NCT06366295

Brief Summary

The study aims to comparatively assess clinical parameters, biochemical and microbiological parameters after treatment of periodontitis using subgingival mechanotherapy traditional and subgingival mechanotherapy using a perioscope.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

April 17, 2024

Status Verified

June 1, 2023

Enrollment Period

10 months

First QC Date

April 10, 2024

Last Update Submit

April 15, 2024

Conditions

Periodontitis

Keywords

periodontal endoscopy, perioscopy

Outcome Measures

Primary Outcomes (4)

  • Probing pocket depth (PPD)

    Distance from the gingival margin to the bottom of the gingival sulcus

    0 (before), 3 and 6 months after SRP

  • Clinical attachment level (CAL)

    Distance from the cementoenamel junction to the bottom of the gingival sulcus

    0 (before), 3 and 6 months after SRP

  • Bleeding on probing (BoP)

    Percentage of sites with bleeding provoked by applying a probe to the bottom of a sulcus/pocket.

    0 (before), 3 and 6 months after SRP

  • Plaque index (PI)

    Percentage of sites with plaque

    0 (before), 3 and 6 months after SRP

Secondary Outcomes (2)

  • Width of keratinized tissue (KTW)

    0 (before), 3 and 6 months after SRP

  • Gingival thickness (GT)

    0 (before), 3 and 6 months after SRP

Other Outcomes (2)

  • Subgingival plaque pathogens (Aa, Pg, Td) levels

    0 (before) and 6 months after SRP

  • Gingival crevicular fluid levels of cytokines

    0 (before), 3 and 6 months after SRP

Study Arms (2)

Subgingival mechanotherapy with perioscopy

EXPERIMENTAL

Scaling and root planing using ultrasonic scaler and curettes, under the control of a perioscope, enabling real-time, magnified imaging of the root surface.

Device: subgingival mechanotherapy with perioscopy

Classical subgingival mechanotherapy

ACTIVE COMPARATOR

Scaling and root planing using ultrasonic scaler and curettes.

Device: classical subgingival mechanotherapy

Interventions

subgingival mechanotherapy with perioscopyDEVICE

Subgingival mechanotherapy using a machine scaler, curettes and a perioscope

Subgingival mechanotherapy with perioscopy
classical subgingival mechanotherapyDEVICE

Subgingival mechanotherapy using a machine scaler and curettes

Classical subgingival mechanotherapy

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 20-60; (II)
  • preserved lateral and anterior teeth;
  • no periodontal treatment in the last 12 months;
  • intermediate or advanced periodontitis (Stage II / III / IV)
  • in each quadrant at least three teeth with PPD\>5 mm after initial treatment (scaling, motivation, instruction)

You may not qualify if:

  • antibiotic therapy in the last 6 months;
  • smoking;
  • systemic diseases affecting periodontal tissues;
  • pregnancy or lactation;
  • orthodontic treatment;
  • tooth mobility II / III degree;
  • involvement of third degree furcations according to Hamp classification;
  • endodontic issues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Bartlomiej Górski, PhD

    Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolina Grzywacka

CONTACT

+48796137960k.grzywacka@gmail.com

Bartlomiej Górski, PhD

CONTACT

+48 22 116 64 31bartlomiej.gorski@wum.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2024

First Posted

April 15, 2024

Study Start

June 1, 2023

Primary Completion

April 1, 2024

Study Completion

November 1, 2024

Last Updated

April 17, 2024

Record last verified: 2023-06

Locations

PL(1)