Skip to main content
OpenTrials
Completed

NCT Number: NCT05307445

Treatment of Peri-Implant Mucositis With Standard of Care and Bioptron Hyperlight Therapy

Objectives:

The aim of this study was to evaluate in a cohort of patients with peri-implant mucositis: (a) the efficacy of professional mechanical debridement therapy assisted using Bioptron Hyperlight Therapy on the reduction of periodontal indexes (b) the reduction of total oxidative salivary stress.

Material and Methods Forty subjects with a diagnosis of peri-implant mucositis were enrolled in this study and randomly assigned to the study group (mechanical debridement therapy assisted using Bioptron Hyperlight Therapy) or control group (mechanical debridement therapy alone). The study duration was 6 months. Data on plaque index (PI), bleeding on probing (BoP), probing pocket depth (PPD) and pain relief on Visual Analogue Scale (VAS) were recorded at T0, T1 (14 days), T2 (1 month) and T3 (6 months). Group differences were assessed using Student's t-test and Pearson's Chi-squared test of homogeneity

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mucositis Oral Dental Implant Failed Mouth Diseases Stomatitis Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roberto Felice Grassi

Bari, 70121, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, 30-60 years old.
  • With diagnosis of peri-implant mucositis.
  • Plaque index (PI) ≥ 40%.
  • Al least one implant site with PPD≥4 mm, BOP+ and suppuration.
  • No uncontrolled diabetes, cardiovascular diseases, bone metabolism disorders, no autoimmune diseases (lichen planus, pemphigoid, pemphigus and systemic lupus erythematosus).
  • No pharmacological therapies, no chemo-radiotherapies.
  • No smoking (>10 cigarettes/day), alcohol and/or drug consumption.
  • No pregnancy or breastfeeding.
  • No allergy.

Exclusion criteria

-

Treatment and study plan

Photobiomodulation with Bioptron Hyperlight Therapy

Device

The Bioptron® Device provides polarized visible polychromatic noncoherent light with 90 W; light wavelength = 480-3400 nm; degree of polarization = 95%; specific power = 40 mW/cm2; energy density = 2.4 J/cm2. The duration of each treatment session was 10 min. Bioptron light was positioned 10 cm from the oral mucosa and a mouth opener was positioned for the entire duration of the session. Two weekly sessions during the first 4 weeks of treatment were applied.

Primary outcomes

  1. Periodontal chart-Probing pocket depth (PPD)

    Time frame: Patients were assessed before study beginning (baseline)

    Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.

  2. Periodontal chart-Probing pocket depth (PPD)

    Time frame: Patients were assessed at 6 weeks (T1)

    Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.

  3. Periodontal chart-Probing pocket depth (PPD)

    Time frame: Patients were assessed at 12 weeks (T2)

    Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.

  4. Periodontal chart-Probing pocket depth (PPD)

    Time frame: Patients were assessed at 24 weeks (T3)

    Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.

  5. Periodontal chart-Bleeding on probing (BOP)

    Time frame: Patients were assessed before study beginning (baseline)

    Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is :

    • 0: normal colour of gingiva, no inflammation, no bleeding;
    • 1: slight inflammation; no bleeding;
    • 2: moderate inflammation; presence of bleeding on probing;
    • 3: severe inflammation; tendency to spontaneus bleeding.

  6. Periodontal chart-Bleeding on probing (BOP)

    Time frame: Patients were assessed at 6 weeks (T1)

    Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is :

    • 0: normal colour of gingiva, no inflammation, no bleeding;
    • 1: slight inflammation; no bleeding;
    • 2: moderate inflammation; presence of bleeding on probing;
    • 3: severe inflammation; tendency to spontaneus bleeding.

  7. Periodontal chart-Bleeding on probing (BOP)

    Time frame: Patients were assessed at 12 weeks (T2)

    Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is :

    • 0: normal colour of gingiva, no inflammation, no bleeding;
    • 1: slight inflammation; no bleeding;
    • 2: moderate inflammation; presence of bleeding on probing;
    • 3: severe inflammation; tendency to spontaneus bleeding.

  8. Periodontal chart-Bleeding on probing (BOP)

    Time frame: Patients were assessed at 24 weeks (T3)

    Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is :

    • 0: normal colour of gingiva, no inflammation, no bleeding;
    • 1: slight inflammation; no bleeding;
    • 2: moderate inflammation; presence of bleeding on probing;
    • 3: severe inflammation; tendency to spontaneus bleeding.

  9. Periodontal chart- Plaque index (PI)

    Time frame: Patients were assessed before study beginning (baseline)

    Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is :

    • 0: no visible plaque;
    • 1: thin plaque layer detectable by scraping;
    • 2: moderate plaque layer; visible to the naked eye;
    • 3: abundant plaque layer.

  10. Periodontal chart- Plaque index (PI)

    Time frame: Patients were assessed at 6 weeks (T1)

    Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is :

    • 0: no visible plaque;
    • 1: thin plaque layer detectable by scraping;
    • 2: moderate plaque layer; visible to the naked eye;
    • 3: abundant plaque layer.

  11. Periodontal chart- Plaque index (PI)

    Time frame: Patients were assessed at 12 weeks (T2)

    Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is :

    • 0: no visible plaque;
    • 1: thin plaque layer detectable by scraping;
    • 2: moderate plaque layer; visible to the naked eye;
    • 3: abundant plaque layer.

  12. Periodontal chart- Plaque index (PI)

    Time frame: Patients were assessed at 24 weeks (T3)

    Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is :

    • 0: no visible plaque;
    • 1: thin plaque layer detectable by scraping;
    • 2: moderate plaque layer; visible to the naked eye;
    • 3: abundant plaque layer.

Secondary outcomes

  1. Pain relief

    Time frame: Patients were assessed before study beginning (baseline)

    Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)

  2. Pain relief

    Time frame: Patients were assessed at 6 weeks (T1)

    Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)

  3. Pain relief

    Time frame: Patients were assessed at 12 weeks (T2)

    Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)

  4. Pain relief

    Time frame: Patients were assessed at 24 weeks (T3)

    Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Treatment of Peri-Implant Mucositis With Standard of Care and Bioptron Hyperlight Therapy: A Parallel-Arm Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 1, 2022
Registry last updated
Apr 1, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.