Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis
- Conditions
- GingivitisMucositis
- Interventions
- Behavioral: Experimentally induced plaque
- Registration Number
- NCT03713567
- Lead Sponsor
- University of Campinas, Brazil
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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);
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimentally induced plaque Experimentally induced plaque Induced inflammation by suspension of oral hygiene Experimentally induced plaque GAP Experimentally induced plaque Induced inflammation by suspension of oral hygiene in patients with history of Generalized Aggressive periodontitis
- Primary Outcome Measures
Name Time Method Changes of Modified Gingival Index in five different periods Baseline, 7 days, 14 days, 21 days, 42 days According to the method of Löe \& Silness (1963) without the bleeding in the component of prueba.Measure at each visit 0 - absence of inflammation;
1. - Light inflammation - slight color change and little alteration in gingival texture;
2. - Moderate inflammation - moderate texture change, redness, edema, hypertrophy.
3. - Severe inflammation - redness, hypertrophy.
- Secondary Outcome Measures
Name Time Method Changes of Angulated Bleeding Index in five different periods Baseline, 7 days, 14 days, 21 days, 42 days 0 - No bleeding.
1. - Bleeding after probe stimulation.
2. - Spontaneous bleedingChanges of Plaque Index in five different periods Baseline, 7 days, 14 days, 21 days, 42 days 0 - Absence of plaque
1. - 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.
2. - Moderate accumulation in the periodontal pocket, dental surface or gingival margin, seen with the naked eye.
3. - Abundance of plaque in the periodontal pocket and / or on the dental surface and gingival margin.
Trial Locations
- Locations (1)
Piracicaba Dental School, State University of Campinas
🇧🇷Piracicaba, São Paulo, Brazil