NCT06941246

Prolactin Levels in Type 2 Diabetic Patients With Stage III Periodontitis

Gingival Crevicular Fluid Levels of Prolactin Hormone in Type 2 Diabetic Patients With Stage III Periodontitis Before and After Non-Surgical Treatments

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Faculty of Dental Medicine for Girls · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
PROCEDURE	Non 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.
DEVICE	paper points	we use paper point to collect GCF sample
DEVICE	ELISA Kits	The samples are analyzed by ELISA kits to measure prolactin levels

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-01-01
• Completion: 2025-04-01
• First posted: 2025-04-23
• Last updated: 2025-04-23

Locations

1 site across 1 country: Egypt