Non-surgical Treatment of Peri-implant Mucositis

NCT03915665 | Completed

• 1 other identifier: NSTPM
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• PPD changes

  2 weeks, 1 month, 3, 6, 12, 24 months

• Tissue level changes

  2 weeks, 1 month, 3, 6, 12, 24 months

• PI changes

  2 weeks, 1 month, 3, 6, 12, 24 months

• BI changes

  2 weeks, 1 month, 6, 12, 24 months

• Marginal bone level changes

  6 and 12 months

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

Manual treatment One application of Chlorhexidine 1% gel

Drug: Chlorhexidine

Comprehensive treatment

EXPERIMENTAL

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

Device: Air-powder

Interventions

Chlorhexidine DRUG

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

Standard treatment

Air-powder DEVICE

Erythritol powder using air-powder device

Comprehensive treatment

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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).

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

Location

MeSH Terms

Interventions

Chlorhexidine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2018
• First Posted: April 16, 2019
• Study Start: April 15, 2019
• Primary Completion: November 25, 2021
• Study Completion: November 25, 2021
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

IT (1)