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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03713567
• Other study ID #: U1111-1217-5513
• Status: Completed
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: June 6, 2018

Study information

• Verified date: October 2018
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 6, 2018
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• Gingivitis
• Mucositis

Intervention

Behavioral:
• Experimentally 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

Locations

Country	Name	City	State
Brazil	Piracicaba Dental School, State University of Campinas	Piracicaba	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes of Gingival fluid in five different periods	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.	Baseline, 7 days, 14 days, 21 days, 42 days
Primary	Changes of Modified Gingival Index in five different periods	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.	Baseline, 7 days, 14 days, 21 days, 42 days
Secondary	Changes of Angulated Bleeding Index in five different periods	0 - No bleeding.; - Bleeding after probe stimulation.; - Spontaneous bleeding	Baseline, 7 days, 14 days, 21 days, 42 days
Secondary	Changes of Plaque Index in five different periods	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.	Baseline, 7 days, 14 days, 21 days, 42 days