NCT06038812

Brief Summary

This study aimed at exploring the effect of nonsurgical periodontal treatment on galectin 1 and 3 GCF levels in patients having gingivitis, periodontitis stage III compared to periodontally healthy individuals and if galectin-1 and -3 could serve as diagnostic markers and/or therapeutic targets for periodontitis, in addition to revealing their possible role in the periodontal disease. 45 systemically healthy participants were enrolled in this investigation, equally subdivided into three groups of 15 patients each: gingivitis, periodontitis (stage III) and control group with healthy gingiva. Probing depth, clinical attachment level, gingival and plaque index were registered. GCF levels of galectin-1 and -3 were evaluated in all included groups (before and after non-surgical treatment for periodontitis group) using enzyme linked immune-sorbent assay (ELISA) kit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

August 30, 2023

Last Update Submit

January 11, 2024

Conditions

GingivitisPeriodontitis

Outcome Measures

Primary Outcomes (1)

  • assessment of gal-1 and gal-3 in GCF samples

    samples are to be sent to biochemistry lab to measure galectin levels

    an average of about 10 months to assess level of gal-1 & -3 after collection of GCF samples at baseline (1st appointment) for all groups and another sample collection after 4 weeks for group II after performing scaling and root planning

Study Arms (3)

Group I

OTHER

patients diagnosed with gingivitis

Diagnostic Test: GCF sample collection

Group II

OTHER

patients diagnosed with periodontitis

Diagnostic Test: GCF sample collectionProcedure: non-surgical periodontal treatment

Group III

OTHER

healthy control

Diagnostic Test: GCF sample collection

Interventions

GCF sample collectionDIAGNOSTIC_TEST

collecting GCF from deepest sites by paper points

Group IGroup IIGroup III
non-surgical periodontal treatmentPROCEDURE

performing scaling and root planning using ultrasonic device and manual curettes

Group II

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-smokers from both genders.
  • Not suffering from systemic diseases, pregnancy/lactation.
  • Patients with only gingivitis or periodontitis stage III.
  • Periodontitis patients who did not receive any professional periodontal treatment in the last 6 months.

You may not qualify if:

  • smokers.
  • having systemic diseases, pregnancy/lactation.
  • taking contraceptive pills, antibiotics, anti-inflammatory, or immunosuppressive drugs in the past 6 months.
  • Patients having periodontitis any other stage than stage III.
  • Periodontitis patients who receive any professional periodontal treatment in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry, Fayoum university

Al Fayyum, Egypt

Location

Related Publications (1)

  • Tarrad NAF, Shaker OG, Elbanna RMH, AbdelKawy M. "Outcome of non-surgical periodontal treatment on Gal-1 and Gal-3 GCF levels in periodontitis patients: a case-control study". Clin Oral Investig. 2024 May 14;28(6):309. doi: 10.1007/s00784-024-05688-1.

    PMID: 38743248DERIVED

MeSH Terms

Conditions

GingivitisPeriodontitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 15, 2023

Study Start

August 1, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)