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

U

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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