An interventional study of Non Surgical Periodontal Treatment and paper points in Type 2 Diabetes Mellitus, sponsored by Faculty of Dental Medicine for Girls. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-23.
Sponsored by Faculty of Dental Medicine for Girls · Not applicable, Interventional, and Treatment
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 80 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
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Exclusion Criteria:
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.
Device: paper points · Device: ELISA Kits
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.
Procedure: Non Surgical Periodontal Treatment · Device: paper points · Device: ELISA Kits
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
Procedure: Non Surgical Periodontal Treatment · Device: paper points · Device: ELISA Kits
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
Procedure: Non Surgical Periodontal Treatment · Device: paper points · Device: ELISA Kits
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.
we use paper point to collect GCF sample
The samples are analyzed by ELISA kits to measure prolactin levels
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
Time frame: Baseline and 3 months after non-surgical periodontal treatment
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)
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: Baseline and 3 months after treatment
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Faculty of Dental Medicine for Girls