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

NCT05307445 | Completed DMC

• 1 other identifier: 3464/23.12.2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Mucositis Oral; Dental Implant Failed

Keywords

peri-implant mucositis; dental implants; Bioptron; photobiomodulation

Outcome Measures

Primary Outcomes (12)

• 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.

  Patients were assessed before study beginning (baseline)

• 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.

  Patients were assessed at 6 weeks (T1)

• 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.

  Patients were assessed at 12 weeks (T2)

• 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.

  Patients were assessed at 24 weeks (T3)

• 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.

  Patients were assessed before study beginning (baseline)

• 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.

  Patients were assessed at 6 weeks (T1)

• 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.

  Patients were assessed at 12 weeks (T2)

• 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.

  Patients were assessed at 24 weeks (T3)

• 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.

  Patients were assessed before study beginning (baseline)

• 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.

  Patients were assessed at 6 weeks (T1)

• 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.

  Patients were assessed at 12 weeks (T2)

• 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.

  Patients were assessed at 24 weeks (T3)

Secondary Outcomes (4)

• Pain relief

  Patients were assessed before study beginning (baseline)

• Pain relief

  Patients were assessed at 6 weeks (T1)

• Pain relief

  Patients were assessed at 12 weeks (T2)

• Pain relief

  Patients were assessed at 24 weeks (T3)

Study Arms (2)

peri-implant mucositis treated with standard of care-professional mechanical debridement

ACTIVE COMPARATOR

patients with peri-implant mucositis are treated with standard of care, i.e. professional mechanical debridement

Device: Photobiomodulation with Bioptron Hyperlight Therapy

peri-implant mucositis treated with photobiomodulation in addition to standard treatment

EXPERIMENTAL

patients with peri-implant mucositis are treated with photobiomodulation in addition to standard treatment

Device: Photobiomodulation with Bioptron Hyperlight Therapy

Interventions

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.

peri-implant mucositis treated with photobiomodulation in addition to standard treatment; peri-implant mucositis treated with standard of care-professional mechanical debridement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Roberto Felice Grassi

Bari, 70121, Italy

Location

Related Publications (1)

• 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.

  PMID: 35565077 DERIVED

MeSH Terms

Conditions

Stomatitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Roberto F Grassi, Prof

  University of Bari Aldo Moro

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: a randomised, double blind clinical trial

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 1, 2022
• Study Start: January 7, 2020
• Primary Completion: January 10, 2021
• Study Completion: January 13, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)