Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus ,Type 2, periodontitis, Gingival Crevicular Fluid, Prolactin, Non- surgical periodontal treatment
Brief summary
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
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.
Interventions
PROCEDURENon Surgical Periodontal Treatment
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.
DEVICEpaper points
we use paper point to collect GCF sample
DEVICEELISA Kits
The samples are analyzed by ELISA kits to measure prolactin levels
Sponsors
Faculty of Dental Medicine for Girls
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Prolactin Hormone Levels in Gingival Crevicular Fluid | Baseline and 3 months after non-surgical periodontal treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plaque Index (PI) | 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) |
| Change in Gingival Index (GI) | Baseline and 3 months after treatment | 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). |
| Change in Probing Depth (PD) | Baseline and 3 months after treatment | 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) |
| Change in Clinical Attachment Level (CAL) | Baseline and 3 months after treatment | 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) |
Countries
Egypt
Outcome results
None listed