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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726411
• Other study ID #: Prolactin 101
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: March 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 1, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Periodontitis
• Prolactin in GCF

Intervention

Procedure:
• non-surgical periodontal therapy
scaling and root planing

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Eman Mohamed Amr

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prolactin in GCF	prolactin level in GCF by ELISA	3 months