Back to resultsThe Effect of Non-surgical Periodontal Therapy on the Gingival Crevicular Fluid Levels of Prolactin Hormone in Patients With Periodontitis.
Primary Purpose
Periodontitis, Prolactin in GCF
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
non-surgical periodontal therapy
Sponsored by
About this trial
This is an interventional other trial for Periodontitis focused on measuring periodontitis, Prolactin, GCF, non-surgical periodontal treatment
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).
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
periodontitis group
control group
Arm Description
in this group, prolactin in GCF will be assessed at baseline and after 3 months of receiving non-surgical periodontal treatment
in this group of systemically and periodontally healthy participants, prolactin in GCF will be assessed at baseline only
Outcomes
Primary Outcome Measures
prolactin in GCF
prolactin level in GCF by ELISA
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03726411
Brief Title
The Effect of Non-surgical Periodontal Therapy on the Gingival Crevicular Fluid Levels of Prolactin Hormone in Patients With Periodontitis.
Official Title
The Effect of Non-surgical Periodontal Therapy on the Gingival Crevicular Fluid Levels of Prolactin Hormone in Patients With Periodontitis.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eman Mohamed Amr
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Prolactin in GCF
Keywords
periodontitis, Prolactin, GCF, non-surgical periodontal treatment
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
periodontitis group
Arm Type
Experimental
Arm Description
in this group, prolactin in GCF will be assessed at baseline and after 3 months of receiving non-surgical periodontal treatment
Arm Title
control group
Arm Type
No Intervention
Arm Description
in this group of systemically and periodontally healthy participants, prolactin in GCF will be assessed at baseline only
Intervention Type
Procedure
Intervention Name(s)
non-surgical periodontal therapy
Intervention Description
scaling and root planing
Primary Outcome Measure Information:
Title
prolactin in GCF
Description
prolactin level in GCF by ELISA
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Facility Information:
Facility Name
Faculty of Dentistry
City
Cairo
ZIP/Postal Code
11431
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Non-surgical Periodontal Therapy on the Gingival Crevicular Fluid Levels of Prolactin Hormone in Patients With Periodontitis.
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