopa

SDM College of Dental Sciences and Hospital Shri Dharmasthala Manjunatheshwara University

drshrinivas6@gmail.com9449824324

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026