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Effect of aripiprazole oral disintegrating tablets on oral health and oral microbiome in patients with schizophrenia: a randomized controlled trial

Effect of aripiprazole oral disintegrating tablets on oral health and oral microbiome in patients with schizophrenia: a randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056872
Enrollment
Unknown
Registered
2022-02-22
Start date
2022-02-22
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Schizophrenia

Interventions

Control group:Aripiprazole oral tablet
Experimental group:Aripiprazole orally disintegrating tablet

Sponsors

Huizhou Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients with schizophrenia (18 years old <60 years old), no gender limit; 2. Meet the ICD-10 F20 diagnostic criteria for schizophrenia; 3. Aripiprazole is to be prescribed (single drug or combined with other drugs); 4. The patient or legal guardian should fully understand the treatment and agree to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Had dental cleaning, oral surgery, orthodontic and other operations in the past 3 months; 2. Use antibiotics orally or orally within the past 1 month; 3. Used aripiprazole in the past 3 months; 4. Combined with serious oral diseases: such as severe congenital oral malformations, oral cancer, etc.; 5. Severe or unstable immune or inflammatory diseases; 6. Unable to cooperate with oral sample sampling; 7. Failure to follow the study protocol.

Design outcomes

Primary

MeasureTime frame
Oral health scale;Oral microbiome;

Secondary

MeasureTime frame
Clinical indicators of oral health;Positive and negative symptom scales;

Countries

China

Contacts

Public ContactHuang Huawei

Huizhou Second People's Hospital

5855833@qq.com+86 15917759418

Outcome results

None listed

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