Clinical trial NCT06941246: Prolactin Levels in Type 2 Diabetic Patients With Stage III Periodontitis
Official title: Gingival Crevicular Fluid Levels of Prolactin Hormone in Type 2 Diabetic Patients With Stage III Periodontitis Before and After Non-Surgical Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus ,Type 2
periodontitis
Gingival Crevicular Fluid
Prolactin
Non- surgical periodontal treatment
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2025-04-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Prolactin Hormone Levels in Gingival Crevicular Fluid
timeFrame: Baseline and 3 months after non-surgical periodontal treatment
Secondary outcomes:
measure: Change in Plaque Index (PI)
timeFrame: Baseline and 3 months after treatment
measure: Change in Gingival Index (GI)
timeFrame: Baseline and 3 months after treatment
measure: Change in Probing Depth (PD)
timeFrame: Baseline and 3 months after treatment
measure: Change in Clinical Attachment Level (CAL)
timeFrame: Baseline and 3 months after treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sara Ibrahim Hussein Eid
Study officials:
affiliation: Al-Azhar University
name: Naglaa El wakeel, Professer
role: STUDY_DIRECTOR
affiliation: Al-Azhar University
name: Zahraa Saeed, lecturer
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Olfat shaker, profeser
role: STUDY_DIRECTOR
References: