Clinical trial NCT03713567: Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis
Official title: Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis in Patients With History of Agressive Periodontal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Mucositis
Keywords: Aggressive Periodontitis
Biomarkers
Microbiota
Dental Implants
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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);

Primary outcomes:
measure: Changes of Modified Gingival Index in five different periods
timeFrame: Baseline, 7 days, 14 days, 21 days, 42 days
Secondary outcomes:
measure: Changes of Angulated Bleeding Index in five different periods
timeFrame: Baseline, 7 days, 14 days, 21 days, 42 days
measure: Changes of Plaque Index in five different periods
timeFrame: Baseline, 7 days, 14 days, 21 days, 42 days
Other outcomes:
measure: Changes of Gingival fluid in five different periods
timeFrame: Baseline, 7 days, 14 days, 21 days, 42 days
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School, State University of Campinas
state: São Paulo
Study officials:
affiliation: School of Odontology of Piracicaba - Unicamp
name: Tamires P Dutra, G
role: PRINCIPAL_INVESTIGATOR
References: