The Effect of Non-surgical Periodontal Therapy on the Gingival Crevicular Fluid Levels of Prolactin Hormone in Patients With Periodontitis.

NCT ID: NCT03726411

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-02-01

Brief Summary

The present study will be conducted on fifty participants. All participants will receive a full-mouth clinical examination, and the following periodontal parameters will be recorded: Plaque Index (PI). Gingival Index (GI), probing depth (PD), and clinical attachment level (CAL). All of these measurements will be recorded at six sites at baseline for all participants and 3 months after non-surgical periodontal therapy for the study group. GCF samples will be collected from the buccal aspects of teeth that had the highest signs of inflammation and attachment loss for periodontitis group at baseline and 3 months after non-surgical periodontal therapy. As for controls, the samples will be collected from buccal aspect of upper first molar at baseline. The samples will be assayed for prolactin by using an enzyme linked immunosorbent assay kits (Elisa) according to the manufacturer instruction.

Conditions

Periodontitis; Prolactin in GCF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

periodontitis group

in this group, prolactin in GCF will be assessed at baseline and after 3 months of receiving non-surgical periodontal treatment

Group Type: EXPERIMENTAL

non-surgical periodontal therapy

Intervention Type: PROCEDURE

scaling and root planing

control group

in this group of systemically and periodontally healthy participants, prolactin in GCF will be assessed at baseline only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

non-surgical periodontal therapy

scaling and root planing

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subjects with moderate to severe chronic periodontitis, with probing pocket depth (PPD) ≥ 4-6 mm and clinical attachment level ≥ 4-5 mm, according to the American Academy of Periodontology.7
• Highly motivated and cooperative patients

Exclusion Criteria

• The presence of any systemic disease.
• Taking medications for the last 3 months before conducting this study.
• Pregnancy and lactation.
• Any type of previous periodontal treatment (surgical or non-surgical) in the preceding 6 months.
• Smoking (former or current).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eman Mohamed Amr

OTHER

Sponsor Role: lead

Responsible Party

Eman Mohamed Amr

Associate Professor of Oral Medicine and Periodontology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of Dentistry

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Prolactin 101

Identifier Type: -

Identifier Source: org_study_id