The Effect of Time on the Outcome of Periodontal Treatment.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Time on the Outcome of Periodontal Treatment.

Conditions
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Periodontitis

Intervention / Treatment
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* Procedure: Periodontal treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Periodontitis patients<br>Periodontitis patients receiving non-surgical periodontal treatment. | Procedure: Periodontal treatment<br>* Non-surgical periodontal treatment<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, Re-evaluation, Non-surgical periodontal treatment