AzTrials
AzTrials

Mucositis OralNCT05307445

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

A study testing Photobiomodulation with Bioptron Hyperlight Therapy in people with Mucositis Oral and Dental Implant Failed, run by University of Roma La Sapienza at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Mucositis Oral, Dental Implant Failed
What is being tested?
Photobiomodulation with Bioptron Hyperlight Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteItaly
Study dates
7 Jan 2020to 13 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • No smoking (>10 cigarettes/day), alcohol and/or drug consumption.
  • No pregnancy or breastfeeding.
  • No allergy.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Roberto Felice Grassi

    Bari, 70121

Other trials in Italy

About this study

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

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

Being tested
Photobiomodulation with Bioptron Hyperlight Therapy
Keywords
peri-implant mucositis, dental implants, Bioptron, photobiomodulation
Medical subject headings
Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Photobiomodulation with Bioptron Hyperlight TherapyDevice

    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.

Study groups in NCT05307445
Study groupRoleWhat they receive
peri-implant mucositis treated with standard of care-professional mechanical debridementActive comparatorpatients with peri-implant mucositis are treated with standard of care, i.e. professional mechanical debridement
Receives: Device: Photobiomodulation with Bioptron Hyperlight Therapy
peri-implant mucositis treated with photobiomodulation in addition to standard treatmentExperimentalpatients with peri-implant mucositis are treated with photobiomodulation in addition to standard treatment
Receives: Device: Photobiomodulation with Bioptron Hyperlight Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Periodontal chart-Probing pocket depth (PPD)

    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.

    Measured: Patients were assessed before study beginning (baseline)

  2. Periodontal chart-Probing pocket depth (PPD)

    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.

    Measured: Patients were assessed at 6 weeks (T1)

  3. Periodontal chart-Probing pocket depth (PPD)

    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.

    Measured: Patients were assessed at 12 weeks (T2)

  4. Periodontal chart-Probing pocket depth (PPD)

    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.

    Measured: Patients were assessed at 24 weeks (T3)

  5. Periodontal chart-Bleeding on probing (BOP)

    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.

    Measured: Patients were assessed before study beginning (baseline)

  6. Periodontal chart-Bleeding on probing (BOP)

    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.

    Measured: Patients were assessed at 6 weeks (T1)

  7. Periodontal chart-Bleeding on probing (BOP)

    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.

    Measured: Patients were assessed at 12 weeks (T2)

  8. Periodontal chart-Bleeding on probing (BOP)

    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.

    Measured: Patients were assessed at 24 weeks (T3)

  9. Periodontal chart- Plaque index (PI)

    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.

    Measured: Patients were assessed before study beginning (baseline)

  10. Periodontal chart- Plaque index (PI)

    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.

    Measured: Patients were assessed at 6 weeks (T1)

  11. Periodontal chart- Plaque index (PI)

    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.

    Measured: Patients were assessed at 12 weeks (T2)

  12. Periodontal chart- Plaque index (PI)

    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.

    Measured: Patients were assessed at 24 weeks (T3)

Secondary outcomes (4)

  1. Pain relief

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

    Measured: Patients were assessed before study beginning (baseline)

  2. Pain relief

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

    Measured: Patients were assessed at 6 weeks (T1)

  3. Pain relief

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

    Measured: Patients were assessed at 12 weeks (T2)

  4. Pain relief

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

    Measured: Patients were assessed at 24 weeks (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2022
  2. Study start7 Jan 2020
  3. Primary completion10 Jan 2021
  4. Study completion13 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
a randomised, double blind clinical trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05307445
Sponsor's protocol ID
3464/23.12.2016
Status last verified
Mar 2022
First submitted
22 Mar 2022
Last updated
1 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nardi GM, Mazur M, Papa G, Petruzzi M, Grassi FR, Grassi R. Treatment of Peri-Implant Mucositis with Standard of Care and Bioptron Hyperlight Therapy: A Randomized Clinical Trial. Int J Environ Res Public Health. 2022 May 7;19(9):5682. doi: 10.3390/ijerph19095682.

    PubMed 35565077

Questions about this trial

What is this clinical trial studying?

A study testing Photobiomodulation with Bioptron Hyperlight Therapy in people with Mucositis Oral and Dental Implant Failed, run by University of Roma La Sapienza at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Periodontal chart-Probing pocket depth (PPD) (time frame: Patients were assessed before study beginning (baseline)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05307445, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in