The Effect of Time on the Outcome of Periodontal Treatment.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Periodontal treatment

Detailed Description

This randomized clinical trial aims to clarify which is the best time to re-evaluate the therapeutic result after non-surgical periodontal treatment. For this purpose the participants will be recruited among people who come to the Periodontal Department of 251 Hellenic Air Force Hospital for periodontal treatment. Each participant is going to submit informed consent in order to be included in the study. Patients with the diagnosis of Periodontitis will be submitted to non-surgical periodontal treatment with ultrasonic and manual scalers within two sessions, under local anaesthesia. The result of the treatment is going to be evaluated at 6, 12 and 24 weeks after treatment completion.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georgia Malamoudi, DDS,MSc; Phone Number: 0030 6983394983; Email: georgia.malamoudi@gmail.com
• Study Contact Backup: Name: George Koukos, DDS,PhD; Phone Number: 0030 6983520282; Email: gkoukos1977@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Periodontitis patients; Periodontitis patients receiving non-surgical periodontal treatment.	Procedure: Periodontal treatment; Non-surgical periodontal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level	The distance between cementoenamel junction and the base of the sulcus/pocket	Baseline, 6, 12, 24 weeks after treatment
Plaque Index	Number of sites with presence of dental plaque/ total number of sites	Baseline, 6, 12, 24 weeks after treatment
Bleeding on Probing	Number of sites with presence of bleeding/total number of sites	Baseline, 6, 12, 24 weeks after treatment
Tooth Mobility	degree of tooth mobility	Baseline, 6, 12, 24 weeks after treatment
Furcation involvement	Presence or absence of furcation involvement and degree of furcation defect	Baseline, 6, 12, 24 weeks after treatment
matrix metalloproteinase	matrix metalloproteinase 8 levels in whole saliva	Baseline, 6, 12, 24 weeks after treatment
Oral Health Impact Profile (OHIP)-14 Questionnaire	Questionnaire	Baseline, 6, 12, 24 weeks after treatment

Collaborators and Investigators

• Sponsor: 251 Hellenic Air Force & VA General Hospital
• Investigators: Study Director: George Koukos, DDS, PhD, 251 Hellenic Air Force & VA Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 3, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Periodontitis; Re-evaluation; Non-surgical periodontal treatment
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: 251Hellenic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No