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NCT05643287 Clinical Trial

The Effect of Time on the Outcome of Periodontal Treatment.

Periodontitis Clinical Trial

Official title:
The Effect of Time on the Outcome of Periodontal Treatment.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05643287
Other study ID # 251Hellenic
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2023
Est. completion date December 2023

Study information
Verified date July 2023
Source 251 Hellenic Air Force & VA General Hospital
Contact Georgia Malamoudi, DDS,MSc
Phone 6983394983
Email georgia.malamoudi@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 75
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Periodontal treatment
Non-surgical periodontal treatment

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
251 Hellenic Air Force & VA General Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Probing Pocket Depth 0 The distance between the gingival margin and the base of the sulcus/pocket Baseline
Primary Probing Pocket Depth 1 The distance between the gingival margin and the base of the sulcus/pocket 6 weeks after periodontal treatment
Primary Probing Pocket Depth 2 The distance between the gingival margin and the base of the sulcus/pocket 12 weeks after periodontal treatment
Primary Probing Pocket Depth 3 The distance between the gingival margin and the base of the sulcus/pocket 24 weeks after periodontal treatment
Secondary Clinical attachment level The distance between cementoenamel junction and the base of the sulcus/pocket Baseline, 6, 12, 24 weeks after treatment
Secondary Plaque Index Number of sites with presence of dental plaque/ total number of sites Baseline, 6, 12, 24 weeks after treatment
Secondary Bleeding on Probing Number of sites with presence of bleeding/total number of sites Baseline, 6, 12, 24 weeks after treatment
Secondary Tooth Mobility degree of tooth mobility Baseline, 6, 12, 24 weeks after treatment
Secondary Furcation involvement Presence or absence of furcation involvement and degree of furcation defect Baseline, 6, 12, 24 weeks after treatment
Secondary matrix metalloproteinase matrix metalloproteinase 8 levels in whole saliva Baseline, 6, 12, 24 weeks after treatment
Secondary Oral Health Impact Profile (OHIP)-14 Questionnaire Questionnaire Baseline, 6, 12, 24 weeks after treatment
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