NCT06784869

Brief Summary

Periodontitis is a chronic inflammatory disease resulting from bacterial invasion. Endothelin (ET-1) is a potent vasoconstrictor critical in the pathophysiology of periodontal diseases. Aim The present study aimed to measure the ET-1 concentrations in gingival crevicular fluid (GCF) at baseline, one and three months subsequently to non-surgical periodontal therapy. Material and methods Designed as a clinical trial, 24 periodontitis individuals will be voluntarily consented to participate. Following non-surgical periodontal treatment, GCF samples will be collected to determine the amount of endothelin-1 at baseline, one, and three months. Clinical periodontal parameters will be recorded.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 8, 2025

Last Update Submit

January 15, 2025

Conditions

Keywords

periodontitisendotheiln-1scaling and root surface debritment

Outcome Measures

Primary Outcomes (2)

  • PPD

    changes in PPD after non-surgical periodontal treatment.

    3 months recall visits

  • CAL

    changes in CAL after non-surgical periodontal treatment.

    3 months recall visits

Secondary Outcomes (1)

  • ET-1

    3 months recall visits

Study Arms (1)

have generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm).

EXPERIMENTAL

got generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm) will undergo scaling and root surface debritment

Device: Scaling and root surface debritment

Interventions

Patients with 4-6 mm pocket depth were participated in this study; clinical periodontal parameters (BOP, PLI, PPD, CAL) were recorded at the baseline visit. To ensure sampling accuracy, From the site two papers with GCF were sampled. Following sample collecting for GCF, Every patient received comprehensive mouth supragingival scaling with an ultrasonic scaler (WoodpEEKer® UDS-K) along with dental hygiene recommendations. One week later, the sites were irrigated with normal saline after being scaled and root planed (ScRp) with Gracey curette. Following completion of subgingival instrumentation, each patient returned to the clinic following 1 and 3 months for periodontal parameter recording and GCF collection. Throughout these sessions, every patient received reinstruction to engage in self-oral hygiene practices.

Also known as: Scaling and root planing
have generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm).

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • systemically healthy
  • Generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm)

You may not qualify if:

  • subjects who wore dental prosthesis
  • teeth with grade II mobility,
  • alcoholic and smoker, had treated caries
  • underwent periodontal therapy within the last four months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontitis

Interventions

Weights and MeasuresRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Investigative TechniquesDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Central Study Contacts

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
Head of periodontic department

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 20, 2025

Study Start

February 1, 2025

Primary Completion

July 30, 2025

Study Completion

September 30, 2025

Last Updated

January 20, 2025

Record last verified: 2025-01