Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis in Patients With History of Agressive Periodontal Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Changes of Modified Gingival Index in five different periods
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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);
Arms & Interventions
Experimentally induced plaque
Induced inflammation by suspension of oral hygiene
Intervention: Experimentally induced plaque (Behavioral)
Experimentally induced plaque GAP
Induced inflammation by suspension of oral hygiene in patients with history of Generalized Aggressive periodontitis
Intervention: Experimentally induced plaque (Behavioral)
Outcomes
Primary Outcomes
Changes of Modified Gingival Index in five different periods
Time Frame: 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 Outcomes
- Changes of Angulated Bleeding Index in five different periods(Baseline, 7 days, 14 days, 21 days, 42 days)
- Changes of Plaque Index in five different periods(Baseline, 7 days, 14 days, 21 days, 42 days)
Investigators
Enilson Antonio Sallum
Full Professor
University of Campinas, Brazil