Non-surgical Treatment of Peri-implant Mucositis

Study Overview
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Brief Summary
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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.

Official Title
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Non-surgical Treatment of Peri-implant Mucositis: A Randomized Controlled Clinical Trial Comparing Standard Treatment and Comprehensive Treatment

Conditions
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Peri-implant Mucositis

Intervention / Treatment
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* Drug: Chlorhexidine
* Device: Air-powder


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment<br>Manual treatment One application of Chlorhexidine 1% gel | Drug: Chlorhexidine<br>* Chlorhexidine gel 1% one single application after mechanical biofilm removal through manual instruments<br>|
| Experimental: Comprehensive treatment<br>Supragingival biofilm removal with Erythritol air-powder Submucosal biofilm removal with Erythritol air-powder (30%-60% power) | Device: Air-powder<br>* Erythritol powder using air-powder device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPD changes | Changes in peri-implant probing depth between baseline and follow-up visit | 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 | 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.) | 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. | 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. | 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. | 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. | 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. | 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. | 7 days |