Antipsychotic Induced Hyperprolactinemaia as Risk Factor for Periodontitis in Schizophrenic Patients

NCT06040944 | Completed DMC FDA Drug

• 1 other identifier: 19038219038211011
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Periodontal Diseases

Keywords

schizophrenia; antipsychotics; periodontal disease; hyperprolactinemia

Outcome Measures

Primary Outcomes (3)

• Severity of periodontal diseases

  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)

  1 months

• gingival condition

  bleeding on probing (BOP) using scores from 0-3

  1 months

• tooth mobility

  in mm

  1 months

Secondary Outcomes (1)

• Serum prolactin level

  1 months

Study Arms (3)

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

Drug: antipsychotic drugs inducing hyperprolactinemia

Exposure 2

Schizophrenic patients that have been taking antipsychotics sparing hyperprolactinemia (In SGAs; clozapine, quetiapine, olanzapine, ziprasidone and aripiprazole) for at least 1 year

Non exposure (basline)

Newly diagnosed schizophrenic patients and/ or patients did not receive any psychiatric treatment for at least 1 year

Interventions

antipsychotic drugs inducing hyperprolactinemia DRUG

not exposed

Also known as: antipsychotic drugs not inducing hyperprolactinemia

Exposure 1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

diagnosis of schizophrenia according to DSM-IV-TR criteria for schizophrenia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Rania Hassan Shalby

Giza, Egypt

Location

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Periodontal Diseases; Schizophrenia; Hyperprolactinemia

Condition Hierarchy (Ancestors)

Mental Disorders; Mouth Diseases; Stomatognathic Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Rania H Shalby, phd

  Faculty of Dentistry-Fayoum University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral Medicine

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: September 18, 2023
• Study Start: September 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)