The Effect of Non-surgical Mechanical Debridement With or Without Full-mouth Disinfection in the Treatment of Peri-implant Mucositis. A Randomized Placebo-controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Catania
- Enrollment
- 56
- Locations
- 2
- Primary Endpoint
- Bleeding on probing (BOP) changes
Study Overview
Brief Summary
To evaluate the naturally occurring peri-implant mucositis (PM) treatment by means of non-surgical sub-marginal peri-implant instrumentation (NSPI) with or without full-mouth disinfection approach (FMD).
Detailed Description
Fifty-six patients with 85 Implants affected by PM were randomly assigned to test (NSMD+FMD) or control procedures (NSMD + placebo). At baseline, 1, 3, 6 months, full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depth (PD), bleeding on probing (BOP), modified gingival index (mGI), and modified plaque index (mPlI) were assessed. Furthermore, the proportions of Aggregatibacter Actynomycencomitans, Porphyromonas Gingivalis, Tannerella Forsythia and Treponema Denticola were also recorded. The BOP reduction was set as a primary outcome and the patient was considered statistical unit. Data were analysed to assess BOP reduction at a 6-month follow-up and to identify significant predictors of implant-site BOP through mixed generalized linear regression.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Sealed envelopes
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age ≥18 years old;
- •implants with smooth necks supporting cemented or screw-retained single-unit crowns with at least one BOP-positive site (Berglundh et al., 2018),
- •implants placed in both maxilla and mandible
- •patients with gingivitis or treated periodontitis with the absence of residual PD ≥5 mm
- •presence at least of 2 mm of keratinized mucosa (KT) at implant sites
Exclusion Criteria
- •presence of systemic diseases;
- •pregnancy or lactating;
- •use of inflammatory drugs or antibiotics within 3 months prior to study recruitment;
- •implants with modified (i.e., micro-rough) necks;
- •interproximal open contacts between implant restoration and adjacent teeth;
- •peri-implantitis (Berglundh et al., 2018)
Outcomes
Primary Outcomes
Bleeding on probing (BOP) changes
Time Frame: 6-months
The number of implants presenting with complete absence of BOP or implants with limited extent of BOP (≤1 spot/implant-the presence of a single spot)
Secondary Outcomes
- Full mouth plaque score (FMPS) % changes(6-months)
- Full mouth bleeding score (FMBS) % changes(6-months)
- Probing pocket depth (PPD) changes(6-months)
- Plaque at implant sites according to modified gingival index (mGI) changes score(6-months)
- Plaque at implant sites according to modified plaque index (mPlI) changes score(6-months)
Investigators
Gaetano Isola
Principal Investigator
University of Catania