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

University of Campinas, Brazil

Status: Completed

Conditions: Mucositis; Gingivitis

Treatments: Behavioral: Experimentally induced plaque

Study type: Interventional

Funder types: Other

Identifiers

NCT03713567

U1111-1217-5513

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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);

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Experimentally induced plaque

Placebo Comparator group

Description:

Induced inflammation by suspension of oral hygiene

Treatment:

Behavioral: Experimentally induced plaque

Experimentally induced plaque GAP

Experimental group

Description:

Induced inflammation by suspension of oral hygiene in patients with history of Generalized Aggressive periodontitis

Treatment:

Behavioral: Experimentally induced plaque