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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
74
Chlorhexidine gel 1% one single application after mechanical biofilm removal through manual instruments
Erythritol powder using air-powder device
IRCCS Istituto Ortopedico Galeazzi
Milan, Italy
Bleeding index change
The primary outcome measure is the change in bleeding index between the baseline and the follow-up visit, on the basis of the following index: 0) no bleeding; 1) bleeding on probing without redness and swelling; 2) bleeding on probing, redness and swelling; and 3) spontaneous bleeding.
Time frame: 3 months
PPD changes
Changes in peri-implant probing depth between baseline and follow-up visit
Time frame: 2 weeks, 1 month, 3, 6, 12, 24 months
Tissue level changes
Changes in tissue level between baseline and follow-up visit, measured as the distance between a reference point on an occlusal personalized stent, made with polyvinylsiloxane impression material, and the mucosal margin
Time frame: 2 weeks, 1 month, 3, 6, 12, 24 months
PI changes
Changes in plaque index between baseline and follow-up visit on the basis of the following indeX: 0) no plaque accumulation; 1) plaque accumulation only detectable using a probe; 2) moderate accumulation of visible plaque/ calculus; 3) high accumulation of visible plaque/calculus.)
Time frame: 2 weeks, 1 month, 3, 6, 12, 24 months
BI changes
The primary outcome measure is the change in bleeding index between the baseline and the follow-up visit, on the basis of the following index: 0) no bleeding; 1) bleeding on probing without redness and swelling; 2) bleeding on probing, redness and swelling; and 3) spontaneous bleeding.
Time frame: 2 weeks, 1 month, 6, 12, 24 months
Marginal bone level changes
Changes in radiographic marginal bone level between baseline and follow-up visit measured comparing the periapical radiograph (with individualized holder) taken during baseline visit and the ones taken 6 and 12 months after intervention.
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Time frame: 6 and 12 months
Pain perception: Visual Analogue Scale
Pain perception during intervention, measured with a 10-mm long Visual Analogue Scale scale being 0 equal to no pain and 10 equal to maximum, unbearable, pain. Lower values represent better outcome.
Time frame: Immediately after intervention
Limitations in daily activity
Limitations in daily activity measured with a 10-mm long VAS scale being 0 equal to no limitation and 10 equal to complete limitation in daily activity, recorded daily. Lower values represent better outcome.
Time frame: 7 days
Taste alteration
Alteration in taste measured with a 10-mm long VAS scale being 0 equal to no alteration and 10 equal to complete taste alteration, recorded daily. Lower values represent better outcome.
Time frame: 7 days
Taste sensation
Taste sensation measured with a 10-mm long VAS scale being 0 equal to no sensation and 10 equal to revolting taste sensation, recorded daily. Lower values represent better outcome.
Time frame: 7 days