Prolactin Levels in Type 2 Diabetic Patients With Stage III Periodontitis (prolactin)

Faculty of Dental Medicine for Girls

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Procedure: Non Surgical Periodontal Treatment; Device: paper points; Device: ELISA Kits

Study type: Interventional

Funder types: Other

Identifiers

NCT06941246

P-ME-24-04

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Healthy (control).

Other group

Description:

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).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.

Treatment:

Device: ELISA Kits

Device: paper points

Stage III periodontitis without diabetes

Active Comparator group

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.

Treatment:

Device: ELISA Kits

Device: paper points

Procedure: Non Surgical Periodontal Treatment

Stage III periodontitis with controlled type 2 diabetes

Active Comparator group

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: Samples will be collected from the buccal aspects of two interproximal sites in teeth that had the highest signs of inflammation and attachment loss

Treatment:

Device: ELISA Kits

Device: paper points

Procedure: Non Surgical Periodontal Treatment

Stage III periodontitis with uncontrolled type 2 diabetes

Active Comparator group

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: Samples will be collected from the buccal aspects of two interproximal sites in teeth that had the highest signs of inflammation and attachment loss

Treatment:

Device: ELISA Kits

Device: paper points

Procedure: Non Surgical Periodontal Treatment