Non-surgical Treatment of Peri-implant Mucositis

Not Applicable

Completed

• Conditions: Peri-implant Mucositis
• Interventions: Device: Air-powder; Drug: Chlorhexidine

• Registration Number: NCT03915665
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-30
• Study Start: 2019-04-15
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-16
• Primary Completion: 2021-11-25
• Study Completion: 2021-11-25
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comprehensive treatment	Air-powder	Supragingival biofilm removal with Erythritol air-powder Submucosal biofilm removal with Erythritol air-powder (30%-60% power)
Standard treatment	Chlorhexidine	Manual treatment One application of Chlorhexidine 1% gel

Primary Outcome Measures

Name	Time	Method
Bleeding index change	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Limitations in daily activity	7 days	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.
PPD changes	2 weeks, 1 month, 3, 6, 12, 24 months	Changes in peri-implant probing depth between baseline and follow-up visit
Tissue level changes	2 weeks, 1 month, 3, 6, 12, 24 months	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
Marginal bone level changes	6 and 12 months	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.
Pain perception: Visual Analogue Scale	Immediately after intervention	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.
Taste sensation	7 days	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.
PI changes	2 weeks, 1 month, 3, 6, 12, 24 months	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.)
BI changes	2 weeks, 1 month, 6, 12, 24 months	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.
Taste alteration	7 days	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.

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Galeazzi; 🇮🇹 Milan, Italy