ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 287501 for:    ALL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03713567
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Enilson Antonio Sallum, University of Campinas, Brazil

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.

Condition or disease Intervention/treatment Phase
Gingivitis Mucositis Behavioral: Experimentally induced plaque Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis in Patients With History of Agressive Periodontal Disease
Actual Study Start Date : November 7, 2017
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : June 6, 2018

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




Primary Outcome Measures :
  1. Changes of Modified Gingival Index in five different periods [ Time Frame: Baseline, 7 days, 14 days, 21 days, 42 days ]

    According 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 Outcome Measures :
  1. Changes of Angulated Bleeding Index in five different periods [ Time Frame: Baseline, 7 days, 14 days, 21 days, 42 days ]

    0 - No bleeding.

    1. - Bleeding after probe stimulation.
    2. - Spontaneous bleeding

  2. Changes of Plaque Index in five different periods [ Time Frame: Baseline, 7 days, 14 days, 21 days, 42 days ]

    0 - 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 Outcome Measures:
  1. Changes of Gingival fluid in five different periods [ Time Frame: Baseline, 7 days, 14 days, 21 days, 42 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713567


Locations
Brazil
Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, Brazil, 13414-903
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Principal Investigator: Tamires P Dutra, G FOP-UNICAMP

Responsible Party: Enilson Antonio Sallum, Full Professor, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT03713567     History of Changes
Other Study ID Numbers: U1111-1217-5513
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Enilson Antonio Sallum, University of Campinas, Brazil:
Aggressive Periodontitis
Biomarkers
Microbiota
Dental Implants

Additional relevant MeSH terms:
Mucositis
Gingivitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases
Periodontal Diseases