Clinical trial NCT03915665: Non-surgical Treatment of Peri-implant Mucositis
Official title: Non-surgical Treatment of Peri-implant Mucositis: A Randomized Controlled Clinical Trial Comparing Standard Treatment and Comprehensive Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 74
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This a Randomized Controlled Clinical Trial comparing two techniques for the nonsurgical treatment of peri-implant mucositis. The main objective of the present randomized controlled clinical trial is to determine whether the application of a novel treatment strategy for peri-implant mucositis could lead to significantly improved clinical parameters as compared to standard treatment. Half of the patients receives treatment with manual instruments and chlorhexidine gel 1%, half receives treatment with submucosal biofilm removal by erythritol powder.


Eligibility criteria: Inclusion Criteria:

* Subjects should have at least one implant (Renvert et al. 2009),
* with bleeding on probing using a 0.2N probing force or spontaneous bleeding with local swelling (code 1, 2 or 3 as described in Corbella et al. 2011) and with bone resorption of no more of 1 mm (preferably no bone loss visible on radiographs) as evaluated through the use of standardized radiographs, taken with the use of an individualized radiograph holder in comparison with findings from radiographs taken immediately following placement of the implant prosthesis (similar to Renvert et al. 2009 and Algraffee et al. 2011).
* females and males 35 to 65 years old; (IV) full mouth bleeding score % lower than 20%.

Exclusion Criteria:

* systemic diseases that could affect the immune response or that could condition the bacterial colonization
* use of anti-inflammatory prescription medications, or antibiotics within the preceding respectively 1 week and 3 months or during the study,
* full-mouth plaque score (FMPS) \>20%;
* full-mouth bleeding score (FMBS) \>20%,
* smokers of more than 5 cigarettes a day,
* Documented allergy or intolerance towards the components of the products used in the study,
* Presence of active infection with suppuration.
* Absence of periodontitis in the rest of the mouth
* Pregnancy (certified by auto-declaration)
* Patients suffering from upper respiratory tract infections, from chronic bronchitis
* endocarditis, breast feeding, contagious disease, immune deficiency (neutropenia, angranulocytosis, diabetes, hemophilia), patients under treatment (radiotherapy, chemotherapy, antibiotics).

Primary outcomes:
measure: Bleeding index change
timeFrame: 3 months
Secondary outcomes:
measure: PPD changes
timeFrame: 2 weeks, 1 month, 3, 6, 12, 24 months
measure: Tissue level changes
timeFrame: 2 weeks, 1 month, 3, 6, 12, 24 months
measure: PI changes
timeFrame: 2 weeks, 1 month, 3, 6, 12, 24 months
measure: BI changes
timeFrame: 2 weeks, 1 month, 6, 12, 24 months
measure: Marginal bone level changes
timeFrame: 6 and 12 months
measure: Pain perception: Visual Analogue Scale
timeFrame: Immediately after intervention
measure: Limitations in daily activity
timeFrame: 7 days
measure: Taste alteration
timeFrame: 7 days
measure: Taste sensation
timeFrame: 7 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
References: