NCT05643287

Brief Summary

Re-evaluation after non-surgical periodontal treatment remains an integral part of comprehensive periodontal therapy. This re-evaluation determines if a patient is in need either of surgical periodontal therapy or a personalized program of supportive periodontal treatment. However important, this time point is yet to be determined.This interventional study aims to clarify which is the best time to re-evaluate the therapeutic result after non-surgical periodontal treatment.

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
75

participants targeted

Target at P50-P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
2.2 years until next milestone

Study Start

First participant enrolled

February 3, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

November 28, 2022

Last Update Submit

December 14, 2024

Conditions

Keywords

PeriodontitisRe-evaluationNon-surgical periodontal treatment

Outcome Measures

Primary Outcomes (4)

  • Probing Pocket Depth 0

    The distance between the gingival margin and the base of the sulcus/pocket

    Baseline

  • Probing Pocket Depth 1

    The distance between the gingival margin and the base of the sulcus/pocket

    6 weeks after periodontal treatment

  • Probing Pocket Depth 2

    The distance between the gingival margin and the base of the sulcus/pocket

    12 weeks after periodontal treatment

  • Probing Pocket Depth 3

    The distance between the gingival margin and the base of the sulcus/pocket

    24 weeks after periodontal treatment

Secondary Outcomes (7)

  • Clinical attachment level

    Baseline, 6, 12, 24 weeks after treatment

  • Plaque Index

    Baseline, 6, 12, 24 weeks after treatment

  • Bleeding on Probing

    Baseline, 6, 12, 24 weeks after treatment

  • Tooth Mobility

    Baseline, 6, 12, 24 weeks after treatment

  • Furcation involvement

    Baseline, 6, 12, 24 weeks after treatment

  • +2 more secondary outcomes

Study Arms (1)

Periodontitis patients

EXPERIMENTAL

Periodontitis patients receiving non-surgical periodontal treatment.

Procedure: Periodontal treatment

Interventions

Non-surgical periodontal treatment

Periodontitis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systematically healthy adults
  • Informed consent form completion
  • Periodontitis Diagnosis
  • Patients not having received periodontal treatment since 12 months before

You may not qualify if:

  • Medical History that interferes with wound healing
  • Antibiotic and anti-inflammatory drugs intake
  • Medication that induces gingival enlargement
  • Pregnancy/ Lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontitis

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Health SurveysHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDentistryPeriodonticsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Dentistry

Study Officials

  • George Koukos, DDS, PhD

    251 Hellenic Air Force & VA Hospital

    STUDY DIRECTOR

Central Study Contacts

Georgia Malamoudi, DDS,MSc

CONTACT

George Koukos, DDS,PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attendant at Periodontology Department of 251 Hellenic Air Force & VA Hospital

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 8, 2022

Study Start

February 3, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share