Gingival Crevicular Fluid Levels of Prolactin Hormone in Obese Patients With Stage ii and Iii Periodontitis Before and After Non-surgical Periodontal Therapy

Gingival Crevicular Fluid Levels of Prolactin Hormone in Obese Patients With Stage ii and Iii Periodontitis Before and After Non-surgical Periodontal Therapy (a Comparative Clinical Study)

Obesity and periodontitis are among the most common chronic disorders affecting the world population, while Prolactin (PRL) is a neuroendocrine hormone that within the physiological range stimulates bone formation while mild to marked increase in its level induces bone resorption and inhibits bone formation.

Aim of the study: study aims to investigate prolactin (PRL) levels in gingival crevicular fluid (GCF) in obese (O) patients with and without stage II and III periodontitis (P). Further, to evaluate the effect of non-surgical periodontal therapy on these levels compared to controls.

Study Overview

• Status: Completed
• Conditions: Obesity; Periodontal Diseases
• Intervention / Treatment: Other: Obese patients with stage II and III periodontitis and non surgical peridontal therapy; Other: obese patients with healthy periodontium with no intervention

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Outpatient Clinic of Periodontology and Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Body mass index (more than 29.9 kg/m2).
• stage II and III periodontitis

Exclusion Criteria:

• Pregnancy or lactation.
• Any known systemic disease other than obesity
• Previous periodontal treatment (surgical or non-surgical) in last 6 months;
• Antibiotics in the past 3 months.
• Smoking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with peridontal disease	Other: Obese patients with stage II and III periodontitis and non surgical peridontal therapy; Patients had BMI of more than 29.9 kg/m2. charaterized by Stage II periodontitis with clinical attachment loss of 3-4 mm, radiographic bone loss confined to the coronal third, and no history of tooth loss due to infection and Stage III signifies severe destruction with attachment loss of more th toan or equal 5 mm, bone loss extending into the middle or apical third of the root, and potential tooth loss of up to four teeth. Patients will undergo full mouth scaling and root planning for two sessions
Active Comparator: Patients without peridontal disease	Other: obese patients with healthy periodontium with no intervention; Patients had BMI of more than 29.9 kg/m2 but with healthy peridontium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in clinical attachment level	Clinical attachment level (CAL) using a Williams probe (which manufactured in Europe from AISI 304 Stainless steel) from a fixed reference point on the crown to the base of the pocket.	Baseline and 3 months
change in GCF levels of prolactin hormone	Gingival crevicular fluid sample will be obtained from the buccal aspects of two interproximal sites in teeth that will have the highest signs of inflammation and attachment loss	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Probing depth	measured from the margin of the gingiva to the base of the pocket until slight resistance is encountered using a Williams probe (which manufactured in Europe from AISI 304 Stainless steel).	Baseline and 3 months
change in gingival index	Gingival Index evaluates the severity of gingivitis by scoring the color, consistency, and bleeding tendency of the soft tissues on a scale of 0 to 3, where a score of 2 indicates bleeding upon probing and a 3 signifies spontaneous bleeding	Baseline and 3 months
change in plaque index	Plaque Index focuses exclusively on the thickness of the microbial biofilm at the gingival margin, ranging from a score of 1, where plaque is only detectable by running a probe across the surface, to a score of 3, characterized by an abundance of visible soft matter.	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: April 18, 2026
• First Submitted That Met QC Criteria: May 3, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Periodontal Diseases
• Other Study ID Numbers: 0857-02/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No