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Completed

NCT Number: NCT07212855

Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol

Dental implants are widely employed in modern dentistry for the rehabilitation of patients affected by edentulism, whether limited to a single missing tooth, multiple adjacent teeth, or involving complete dental arches. In particular, full-arch rehabilitations provide both functional and aesthetic restoration of completely edentulous arches or of severely compromised dentitions that the preservation of the remaining teeth is no longer clinically feasible.

Among the various treatment strategies available, the Columbus Bridge Protocol™ represents an established implant-prosthetic approach for full-arch rehabilitation through the use of implant-supported prostheses with immediate functional loading.

The non-surgical management of peri-implant diseases can be performed using a variety of tools, which are considered equivalent in effectiveness when used individually, according to the Guidelines for the Prevention and Treatment of Peri-implant Diseases. These include ultrasonic devices with implant-specific tips, titanium curettes, chitosan brushes, and air-polishing systems using glycine-based powders.

These instruments effectively remove biofilm and deposits without compromising the implant surface, unlike stainless steel curettes, which can induce microscopic alterations. Such alterations may facilitate microbial colonization and complicate effective biofilm removal.

In particular, for the removal of soft deposits, air-polishing devices with glycine powder have been shown to reduce clinical signs of inflammation in cases of peri-implant mucositis and may enhance the efficacy of non-surgical therapy in peri-implantitis. Furthermore, the use of fine-grain powders such as glycine does not cause surface alterations to the hard tissues of natural teeth or to titanium implant surfaces, nor does it lead to epithelial erosion of the soft tissues.

In patients with full-arch implant-supported prostheses, air-polishing devices represent an effective method for professional oral hygiene, including the prosthetic-mucosal interface, without requiring prosthesis removal.

Regarding home oral hygiene, the Guidelines for the Prevention and Treatment of Peri-implant Diseases do not provide universally applicable recommendations. Instead, they emphasize the importance of personalized instructions and motivation strategies, tailored to the individual needs of each patient.

For patients rehabilitated with full-arch implant-supported prostheses, in addition to compliance, prosthetic design must ensure adequate cleanability. Ideally, designs should avoid the reconstruction of soft tissues, thereby facilitating daily hygiene procedures.

The primary home-care tools recommended for these patients include manual or electric toothbrushes, sponge dental floss, and interdental brushes. The use of an angled toothbrush has also been suggested to improve access to difficult areas, such as prosthetic surfaces in direct contact with the mucosa and distal cantilevers.

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Key information

Conditions

Full Arch Fixed Prosthesis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Città della Salute e della Scienza

Torino, Italy, 10126

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • good general health (classified as ASA Physical Status ≤ 2, according to the American Society of Anesthesiology),
  • patients with implant-supported prosthetic rehabilitation completed following the Columbus Bridge Protocol at least six months prior to enrollment

Exclusion criteria

  • patients under the age of 18; heavy tobacco smokers (≥10 cigarettes per day);
  • pregnant or breastfeeding women;
  • individuals with autoimmune diseases, with or without oral tissue involvement;
  • patients presenting biological complications (such as lack of osseointegration, implant mobility, or implant loss) affecting one or more implants;
  • cases of peri-implantitis involving at least one implant; individuals with less than 40% peri-implant bone support as measured radiographically;
  • patients taking medications known to induce gingival overgrowth, as well as those undergoing corticosteroid or antibiotic therapy in the three months prior to and during the study period, or receiving antiresorptive drug therapy;
  • individuals with motor, manual, or cognitive impairments;
  • patients whose full-arch implant-supported rehabilitation had been performed at other facilities;
  • individuals with respiratory disorders; and those diagnosed with infectious diseases.

Treatment and study plan

Professional oral hygiene with glycine powder

Procedure

Professional removal of hard and soft deposits using titanium curettes, spongy interdental floss, and air-polishing with glycine powder. The glycine powder used had a particle size of 25 μm and was applied using a supragingival nozzle positioned 3 mm from the prosthetic restoration, with particular attention given to the areas in direct contact with the mucosa.

Domiciliary oral hygiene with angle toothbrush

Device

Patients were motivated and instructed to use an angled-handle toothbrush (Specialist Implant, Curasept S.p.A., Saronno, Italy), in addition to a standard toothbrush and implant floss. The specific design of the angled handle was intended to facilitate access to areas that are difficult to clean. In patients rehabilitated with full-arch implant-supported prostheses, these areas typically include distal cantilevers and surfaces in direct contact with the mucosa.

Primary outcomes

  1. Plaque on implant abutment

    Time frame: 3 months

    Plaque Index was recorded on the implants prior to the implementation of any procedure that could potentially lead to biofilm removal, evaluating six sites per implant. The absence or presence of plaque will be assessed using a periodontal probe. Scores can range from 0 (no tooth surfaces with plaque) to 100 (all tooth surfaces have plaque), where 100 is the worst possible result.

Secondary outcomes

  1. Plaque on prosthesis

    Time frame: 3 months

    A plaque disclosing solution (Mira-2-Ton Solution, Hager & Werken GmbH & Co., Duisburg, Germany) was applied to the surfaces in contact with the mucosa, enabling the detection of residual deposits despite professional oral hygiene procedures. The biofilm was stained in shades of pink, purple, and blue.

    The prosthetic framework was analyzed using ImageJ software version 1.45s (National Institutes of Health, Bethesda, MD, USA). Following the upload of a photograph - captured with a Nikon D7500 camera equipped with a Nikon AF-S Micro NIKKOR 85 mm f/3.5G lens, with the prosthetic component placed on a flat surface covered with a green fabric and the camera positioned perpendicularly to the surface - pixels corresponding exclusively to pink, violet, and blue shades were selected, thereby isolating the plaque-stained areas. Similarly, a selection was performed to include only green pixels, corresponding to the background fabric, in order to exclude the prosthesis from the selection.

    Subsequ

  2. Bleeding on probing on implant abutment

    Time frame: 3 months

    Bleeding on Probing was assessed by the presence of bleeding within 30 seconds after probing on six sites each implant.

  3. Probing depth on implant abutment

    Time frame: 3 months

    Probing Depth was measured as the distance between the tip of the probe inserted into the sulcus and the margin of the peri-implant mucosa, applying an insertion force of approximately 0.2 N, at six sites per implant

  4. Keratinized mucosa

    Time frame: 3 months

    Keratinized Tissue was measured as the distance between the peri-implant mucosal margin and the mucogingival junction at the buccal site of each implant.

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Analysis of the Effectiveness of the Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol: a Factorial Randomized Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2025
Registry last updated
May 5, 2026

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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