Prolactin Levels in Type 2 Diabetic Patients With Stage III Periodontitis (prolactin)
Gingival Crevicular Fluid Levels of Prolactin Hormone in Type 2 Diabetic Patients With Stage III Periodontitis Before and After Non-Surgical Treatments
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Periodontal Examination At baseline, all participants received a full-mouth clinical examination, and the following periodontal parameters will be recorded: Plaque Index (PI) (19), Gingival Index (GI) (20), Pocket Depth (PD), and Clinical Attachment Loss (CAL).
Initial periodontal examination, full mouth scaling and root planning (SRP), clinical measurements before and after treatment, gingival crevicular fluid sampling as well as reinforcement of oral hygiene at baseline and during follow-up evaluations will be performed by the same periodontist (E.A.). Reinforcement of oral hygiene will be done every month for 3 months.
Gingival fluid sampling:
Gingival crevicular fluid (GCF) collection will be done the second day after clinical examination to prevent the contamination of sample with blood associated with the probing of inflamed sites. Samples will be collected from the buccal aspects of two interproximal sites in teeth that had the highest signs of inflammation and attachment loss for periodontitis groups, this will be done before, and 3 months after SRP. For the control group, samples will be collected from the upper first molar.
The samples will be assayed for PRL by using an enzyme linked immunosorbent assay (ELISA) kits.
Patient's examinations:
Glycosylated Hemoglobin (Hemoglobin A1c) test and Body Mass Index will be measured to all participants.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt, 12345
- Sara Ibrahim Hussein Eid
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age range from 18 to 60 years
- Stage III periodontitis
- Type 2 diabetes
- Only patients signing informed written consents
Exclusion Criteria:
- Pregnancy or lactation
- Any known systemic disease
- Any type of previous periodontal treatment (surgical or non-surgical) in the preceding 6 months
- Smoking (former or current)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Healthy (control).
a full-mouth clinical examination, and the following periodontal parameters will be recorded: Plaque Index (PI) (19), Gingival Index (GI) (20), Pocket Depth (PD), and Clinical Attachment Loss (CAL).Gingival fluid sampling: Gingival crevicular fluid (GCF) collection will be done the second day after clinical examination to prevent the contamination of sample with blood associated with the probing of inflamed sites. Samples will be collected from the buccal aspects of two interproximal sites in teeth that had the highest signs of inflammation and attachment loss for periodontitis groups, this will be done before, and 3 months after SRP. For the control group, samples will be collected from the upper first molar. The samples will be assayed for PRL by using an enzyme linked immunosorbent assay (ELISA) kits. |
we use paper point to collect GCF sample
The samples are analyzed by ELISA kits to measure prolactin levels
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Active Comparator: Stage III periodontitis without diabetes
Periodontal Examination At baseline, all participants received a full-mouth clinical examination, and the following periodontal parameters will be recorded: Plaque Index (PI) (19), Gingival Index (GI) (20), Pocket Depth (PD), and Clinical Attachment Loss (CAL). Initial periodontal examination, full mouth scaling and root planning (SRP), clinical measurements before and after treatment, gingival crevicular fluid sampling as well as reinforcement of oral hygiene at baseline and during follow-up evaluations will be performed by the same periodontist (E.A.). Reinforcement of oral hygiene will be done every month for 3 months. Gingival fluid sampling: Gingival crevicular fluid (GCF) collection will be done the second day after clinical examination to prevent the contamination of sample with blood associated with the probing of inflamed sites. |
we use paper point to collect GCF sample
The samples are analyzed by ELISA kits to measure prolactin levels
the intervention includes Non Surgical Periodontal Therapy( scaling and root planning ),performed to reduce periodontal inflammation .Gingival Crevicular fluid samples will be collected before and after treatment to assess changes in prolactin hormone levels.
|
|
Active Comparator: Stage III periodontitis with controlled type 2 diabetes
Periodontal Examination At baseline, all participants received a full-mouth clinical examination, and the following periodontal parameters will be recorded: Plaque Index (PI) (19), Gingival Index (GI) (20), Pocket Depth (PD), and Clinical Attachment Loss (CAL). Initial periodontal examination, full mouth scaling and root planning (SRP), clinical measurements before and after treatment, gingival crevicular fluid sampling as well as reinforcement of oral hygiene at baseline and during follow-up evaluations will be performed by the same periodontist (E.A.). Reinforcement of oral hygiene will be done every month for 3 months. Gingival fluid sampling: Samples will be collected from the buccal aspects of two interproximal sites in teeth that had the highest signs of inflammation and attachment loss |
we use paper point to collect GCF sample
The samples are analyzed by ELISA kits to measure prolactin levels
the intervention includes Non Surgical Periodontal Therapy( scaling and root planning ),performed to reduce periodontal inflammation .Gingival Crevicular fluid samples will be collected before and after treatment to assess changes in prolactin hormone levels.
|
|
Active Comparator: Stage III periodontitis with uncontrolled type 2 diabetes
Periodontal Examination At baseline, all participants received a full-mouth clinical examination, and the following periodontal parameters will be recorded: Plaque Index (PI) (19), Gingival Index (GI) (20), Pocket Depth (PD), and Clinical Attachment Loss (CAL). Initial periodontal examination, full mouth scaling and root planning (SRP), clinical measurements before and after treatment, gingival crevicular fluid sampling as well as reinforcement of oral hygiene at baseline and during follow-up evaluations will be performed by the same periodontist (E.A.). Reinforcement of oral hygiene will be done every month for 3 months. Gingival fluid sampling: Samples will be collected from the buccal aspects of two interproximal sites in teeth that had the highest signs of inflammation and attachment loss |
we use paper point to collect GCF sample
The samples are analyzed by ELISA kits to measure prolactin levels
the intervention includes Non Surgical Periodontal Therapy( scaling and root planning ),performed to reduce periodontal inflammation .Gingival Crevicular fluid samples will be collected before and after treatment to assess changes in prolactin hormone levels.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Prolactin Hormone Levels in Gingival Crevicular Fluid
Time Frame: Baseline and 3 months after non-surgical periodontal treatment
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Gingival crevicular fluid (GCF) will be collected to measure prolactin hormone levels using enzyme-linked immunosorbent assay (ELISA) kits.
Samples will be taken from the buccal aspects of two interproximal sites in each participant.
Baseline and post-treatment samples will be collected and analyzed.
Higher prolactin levels may be associated with more severe inflammation.
Unit of Measure :ng/mL
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Baseline and 3 months after non-surgical periodontal treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Plaque Index (PI)
Time Frame: Baseline and 3 months after treatment
|
The Plaque Index will be measured using the Silness and Löe Index.
Scores range from 0 (no plaque) to 3 (abundant plaque on tooth surface).
Higher scores indicate worse oral hygiene.reinforcement of oral hygiene at baseline and during follow-up evaluations will be performed by the same periodontist (E.A.).
Reinforcement of oral hygiene will be done every month for 3 months.
Higher scores indicate worse oral hygiene.
Unit of measure: PI Score (0-3)
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Baseline and 3 months after treatment
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Change in Gingival Index (GI)
Time Frame: Baseline and 3 months after treatment
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The Gingival Index will be evaluated using the Löe and Silness method.
Scores range from 0 (normal gingiva) to 3 (severe inflammation with spontaneous bleeding).
Higher scores indicate worse gingival condition.
Unit of measure: GI Score (0-3).
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Baseline and 3 months after treatment
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Change in Probing Depth (PD)
Time Frame: Baseline and 3 months after treatment
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Probing depth will be measured using a periodontal probe at selected sites.
Measurements are recorded in millimeters.
Greater probing depth indicates more advanced periodontal destruction.
Unit of measure: millimeters (mm)
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Baseline and 3 months after treatment
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Change in Clinical Attachment Level (CAL)
Time Frame: Baseline and 3 months after treatment
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Clinical attachment level will be assessed using a periodontal probe to determine the extent of periodontal support loss.
Higher values indicate greater tissue damage.
Higher values indicate worse periodontal condition Unit of measure: millimeters (mm)
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Baseline and 3 months after treatment
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Collaborators and Investigators
Investigators
- Study Director: Naglaa El wakeel, Professer, Azhar University
- Study Director: Zahraa Saeed, lecturer, Azhar University
- Study Director: Olfat shaker, profeser, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-ME-24-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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