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OpenTrials
Completed

NCT Number: NCT03726411

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Prolactin in GCF Stomatognathic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Cairo, 11431, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Non-surgical periodontal therapy

Procedure

scaling and root planing

Primary outcomes

  1. prolactin in GCF

    Time frame: 3 months

    prolactin level in GCF by ELISA

Sponsors and collaborators

Lead sponsor

Eman Mohamed Amr

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2018
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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