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

NCT03726411 | Completed

• 1 other identifier: Prolactin 101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

periodontitis; Prolactin; GCF; non-surgical periodontal treatment

Outcome Measures

Primary Outcomes (1)

• prolactin in GCF

  prolactin level in GCF by ELISA

  3 months

Study Arms (2)

periodontitis group

EXPERIMENTAL

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

Procedure: non-surgical periodontal therapy

control group

NO INTERVENTION

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

Interventions

non-surgical periodontal therapy PROCEDURE

scaling and root planing

periodontitis group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eman Mohamed Amr: lead

Study Sites (1)

Faculty of Dentistry

Cairo, 11431, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Oral Medicine and Periodontology

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: October 31, 2018
• Study Start: November 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: February 1, 2019
• Last Updated: March 12, 2019

Record last verified: 2019-03

Locations

EG (1)