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Completed

NCT Number: NCT03713567

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Experimentally induced plaque

Behavioral

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

Primary outcomes

  1. 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;

    • - Light inflammation - slight color change and little alteration in gingival texture;
    • - Moderate inflammation - moderate texture change, redness, edema, hypertrophy.
    • - Severe inflammation - redness, hypertrophy.

Secondary outcomes

  1. Changes of Angulated Bleeding Index in five different periods

    Time frame: Baseline, 7 days, 14 days, 21 days, 42 days

    0 - No bleeding.

    • - Bleeding after probe stimulation.
    • - Spontaneous bleeding
  2. Changes of Plaque Index in five different periods

    Time frame: Baseline, 7 days, 14 days, 21 days, 42 days

    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.

Other outcomes

  1. Changes of Gingival fluid in five different periods

    Time frame: Baseline, 7 days, 14 days, 21 days, 42 days

    Gingival fluid is collected from the fluid site and the paper strip is transfer to a Periotron 6000® (Pro Flow™, Amityville, NY, USA) for assessment of the fluid volume.

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 19, 2018
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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