Effect of Periodontal Treatment on the Biomechanical Properties of the Periodontium.

Study Overview
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Brief Summary
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Investigation of the biomechanical properties of the periodontal tissues in patients with periodontal disease. Non-surgical periodontal therapy will be assessed between baseline and 30 post-op by general clinical measurements (KT, PPD, CAL, BOP) as well as by biomechanical analysis and compared.

Detailed Description
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The study is designed as a prospective single center comparative clinical trial to investigate the biomechanical properties of the periodontal tissues in 30 patients with periodontal disease. Success of non-surgical periodontal therapy between baseline and 30 post-op will be assessed by general clinical measurements (KT, PD, CAL, BOP) as well as by biomechanical analysis. Besides assessment for regular treatment effectiveness, safety parameter such as wound healing and adverse events will be assessed. Additionally 10 periodontally healthy persons without local inflammation and bone loss shall be monitored and used a control group for reference to the test teeth.

Official Title
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The Effect of Non-surgical Periodontal Treatment on the Biomechanical Properties of the Periodontal Tissues, a Prospective Comparative Clinical Trial.

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Other: periodontal treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate/advanced/severe periodontitis Intact anterior dentition upper yaw. Expected performance of adequate oral hygiene Subjects must have voluntarily signed the informed consent form before any study related procedures Males and females with at least 18 years of age Subjects must be committed to the study and the required follow-up visits Subject must be judged in good general health as assessed by the investigator at time of non-surgical therapy Exclusion Criteria: Any contraindications for subgingival instrumentation Uncontrolled diabetes or other uncontrolled systemic diseases Disorders or treatments that compromise wound healing Medical conditions requiring chronic high dose steroid therapy Bone metabolic diseases Radiation or other immuno-oppressive therapy Chronic anti-inflammatory treatment (≥3 times per week) within 4 weeks prior to treatment Presence of oral lesions (such as ulceration, malignancy) Mucosal diseases (e.g., lichen planus, mouth ulcer) History of malignant disease in the oral cavity or previous radiotherapy to the head or neck Treatment with an investigational drug or device within the 30 day period immediately prior to therapy on study day 0 Female subjects who are nursing, pregnant, or plan to become pregnant Antibiotic treatment

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: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: prospective single center comparative clinical trial to investigate the biomechanical properties of periodontal tissues
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: periodontal treatment<br>non-surgical root debridement | Other: periodontal treatment<br>* non-surgical root debridement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth (PPD) at test tooth | mean PPD (mm) | 3 months | 
| Bleeding on Probing (BoP) | mean BoP (%) | 3 months | 
| Clinical attachment level (CAL) | mean attachment level (mm) | 3 months | 
| Biomechanical analysis | Tooth displacement (mm) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biotype/keratinized tissue width (KT) | mean - keratinized tissue width (KT) | 3 months | 
| 1.General Oral Health Assessments Indices (GOHAI) | Limit the kinds of food - Questionaire by visual analogue scale (VAS) | 3 months | 
| 2.General Oral Health Assessments Indices (GOHAI) | Trouble biting or chewing - Questionaire by visual analogue scale (VAS) | 3 months | 
| 3.General Oral Health Assessments Indices (GOHAI) | Problems to swallow comfortably - Questionaire by visual analogue scale (VAS) | 3 months | 
| 4.General Oral Health Assessments Indices (GOHAI) | Problems to speak clearly - Questionaire by visual analogue scale (VAS) | 3 months | 
| 5.General Oral Health Assessments Indices (GOHAI) | Discomfort when eating any kind of food - Questionaire by visual analogue scale (VAS) | 3 months | 
| 6.General Oral Health Assessments Indices (GOHAI) | Limit contact with people - Questionaire by visual analogue scale (VAS) | 3 months | 
| 7.General Oral Health Assessments Indices (GOHAI) | Pleased with look of teeth- Questionaire by visual analogue scale (VAS) | 3 months | 
| 8.General Oral Health Assessments Indices (GOHAI) | Used medication to relieve pain- Questionaire by visual analogue scale (VAS) | 3 months | 
| 9.General Oral Health Assessments Indices (GOHAI) | Worried about teeth, gums or dentures - Questionaire by visual analogue scale (VAS) | 3 months | 
| 10.General Oral Health Assessments Indices (GOHAI) | Self-conscious of teeth, gums or dentures - Questionaire by visual analogue scale (VAS) | 3 months | 
| 11.General Oral Health Assessments Indices (GOHAI) | Uncomfortable eating in front of others - Questionaire by visual analogue scale (VAS) | 3 months | 
| 12.General Oral Health Assessments Indices (GOHAI) | Sensitive to hot, cold or sweet foods - Questionaire by visual analogue scale (VAS) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomechanics, non-surgical periodontal treatment