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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03713567
Enrollment
20
Registered
2018-10-19
Start date
2017-11-07
Completion date
2018-06-06
Last updated
2018-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis, Mucositis

Keywords

Aggressive Periodontitis, Biomarkers, Microbiota, Dental Implants

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.

Interventions

BEHAVIORALExperimentally induced plaque

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

Sponsors

University of Campinas, Brazil
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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. * 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);

Design outcomes

Primary

MeasureTime frameDescription
Changes of Modified Gingival Index in five different periodsBaseline, 7 days, 14 days, 21 days, 42 daysAccording 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

MeasureTime frameDescription
Changes of Angulated Bleeding Index in five different periodsBaseline, 7 days, 14 days, 21 days, 42 days0 - No bleeding. 1. \- Bleeding after probe stimulation. 2. \- Spontaneous bleeding
Changes of Plaque Index in five different periodsBaseline, 7 days, 14 days, 21 days, 42 days0 - Absence of plaque 1. \- 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. 2. \- Moderate accumulation in the periodontal pocket, dental surface or gingival margin, seen with the naked eye. 3. \- Abundance of plaque in the periodontal pocket and / or on the dental surface and gingival margin.

Other

MeasureTime frameDescription
Changes of Gingival fluid in five different periodsBaseline, 7 days, 14 days, 21 days, 42 daysGingival 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026