Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.

NCT04845087 | Completed

• 1 other identifier: 2021-AQUALAB
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants. Patients willl undergo professional dental hygiene also with the use of glycine powders, then they will be randomly divided into two groups:

• Trial Group: irrigation of peri-implant periodontium with mucositis with ozonized water.
• Placebo Group: irrigation of peri-implant periodontium with mucositis with water. Periodontal indices will be recorded at the baseline, after 1 and 2 months. After 1 and 2 months, only glycine powders will be performed, together with ozonized water or water irrigation and the collection of periodontal indices.

Conditions

Peri-implant Mucositis

Keywords

ozonized water

Outcome Measures

Primary Outcomes (4)

• Change in PPD - Probing Depth

  Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus of the peri-implant pocket, evaluated at 6 sites.

  Baseline, 1 and 2 months.

• Change in BOP - Bleeding on Probing (percentage)

  Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PD, detected on 6 sites.

  Baseline, 1 and 2 months.

• Change in BS - Bleeding Score

  Scoring criteria: * 0: no bleeding; * 1: punctiform bleeding in the site of probing; * 2: bleeding within the gingival border; * 3: bleeding outside the gingival border.

  Baseline, 1 and 2 months.

• Change in PI - Plaque Index (percentage)

  Site-specific assessment of the presence or visible plaque detected on 4 sites with a disclosing tables. Percentage of sites with plaque determines the PI%.

  Baseline, 1 and 2 months.

Study Arms (2)

Trial Group

EXPERIMENTAL

Patients from this group will receive treatment with ozonized water.

Other: Ozonized water

Placebo Group

PLACEBO COMPARATOR

Patients from this group will receive placebo with water.

Other: Placebo

Interventions

Ozonized water OTHER

Irrigation of dental implants with ozonized water

Trial Group

Placebo OTHER

Irrigation of dental implants with water

Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of one or more dental implants
• Presence of peri-implant mucositis at least at one implant
• Bleeding Score \> 0

You may not qualify if:

• Patents without dental implants
• Presence of systemic diseases
• Patients with cardiac pacemaker

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

Study Officials

• Andrea Scribante, DDS, PhD.

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Resident, Principal Investigator

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 14, 2021
• Study Start: April 24, 2021
• Primary Completion: July 6, 2021
• Study Completion: July 8, 2021
• Last Updated: July 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)