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

NCT07571850 | Completed

• 1 other identifier: 0857-02/2024
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Periodontal Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• change in Probing depth

  Baseline and 3 months

• change in gingival index

  Baseline and 3 months

• change in plaque index

  Baseline and 3 months

Study Arms (2)

Patients with peridontal disease

EXPERIMENTAL

Other: Obese patients with stage II and III periodontitis and non surgical peridontal therapy

Patients without peridontal disease

ACTIVE COMPARATOR

Other: obese patients with healthy periodontium with no intervention

Interventions

Obese patients with stage II and III periodontitis and non surgical peridontal therapy OTHER

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

Patients with peridontal disease

obese patients with healthy periodontium with no intervention OTHER

Patients had BMI of more than 29.9 kg/m2 but with healthy peridontium

Patients without peridontal disease

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

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

Alexandria, Egypt

Location

MeSH Terms

Conditions

Obesity; Periodontal Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: May 6, 2026
• Study Start: October 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

EG (1)