NCT06354504

Brief Summary

The aim of this study was to examine the relationship between healing response after non-surgical periodontal treatment and baseline gingival crevicular fluid (GCF) levels of bactericidal/permeability-increasing protein (BPI) and interleukin-1beta (IL-1ß).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

November 19, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2020

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

10 months

First QC Date

March 7, 2024

Last Update Submit

April 3, 2024

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Gingival crevicular fluid Bactericidal/permeability-increasing proteins levels

    Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis patients after Non-surgical periodontal treatment

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Gingival crevicular fluid interleukin-1Beta levels

    through study completion, an average of 1 year

Study Arms (1)

Healty

EXPERIMENTAL

Non-surgical periodontal treatment

Procedure: Non-surgical periodontal treatment

Interventions

Non-surgical periodontal treatmentPROCEDURE

Scaling and root planing in two sessions over the course of a 48-hour period comprised the standard treatment procedure

Healty

Eligibility Criteria

Age22 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy,
  • Stage II or III, Grade A periodontitis
  • Having at least 20 permanent teeth (excluding third molars and any tooth loss induced by -non-periodontal causes).

You may not qualify if:

  • Smoking,
  • use of alcohol; pregnancy or lactation; intake ofantibiotics, steroidal or non-steroidal anti-inflammatory drugs within the last 6 months
  • having received periodontal treatment within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akdeniz Üniversity

Antalya, 07070, Turkey (Türkiye)

Location

Akdeniz Üniversitesi Diş Hekimliği Fakültesi

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 7, 2024

First Posted

April 9, 2024

Study Start

November 19, 2019

Primary Completion

September 20, 2020

Study Completion

September 20, 2020

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)