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Completed

NCT Number: NCT03915665

Non-surgical Treatment of Peri-implant Mucositis

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.

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Key information

Conditions

Peri-implant Mucositis

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Chlorhexidine

Drug

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

Air-powder

Device

Erythritol powder using air-powder device

Primary outcomes

  1. Bleeding index change

    Time frame: 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 outcomes

  1. PPD changes

    Time frame: 2 weeks, 1 month, 3, 6, 12, 24 months

    Changes in peri-implant probing depth between baseline and follow-up visit

  2. Tissue level changes

    Time frame: 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

  3. PI changes

    Time frame: 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.)

  4. BI changes

    Time frame: 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.

  5. Marginal bone level changes

    Time frame: 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.

  6. Pain perception: Visual Analogue Scale

    Time frame: 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.

  7. Limitations in daily activity

    Time frame: 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.

  8. Taste alteration

    Time frame: 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.

  9. Taste sensation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 16, 2019
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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