Non-surgical Treatment of Peri-implant Mucositis

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

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 Overview

• Status: Completed
• Conditions: Peri-implant Mucositis
• Intervention / Treatment: Drug: Chlorhexidine; Device: Air-powder

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20161
    • IRCCS Istituto Ortopedico Galeazzi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): November 25, 2021
• Study Completion (Actual): November 25, 2021

Study Registration Dates

• First Submitted: December 30, 2018
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: NSTPM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators planned to share anonymized IPD after the end of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No