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Non-surgical Treatment of Peri-implant Mucositis

Primary Purpose

Peri-implant Mucositis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Chlorhexidine
Air-powder
Sponsored by
Istituto Ortopedico Galeazzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implant Mucositis

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • IRCCS Istituto Ortopedico Galeazzi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard treatment

Comprehensive treatment

Arm Description

Manual treatment One application of Chlorhexidine 1% gel

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

PPD changes
Changes in peri-implant probing depth between baseline and follow-up visit
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
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.)
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 30, 2018
Last Updated
May 16, 2022
Sponsor
Istituto Ortopedico Galeazzi
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1. Study Identification

Unique Protocol Identification Number
NCT03915665
Brief Title
Non-surgical Treatment of Peri-implant Mucositis
Official Title
Non-surgical Treatment of Peri-implant Mucositis: A Randomized Controlled Clinical Trial Comparing Standard Treatment and Comprehensive Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
November 25, 2021 (Actual)
Study Completion Date
November 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Manual treatment One application of Chlorhexidine 1% gel
Arm Title
Comprehensive treatment
Arm Type
Experimental
Arm Description
Supragingival biofilm removal with Erythritol air-powder Submucosal biofilm removal with Erythritol air-powder (30%-60% power)
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Intervention Description
Chlorhexidine gel 1% one single application after mechanical biofilm removal through manual instruments
Intervention Type
Device
Intervention Name(s)
Air-powder
Intervention Description
Erythritol powder using air-powder device
Primary Outcome Measure Information:
Title
Bleeding index change
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
PPD changes
Description
Changes in peri-implant probing depth between baseline and follow-up visit
Time Frame
2 weeks, 1 month, 3, 6, 12, 24 months
Title
Tissue level changes
Description
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
Time Frame
2 weeks, 1 month, 3, 6, 12, 24 months
Title
PI changes
Description
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.)
Time Frame
2 weeks, 1 month, 3, 6, 12, 24 months
Title
BI changes
Description
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.
Time Frame
2 weeks, 1 month, 6, 12, 24 months
Title
Marginal bone level changes
Description
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.
Time Frame
6 and 12 months
Title
Pain perception: Visual Analogue Scale
Description
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.
Time Frame
Immediately after intervention
Title
Limitations in daily activity
Description
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.
Time Frame
7 days
Title
Taste alteration
Description
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.
Time Frame
7 days
Title
Taste sensation
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Galeazzi
City
Milan
ZIP/Postal Code
20161
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigators planned to share anonymized IPD after the end of the study

Learn more about this trial

Non-surgical Treatment of Peri-implant Mucositis

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