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NCT Number: NCT07571850

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

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.

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Key information

Conditions

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

Age range

25 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

obese patients with healthy periodontium with no intervention

Other

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

Primary outcomes

  1. change in clinical attachment level

    Time frame: Baseline and 3 months

    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.

  2. change in GCF levels of prolactin hormone

    Time frame: Baseline and 3 months

    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

Secondary outcomes

  1. change in Probing depth

    Time frame: Baseline and 3 months

    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).

  2. change in gingival index

    Time frame: Baseline and 3 months

    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

  3. change in plaque index

    Time frame: Baseline and 3 months

    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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 6, 2026
Registry last updated
May 6, 2026

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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