Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06040944
Status:
COMPLETED
Last Update Posted:
2023-09-18
First Post:
2023-03-10
Brief Title:
Antipsychotic Induced Hyperprolactinemaia as Risk Factor for Periodontitis in Schizophrenic Patients
Sponsor:
Fayoum University
Organization:
Fayoum University
Study Overview
Official Title:
The Effect of Antipsychotic Medication and the Associated Hyperprolactinemia as Risk Factor for Periodontal Diseases in Schizophrenic Patients a Cohort Retrospective Study
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 andor 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
1 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 EMA 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
The included patients are those 1 with the diagnosis of schizophrenia 2 over 20 years old 3 who did not receive any periodontal treatment for the past year and 4 with at least 20 remaining teeth To avoid potential confounding factors the excluded patients are 1 those with systemic conditions that may affect periodontal status such as DM CVS metabolic syndrome osteoporosis AIDS and chronic alcoholism 3 4 17 2 those with local factors that may aggravate and predispose for periodontal diseases such as orthodontic and prosthetic appliances parafunctional habits and heavy smoking 4 23-25 and 3 those receiving any systemic medication andor systemic antibiotics for the past 6 months Additionally exclusion criteria involved 4 patients undergoing any type of periodontal treatment for the past year 5 patients within the childhood and adolescent psychiatry section and 6 patients who received antipsychotic medication for 12 months
3 Estimating the sample size
The sample size was calculated considering type I error α of 005 and power 1-β of 09 Based on a previous study by 16 that used proportions inequality and two independent groups Fishers exact test to compare patients with a pocket depth of 4 mm to those with no pocket depth identified in patients receiving antipsychotics 12 months with effect size the sample size was calculated and found to be a total of 64 patients The application GPower 3197 16 was used to determine the sample size needed for the study
4 Participants
The study population will be divided into three groups Exposure groups will be divided according to their prolactin-inducing or prolactin sparing effect 26-36 Group A n 21 schizophrenic patients that have been taking antipsychotic medication that may induce hyperprolactinemia FGAs and SGAs amisulpride risperidone and paliperidone for at least 1 year group B n 21 schizophrenic patients who have been taking antipsychotics that do not have a significant effect on serum prolactin levels in SGAs clozapine quetiapine olanzapine ziprasidone and aripiprazole for at least 1 year and Group C n 22 newly diagnosed schizophrenic patients andor patients who did not receive any psychiatric treatment for at least 1 year
4 Outcome measurements The primary outcome was the assessment of periodontal condition in all study groups measured in terms of pocket depth PD tooth mobility clinical attachment loss CAL gingival recession and bleeding on probing BOP while the secondary outcomes were evaluation of BMD and the serum prolactin level measured by automated immunoassay in ngml
6Assessment of clinical data and patient condition Assessment of mental health The Positive and Negative Syndrome Scale PNSS 37 was used to evaluate each patients clinical history and current mental health state
Periodontal evaluation
All teeth were evaluated and recorded The means for the following parameters were computed pocket depth PD clinical attachment loss CAL and bleeding on probing BOP 38 39 Using a manual periodontal probe Williams periodontal probe PCP-12 Hu-Friedy Chicago IL USA PD and CAL measurements were collected on six surfaces per tooth mesio-buccal mid-buccal disto-buccal and mesio-lingual mid-lingual disto-lingual or palatal surfaceWhile CAL measures the distance between the cement-enamel junction of the tooth and the deepest aspect of the pocket probing pocket depth measures the distance between the gingival margin and the deepest part of the pocket Total mean PD of the six locations for each tooth was computed for each patient and distance was recorded to the nearest millimeter 40 Sulcus depths between 0 and 2 mm were regarded as normal 41 Gingival recession was measured from the CEJ to the marginal border of the soft tissue on the buccal and lingual sides of each tooth The total mean number of recessions per tooth for each patient was used to record tooth recessions Gingival recession if present was only used to calculate CAL by its addition to PD
Four surfaces per tooth were examined for BOP readings mesial distal buccal and lingual or palatal surface Bleeding on probing was examined directly after the PD measurement and was reported as absent 0 or present 1 30 seconds after applying the periodontal probe The proportion of teeth displaying BOP was recorded
Generalized mild periodontitis is defined as 30 of remaining teeth with PD 5 mm and 7 mm as per the 2015 Update to the 1999 Classification of Periodontitis Severe periodontitis was defined as a probing depth PD of 7 mm with localised periodontitis involving 30 of remaining teeth and generalised periodontitis involving 30 of remaining teeth 42
Assessment of bone mineral density
Dual-energy X-ray absorptiometry DEXA scan is an advanced technology that could detect bone mineral density The GE Lunar Prodigy densitometer was used to perform this testTo determine what constitutes healthy bone we utilized the World Health Organizations criteria a T score of -1 indicates normal bone a T score between -1 and -25 indicates osteopaenia and a T score of -25 indicates osteoporosis
Measurement of serum prolactin level
Blood will be withdrawn from all patients to determine the fasting serum prolactin level Prolactin concentrations in blood will be measured in a faculty laboratory by automated immunoassay methodology 43
7 Data collection and management Periodontal assessment will be carried out by the primary investigator SR who will be unaware of the patients psychological status and records to avoid potential bias The third investigator MC will collect all patient records to perform the final analysis
STATISTICAL METHODS
Quantitative continuous variables were expressed as mean SD As the quantitative variables were not normally distributed the Kruskal-Wallis test a non-parametric test was used to compare them among the 3 study groups A post hoc analysis was done for variables that showed a statistically significant difference in the Kruskal-Wallis test using Dwass-Steel-Critchlow-Fligner pairwise comparisons As for qualitative variables categorical the chi-square test was used to compare them among the 3 study groups and values were expressed as percentages Also linear regression analysis was performed to study the relation between 2 quantitative variables serum prolactin level and PD measurements while ordinal logistic regression was used to relate one quantitative serum prolactin level and one qualitative BMD or grades of periodontitis variables
Methods
1 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 EMA 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
The included patients are those 1 with the diagnosis of schizophrenia 2 over 20 years old 3 who did not receive any periodontal treatment for the past year and 4 with at least 20 remaining teeth To avoid potential confounding factors the excluded patients are 1 those with systemic conditions that may affect periodontal status such as DM CVS metabolic syndrome osteoporosis AIDS and chronic alcoholism 3 4 17 2 those with local factors that may aggravate and predispose for periodontal diseases such as orthodontic and prosthetic appliances parafunctional habits and heavy smoking 4 23-25 and 3 those receiving any systemic medication andor systemic antibiotics for the past 6 months Additionally exclusion criteria involved 4 patients undergoing any type of periodontal treatment for the past year 5 patients within the childhood and adolescent psychiatry section and 6 patients who received antipsychotic medication for 12 months
3 Estimating the sample size
The sample size was calculated considering type I error α of 005 and power 1-β of 09 Based on a previous study by 16 that used proportions inequality and two independent groups Fishers exact test to compare patients with a pocket depth of 4 mm to those with no pocket depth identified in patients receiving antipsychotics 12 months with effect size the sample size was calculated and found to be a total of 64 patients The application GPower 3197 16 was used to determine the sample size needed for the study
4 Participants
The study population will be divided into three groups Exposure groups will be divided according to their prolactin-inducing or prolactin sparing effect 26-36 Group A n 21 schizophrenic patients that have been taking antipsychotic medication that may induce hyperprolactinemia FGAs and SGAs amisulpride risperidone and paliperidone for at least 1 year group B n 21 schizophrenic patients who have been taking antipsychotics that do not have a significant effect on serum prolactin levels in SGAs clozapine quetiapine olanzapine ziprasidone and aripiprazole for at least 1 year and Group C n 22 newly diagnosed schizophrenic patients andor patients who did not receive any psychiatric treatment for at least 1 year
4 Outcome measurements The primary outcome was the assessment of periodontal condition in all study groups measured in terms of pocket depth PD tooth mobility clinical attachment loss CAL gingival recession and bleeding on probing BOP while the secondary outcomes were evaluation of BMD and the serum prolactin level measured by automated immunoassay in ngml
6Assessment of clinical data and patient condition Assessment of mental health The Positive and Negative Syndrome Scale PNSS 37 was used to evaluate each patients clinical history and current mental health state
Periodontal evaluation
All teeth were evaluated and recorded The means for the following parameters were computed pocket depth PD clinical attachment loss CAL and bleeding on probing BOP 38 39 Using a manual periodontal probe Williams periodontal probe PCP-12 Hu-Friedy Chicago IL USA PD and CAL measurements were collected on six surfaces per tooth mesio-buccal mid-buccal disto-buccal and mesio-lingual mid-lingual disto-lingual or palatal surfaceWhile CAL measures the distance between the cement-enamel junction of the tooth and the deepest aspect of the pocket probing pocket depth measures the distance between the gingival margin and the deepest part of the pocket Total mean PD of the six locations for each tooth was computed for each patient and distance was recorded to the nearest millimeter 40 Sulcus depths between 0 and 2 mm were regarded as normal 41 Gingival recession was measured from the CEJ to the marginal border of the soft tissue on the buccal and lingual sides of each tooth The total mean number of recessions per tooth for each patient was used to record tooth recessions Gingival recession if present was only used to calculate CAL by its addition to PD
Four surfaces per tooth were examined for BOP readings mesial distal buccal and lingual or palatal surface Bleeding on probing was examined directly after the PD measurement and was reported as absent 0 or present 1 30 seconds after applying the periodontal probe The proportion of teeth displaying BOP was recorded
Generalized mild periodontitis is defined as 30 of remaining teeth with PD 5 mm and 7 mm as per the 2015 Update to the 1999 Classification of Periodontitis Severe periodontitis was defined as a probing depth PD of 7 mm with localised periodontitis involving 30 of remaining teeth and generalised periodontitis involving 30 of remaining teeth 42
Assessment of bone mineral density
Dual-energy X-ray absorptiometry DEXA scan is an advanced technology that could detect bone mineral density The GE Lunar Prodigy densitometer was used to perform this testTo determine what constitutes healthy bone we utilized the World Health Organizations criteria a T score of -1 indicates normal bone a T score between -1 and -25 indicates osteopaenia and a T score of -25 indicates osteoporosis
Measurement of serum prolactin level
Blood will be withdrawn from all patients to determine the fasting serum prolactin level Prolactin concentrations in blood will be measured in a faculty laboratory by automated immunoassay methodology 43
7 Data collection and management Periodontal assessment will be carried out by the primary investigator SR who will be unaware of the patients psychological status and records to avoid potential bias The third investigator MC will collect all patient records to perform the final analysis
STATISTICAL METHODS
Quantitative continuous variables were expressed as mean SD As the quantitative variables were not normally distributed the Kruskal-Wallis test a non-parametric test was used to compare them among the 3 study groups A post hoc analysis was done for variables that showed a statistically significant difference in the Kruskal-Wallis test using Dwass-Steel-Critchlow-Fligner pairwise comparisons As for qualitative variables categorical the chi-square test was used to compare them among the 3 study groups and values were expressed as percentages Also linear regression analysis was performed to study the relation between 2 quantitative variables serum prolactin level and PD measurements while ordinal logistic regression was used to relate one quantitative serum prolactin level and one qualitative BMD or grades of periodontitis variables
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None