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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Mucositis
• Intervention / Treatment: Behavioral: Experimentally induced plaque

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Piracicaba, São Paulo, Brazil, 13414-903
      • Piracicaba Dental School, State University of Campinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Experimentally induced plaque; Induced inflammation by suspension of oral hygiene	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
EXPERIMENTAL: Experimentally induced plaque GAP; Induced inflammation by suspension of oral hygiene in patients with history of Generalized Aggressive periodontitis	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil
• Investigators: Principal Investigator: Tamires P Dutra, G, School of Odontology of Piracicaba - Unicamp

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 7, 2017
• Primary Completion (ACTUAL): March 20, 2018
• Study Completion (ACTUAL): June 6, 2018

Study Registration Dates

• First Submitted: October 9, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (ACTUAL): October 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Microbiota; Biomarkers; Dental Implants; Aggressive Periodontitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Mucositis
• Other Study ID Numbers: U1111-1217-5513

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No