Prolactin Levels in Type 2 Diabetic Patients With Stage III Periodontitis

NCT06941246 | Completed

• 1 other identifier: P-ME-24-04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus ,Type 2; periodontitis; Gingival Crevicular Fluid; Prolactin; Non- surgical periodontal treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in Plaque Index (PI)

  Baseline and 3 months after treatment

• Change in Gingival Index (GI)

  Baseline and 3 months after treatment

• Change in Probing Depth (PD)

  Baseline and 3 months after treatment

• Change in Clinical Attachment Level (CAL)

  Baseline and 3 months after treatment

Study Arms (4)

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.

Device: paper points; Device: 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.

Procedure: Non Surgical Periodontal Treatment; Device: paper points; Device: ELISA Kits

Stage III periodontitis with controlled 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

Procedure: Non Surgical Periodontal Treatment; Device: paper points; Device: ELISA Kits

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

Procedure: Non Surgical Periodontal Treatment; Device: paper points; Device: ELISA Kits

Interventions

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.

Stage III periodontitis with controlled type 2 diabetes; Stage III periodontitis with uncontrolled type 2 diabetes; Stage III periodontitis without diabetes

paper points DEVICE

we use paper point to collect GCF sample

Healthy (control).; Stage III periodontitis with controlled type 2 diabetes; Stage III periodontitis with uncontrolled type 2 diabetes; Stage III periodontitis without diabetes

ELISA Kits DEVICE

The samples are analyzed by ELISA kits to measure prolactin levels

Healthy (control).; Stage III periodontitis with controlled type 2 diabetes; Stage III periodontitis with uncontrolled type 2 diabetes; Stage III periodontitis without diabetes

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range from 18 to 60 years
• Stage III periodontitis
• Type 2 diabetes
• Only patients signing informed written consents

You may not qualify if:

• 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)

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Sara Ibrahim Hussein Eid

Cairo, 12345, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Periodontitis

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Naglaa El wakeel, Professer

  Al-Azhar University

  STUDY DIRECTOR

• Zahraa Saeed, lecturer

  Al-Azhar University

  STUDY DIRECTOR

• Olfat shaker, profeser

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master's degree student at oral medicine, peridontology ,oral diagnosis and oral Radiology Department, faculty of Dental Medicine for Girls ,Al Azhar university

Model Details: 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

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: April 23, 2025
• Study Start: October 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

EG (1)