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

NCT03713567 | Completed DMC

• 1 other identifier: U1111-1217-5513
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Mucositis

Keywords

Aggressive Periodontitis; Biomarkers; Microbiota; Dental Implants

Outcome Measures

Primary Outcomes (1)

• 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; 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.

  Baseline, 7 days, 14 days, 21 days, 42 days

Secondary Outcomes (2)

• Changes of Angulated Bleeding Index in five different periods

  Baseline, 7 days, 14 days, 21 days, 42 days

• Changes of Plaque Index in five different periods

  Baseline, 7 days, 14 days, 21 days, 42 days

Other Outcomes (1)

• Changes of Gingival fluid in five different periods

  Baseline, 7 days, 14 days, 21 days, 42 days

Study Arms (2)

Experimentally induced plaque

PLACEBO COMPARATOR

Induced inflammation by suspension of oral hygiene

Behavioral: Experimentally induced plaque

Experimentally induced plaque GAP

EXPERIMENTAL

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

Behavioral: Experimentally induced plaque

Interventions

Experimentally induced plaque BEHAVIORAL

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

Experimentally induced plaque; Experimentally induced plaque GAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

Location

Related Publications (1)

• Dutra TP, Freitas Monteiro M, Franca-Grohmann IL, Casarin RCV, Casati MZ, Silverio Ruiz KG, Kumar PS, Sallum EA. Clinical, immunological and microbiological evaluation of experimental peri-implant mucositis and gingivitis in subjects with Grade C, stage III/IV periodontitis background. J Clin Periodontol. 2024 Feb;51(2):209-221. doi: 10.1111/jcpe.13896. Epub 2023 Nov 8.

  PMID: 37941050 DERIVED

MeSH Terms

Conditions

Gingivitis; Mucositis; Aggressive Periodontitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Periodontitis

Study Officials

• Tamires P Dutra, G

  School of Odontology of Piracicaba - Unicamp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 19, 2018
• Study Start: November 7, 2017
• Primary Completion: March 20, 2018
• Study Completion: June 6, 2018
• Last Updated: October 19, 2018

Record last verified: 2018-10

Locations

BR (1)