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NCT Number: NCT06941246

Prolactin Levels in Type 2 Diabetic Patients With Stage III Periodontitis

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sara Ibrahim Hussein Eid

Cairo, 12345, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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

Primary outcomes

  1. Change in Prolactin Hormone Levels in Gingival Crevicular Fluid

    Time frame: 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 outcomes

  1. Change in Plaque Index (PI)

    Time frame: 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)

  2. Change in Gingival Index (GI)

    Time frame: 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).

  3. Change in Probing Depth (PD)

    Time frame: 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)

  4. Change in Clinical Attachment Level (CAL)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Faculty of Dental Medicine for Girls

Other Gov

Registry information

Official study title

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

Acronym: prolactin

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 23, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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