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

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ClinicalTrials.gov Identifier: NCT03726411
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Eman Mohamed Amr, Cairo University

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.

Condition or disease Intervention/treatment Phase
Periodontitis Prolactin in GCF Procedure: non-surgical periodontal therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Non-surgical Periodontal Therapy on the Gingival Crevicular Fluid Levels of Prolactin Hormone in Patients With Periodontitis.
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Prolactin

Arm Intervention/treatment
Experimental: periodontitis group
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
scaling and root planing

No Intervention: control group
in this group of systemically and periodontally healthy participants, prolactin in GCF will be assessed at baseline only



Primary Outcome Measures :
  1. prolactin in GCF [ Time Frame: 3 months ]
    prolactin level in GCF by ELISA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726411


Locations
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Egypt
Faculty of Dentistry
Cairo, Egypt, 11431
Sponsors and Collaborators
Eman Mohamed Amr

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Responsible Party: Eman Mohamed Amr, Associate Professor of Oral Medicine and Periodontology, Cairo University
ClinicalTrials.gov Identifier: NCT03726411     History of Changes
Other Study ID Numbers: Prolactin 101
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eman Mohamed Amr, Cairo University:
periodontitis
Prolactin
GCF
non-surgical periodontal treatment
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs