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

Primary Purpose

Gingivitis, Mucositis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Experimentally induced plaque
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gingivitis focused on measuring Aggressive Periodontitis, Biomarkers, Microbiota, Dental Implants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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);

Sites / Locations

  • Piracicaba Dental School, State University of Campinas

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Experimentally induced plaque

Experimentally induced plaque GAP

Arm Description

Induced inflammation by suspension of oral hygiene

Induced inflammation by suspension of oral hygiene in patients with history of Generalized Aggressive periodontitis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes of Angulated Bleeding Index in five different periods
0 - No bleeding. - Bleeding after probe stimulation. - Spontaneous bleeding
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.

Full Information

First Posted
October 9, 2018
Last Updated
October 17, 2018
Sponsor
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT03713567
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
March 20, 2018 (Actual)
Study Completion Date
June 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Mucositis
Keywords
Aggressive Periodontitis, Biomarkers, Microbiota, Dental Implants

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimentally induced plaque
Arm Type
Placebo Comparator
Arm Description
Induced inflammation by suspension of oral hygiene
Arm Title
Experimentally induced plaque GAP
Arm Type
Experimental
Arm Description
Induced inflammation by suspension of oral hygiene in patients with history of Generalized Aggressive periodontitis
Intervention Type
Behavioral
Intervention Name(s)
Experimentally induced plaque
Intervention Description
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 Outcome Measure Information:
Title
Changes of Modified Gingival Index in five different periods
Description
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.
Time Frame
Baseline, 7 days, 14 days, 21 days, 42 days
Secondary Outcome Measure Information:
Title
Changes of Angulated Bleeding Index in five different periods
Description
0 - No bleeding. - Bleeding after probe stimulation. - Spontaneous bleeding
Time Frame
Baseline, 7 days, 14 days, 21 days, 42 days
Title
Changes of Plaque Index in five different periods
Description
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.
Time Frame
Baseline, 7 days, 14 days, 21 days, 42 days
Other Pre-specified Outcome Measures:
Title
Changes of Gingival fluid in five different periods
Description
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.
Time Frame
Baseline, 7 days, 14 days, 21 days, 42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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);
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamires P Dutra, G
Organizational Affiliation
School of Odontology of Piracicaba - Unicamp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piracicaba Dental School, State University of Campinas
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
13414-903
Country
Brazil

12. IPD Sharing Statement

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

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