Non-surgical Treatment of Peri-implant Mucositis

NCT ID: NCT03915665

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2021-11-25

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.

Conditions

Peri-implant Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard treatment

Manual treatment One application of Chlorhexidine 1% gel

Group Type: ACTIVE_COMPARATOR

Chlorhexidine

Intervention Type: DRUG

Chlorhexidine gel 1% one single application after mechanical biofilm removal through manual instruments

Comprehensive treatment

Supragingival biofilm removal with Erythritol air-powder Submucosal biofilm removal with Erythritol air-powder (30%-60% power)

Group Type: EXPERIMENTAL

Air-powder

Intervention Type: DEVICE

Erythritol powder using air-powder device

Interventions

Chlorhexidine

Chlorhexidine gel 1% one single application after mechanical biofilm removal through manual instruments

Intervention Type: DRUG

Air-powder

Erythritol powder using air-powder device

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Countries

Italy

Other Identifiers

NSTPM

Identifier Type: -

Identifier Source: org_study_id