Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis

Study Overview
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Brief Summary
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The objective of this study is to evaluate, through clinical, microbiological and immunological tests, the changes during the experimental gingivitis and mucositis model, between teeth and implants, and between patients with a history of aggressive periodontitis and healthy individuals.

Detailed Description
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The objective of this study is to evaluate, through clinical, microbiological and immunological tests, the changes during the experimental gingivitis and mucositis model, between teeth and implants, and between patients with a history of aggressive periodontitis and healthy individuals. 20 patients will be include, 10 healthy and 10 with a history of aggressive periodontitis. All patients must present the same type of implant and abutments, with prostheses in function for more than 6 months. They should also have a tooth located in the contralateral hemi-arch in a similar position, allowing a comparison with the implant. They will be submitted to the plaque-induced inflammation by suspension of oral hygiene only in the tested areas (tooth / implant), protected by a personalized stent made of plastic, according to the experimental gingivitis and mucositis model of 21 days of duration.

Official Title
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Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis in Patients With History of Agressive Periodontal Disease

Conditions
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Gingivitis, Mucositis

Intervention / Treatment
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* Behavioral: Experimentally induced plaque


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 18 years, History of aggressive periodontitis diagnosed according to the Armitage classification (1999) and verified by the dental chart and time of radiographic bone emission, being in periodontal maintenance for a little more than 6 months (Test group). Presence of teeth and implants (unitary prostheses) in the mouth; in a similar and counter-lateral position in the arch. The implants are the same system, including protective and dimensions. Probing Depth <5mm, in the interest sites. Plaque Index ≤ 20% (Silness & Löe, 1964), Healthy patients Signature of free and informed consent. Exclusion Criteria: Probing Depth> 5mm, in the interest sites. History of bone loss by peri-implantitis in the implant test. Smoking; Pregnancy; Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery); Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair);

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Experimentally induced plaque<br>Induced inflammation by suspension of oral hygiene | Behavioral: Experimentally induced plaque<br>* Experimentally induced plaque by suspension of oral hygiene only in the tested areas (tooth / implant), protected by a personalized stent made of plastic, according to the experimental gingivitis and mucositis model of 21 days of duration<br>|
| Experimental: Experimentally induced plaque GAP<br>Induced inflammation by suspension of oral hygiene in patients with history of Generalized Aggressive periodontitis | Behavioral: Experimentally induced plaque<br>* Experimentally induced plaque by suspension of oral hygiene only in the tested areas (tooth / implant), protected by a personalized stent made of plastic, according to the experimental gingivitis and mucositis model of 21 days of duration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Modified Gingival Index in five different periods | According to the method of Löe & Silness (1963) without the bleeding in the component of prueba.Measure at each visit 0 - absence of inflammation; - Light inflammation - slight color change and little alteration in gingival texture; - Moderate inflammation - moderate texture change, redness, edema, hypertrophy. - Severe inflammation - redness, hypertrophy. | Baseline, 7 days, 14 days, 21 days, 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Angulated Bleeding Index in five different periods | 0 - No bleeding. - Bleeding after probe stimulation. - Spontaneous bleeding | Baseline, 7 days, 14 days, 21 days, 42 days | 
| Changes of Plaque Index in five different periods | 0 - Absence of plaque - A thin layer of plaque adhered to the free gingival margin and adjacent to the dental surface. The plaque can be seen in situ only after the use of an evidentiary solution or through the passage of the periodontal probe through the dental surface. - Moderate accumulation in the periodontal pocket, dental surface or gingival margin, seen with the naked eye. - Abundance of plaque in the periodontal pocket and / or on the dental surface and gingival margin. | Baseline, 7 days, 14 days, 21 days, 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers, Microbiota, Aggressive Periodontitis, Dental Implants