Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
evaluate the role of prolactin hormone in the pathogenesis of periodontitis by assessing its local gingival levels and assess clinical parameters in patients who have type two 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. 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy (control). | Other | 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. |
|
| Stage III periodontitis without diabetes | Active Comparator | 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. |
|
| Stage III periodontitis with controlled type 2 diabetes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Surgical Periodontal Treatment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Prolactin Hormone Levels in Gingival Crevicular Fluid | 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 | Baseline and 3 months after non-surgical periodontal treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plaque Index (PI) | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Naglaa El wakeel, Professer | Al-Azhar University | Study Director |
| Zahraa Saeed, lecturer | Al-Azhar University | Study Director |
| Olfat shaker, profeser | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sara Ibrahim Hussein Eid | Cairo | 12345 | Egypt |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
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 |
|
| Stage III periodontitis with uncontrolled type 2 diabetes | Active Comparator | 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 |
|
|
| paper points | Device | we use paper point to collect GCF sample |
|
| ELISA Kits | Device | The samples are analyzed by ELISA kits to measure prolactin levels |
|
| Baseline and 3 months after treatment |
| Change in Gingival Index (GI) | 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). | Baseline and 3 months after treatment |
| Change in Probing Depth (PD) | 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) | Baseline and 3 months after treatment |
| Change in Clinical Attachment Level (CAL) | 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) | Baseline and 3 months after treatment |
| D004700 | Endocrine System Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |