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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)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07571850
Enrollment
26
Registered
2026-05-06
Start date
2024-10-01
Completion date
2025-06-30
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Periodontal Diseases

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.

Interventions

OTHERObese 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

OTHERobese patients with healthy periodontium with no intervention

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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in clinical attachment levelBaseline and 3 monthsClinical 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.
change in GCF levels of prolactin hormoneBaseline and 3 monthsGingival 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

MeasureTime frameDescription
change in Probing depthBaseline and 3 monthsmeasured 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).
change in gingival indexBaseline and 3 monthsGingival 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
change in plaque indexBaseline and 3 monthsPlaque 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026