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The effect of Stannous Fluoride Toothpaste in the treatment of Experimental Peri-implant Mucositis and Gingivitis: a randomized, double-blind, parallel-arm clinical trial

The adjunctive Effect of Stannous Fluoride Toothpaste in the treatment of Experimental Peri-implant Mucositis and Gingivitis: a randomized, double-blind, parallel-arm clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-4hq4kd8
Enrollment
Unknown
Registered
2024-08-13
Start date
2024-05-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-Implantitis

Interventions

This randomized controlled clinical study has two parallel arms, two treatments, double-blind (participant and evaluator), and a single center. 50 people who meet the eligibility criteria will be assi

Sponsors

Faculdade de Odontologia da Universidade de São Paulo (FOUSP)
Lead Sponsor
Faculdade de Odontologia da Universidade de São Paulo (FOUSP)
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Volunteers with a minimum age of 18 years; with implant-supported single-unit screw-retained crown in the molar or premolar region with more than one year in function; with one molar or premolar tooth in the same arch as the implant; with a minimum of 20 teeth in function; periodontally healthy; with absence of infection, radiographic bone loss, and probing depth less than 4 mm at periodontal sites or less than or equal to 5 mm at peri-implant sites; with presence of at least 2 mm of peri-implant keratinized tissue; with full-mouth bleeding scores and full-mouth plaque scores less than or equal to 20%

Exclusion criteria

Exclusion criteria: Volunteers using antibiotics in the last 3 months; with implant insertion depth more than or equal to 3 mm; with diseases or systemic conditions that require the use of systemic anti-inflammatory drugs, antibiotics, anticoagulants, and others; smokers; diabetics; with an allergy to toothpaste or mouthwashes; pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frame
To evaluate the inflammation of the peri-implant mucosa, using the method of peri-implant probing, presenting the parameter as a percentage of sites with bleeding on probing.

Secondary

MeasureTime frame
To assess the inflammation of the peri-implant mucosa, using the method of passing the periodontal probe around the peri-implant margin, presenting the parameter according to the modified gingival index around implants with scores from 0 to 3.;To assess the recession of the peri-implant mucosa, using the periodontal probe around the implant and measuring the distance from the implant collar to the margin of the mucosa, presenting the parameter in numbers and millimeters.;To assess the clinical attachement level, using the periodontal probe around the implant and measuring the distance from the implant collar to the bottom of the peri-implant sulcus, presenting the parameter in numbers and millimeters.;To assess the accumulation of bacterial plaque around the implant, using the modified plaque index, presenting the parameter with scores from 0 to 3.;To assess the peri-implant probing depth, using the periodontal probe and calculating the distance from the margin of the peri-implant mucosa to the bottom of the peri-implant sulcus, presenting the parameter in numbers and millimeters.;To assess the gingival inflammation, using the method of passing the periodontal probe around the gingival margin, presenting the parameter according to the gingival index around teeth with scores from 0 to 3.;To assess gingival inflammation, using the periodontal probing method, presenting the parameter as a percentage of sites with bleeding on probing around teeth.;To assess the accumulation of bacterial plaque around teeth, using the plaque index, presenting the parameter with scores from 0 to 3.;To assess the periodontal probing depth, using the periodontal probe and measuring the distance from the gingival margin to the bottom of the gingival sulcus, presenting the parameter in numbers and millimeters.;To assess the gingival recession around teeth, using the periodontal probe and measuring the distance from the cemento-enamel junction to the gingival margin, presenting the parameter i

Countries

Brazil

Contacts

Public ContactMarinella Holzhausen

Faculdade de Odontologia da Universidade de São Paulo (FOUSP)

marinella@usp.br+55(11)30917833

Outcome results

None listed

Source: REBEC (via WHO ICTRP)