Mucositis, Peri Implant Mucositis
Conditions
Keywords
Enamel matrix derivative
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 use of enamel matrix protein derivative (EMD). Specifically, the primary outcome of the present study compared the efficacy of NSPI +EMD with respect to NSPI and placebo in the treatment of PM at 6 months follow-up by means of BOP reduction. The secondary outcome evaluated the influence of possible predictors on the BOP changes among all follow-up sessions.
Detailed description
Patients (n° 54) with Implants affected by PM were randomly assigned to test (NSMD+EMD) 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) will assessed as well as levels of periodontal bacteria such as Aggregatibacter Actynomycencomitans, Porphyromonas Gingivalis, Tannerella Forsythia and Treponema Denticola. 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.
Interventions
OTHERPlacebo gel
Patients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of a placebo gel
Patients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of non-surgical treatment plus Enamel Matrix Proteins Derivative
Sponsors
University of Catania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sealed envelopes
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on probing (BOP) changes | 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
| Measure | Time frame | Description |
|---|---|---|
| Full mouth plaque score (FMPS) % changes | 6-months | Full mouth plaque score (FMPS) % changes |
| Full mouth bleeding score (FMBS) % changes | 6-months | Changes in FMBS |
| Probing pocket depth (PPD) changes | 6-months | Changes in PPD |
| Plaque at implant sites according to modified plaque index (mPlI) changes score | 6-months | Changes in mPlI 0-4 score |
| Patient-Reported Outcome Measures (PROMs) | 6-months | Patient-Reported Outcome Measures (PROMs) Were evaluated PROMs such as the number of abscesses, systemic complications, gingival recession, excessive bleeding, allergic effects, systemic impacts and related drug side effects |
| Plaque at implant sites according to modified gingival index (mGI) changes score | 6-months | Changes in mGI 0-4 score |
Countries
Italy
Outcome results
None listed