The Effect of Antipsychotic Medication and the Associated Hyperprolactinemia as Risk Factor for Periodontal Diseases in Schizophrenic Patients: a Cohort Retrospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fayoum University
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- gingival condition
Study Overview
Brief Summary
The aim of the present cohort retrospective study is to explore the effect of antipsychotics on periodontal health and the possible effect of antipsychotic-induced hyperprolactinemia as a risk factor for periodontal disease progression in schizophrenic patients.
The study population consisted of three groups: Group A (n = 21): schizophrenic patients who have been taking "prolactin inducing" antipsychotics for at least 1 year, Group B (n = 21): schizophrenic patients who have been taking "prolactin sparing" antipsychotics for at least 1 year and Group C (n = 22): newly diagnosed schizophrenic patients and/or patients who did not receive any psychiatric treatment for at least 1 year.
The study groups underwent an assessment of periodontal condition in terms of pocket depth (PD), clinical attachment loss (CAL), gingival recession, tooth mobility, and bleeding on probing (BOP). Also, bone mineral density was evaluated using DEXA scans and the serum prolactin level was measured by automated immunoassay.
Detailed Description
Background and objective: The aim of the present cohort retrospective study is to explore the effect of antipsychotics on periodontal health and the possible effect of antipsychotic-induced hyperprolactinemia as a risk factor for periodontal disease progression in schizophrenic patients.
Methods
- Study design and setting:
The current study is a cohort retrospective study that will be performed on schizophrenic patients. All subjects will be recruited from the outpatient clinic of the department of Psychiatry-Faculty of Medicine- MUST University. The patients' database from the department of psychiatry will be filtered, and all patients with a diagnosis of schizophrenia according to DSM-IV-TR criteria for schizophrenia and fulfilling eligibility criteria will be contacted. Also, outpatients newly diagnosed with schizophrenia will be included. Those who agree to be enrolled in the study will sign a written informed consent. For patients previously diagnosed with schizophrenia, medication data will be acquired from prescription files, including the type and duration of the prescribed antipsychotic or other medications.
Psychiatric assessment and recording of demographic variables such as age, gender, duration of psychiatric disease, and type and duration of antipsychotic medication will be performed by the second investigator (EM.A). Then, all subjects will be referred, with their records and files, to the Faculty of Dentistry at ACU University for periodontal assessment and sample collection. 2. Eligibility criteria:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •with the diagnosis of schizophrenia
- •over 20 years old
- •did not receive any periodontal treatment for the past year
- •with at least 20 remaining teeth.
Exclusion Criteria
- •with systemic condition that may affect periodontal status such as; DM, cardiovascular diseases, metabolic syndrome, osteoporosis, AIDS and chronic alcoholism
- •having local factors that may aggravate and predispose for periodontal diseases such as; orthodontic and prosthetic appliances, parafunctional habits, and heavy smoking
- •receiving any systemic medication and/or systemic antibiotics for the past 6 months.
- •patients undergoing any type of periodontal treatment for the past year and
- •within childhood and adolescence psychiatry section.
Arms & Interventions
Exposure 1
Schizophrenic patients that have been taking antipsychotic drugs inducing hyperprolactinemia (FGAs and the SGAs; amisulpride, risperidone and paliperidone) for at least 1 year
Intervention: antipsychotic drugs inducing hyperprolactinemia (Drug)
Outcomes
Primary Outcomes
gingival condition
Time Frame: 1 months
bleeding on probing (BOP) using scores from 0-3
tooth mobility
Time Frame: 1 months
in mm
Severity of periodontal diseases
Time Frame: 1 months
The primary outcome will be the assessment of periodontal condition in all study groups measured in terms of Pocket depth (PD), clinical attachment loss (CAL) (both measured using graduated periodontal probe in mm)
Secondary Outcomes
- Serum prolactin level(1 months)
Investigators
Rania Hassan Shalby
Lecturer of Oral Medicine
Fayoum University