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

NCT ID: NCT07212855

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-06-15

Brief Summary

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.

Conditions

Full Arch Fixed Prosthesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

professional oral hygiene with glycine and domiciliary oral hygiene with angle toothbrush

Patients randomized to the Test group for professional oral hygiene underwent 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.

Patients randomized to the Test group for domiciliary oral hygiene procedures - 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.

Group Type: EXPERIMENTAL

Professional oral hygiene with glycine powder

Intervention Type: 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

Intervention Type: 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.

professional oral hygiene with glycine and domiciliary oral hygiene with standard toothbrush

Patients randomized to the Test group for professional oral hygiene underwent 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.

Patients randomized to the Control group for domiciliary oral hygiene procedures were motivated exclusively to use a standard toothbrush and implant floss.

Group Type: ACTIVE_COMPARATOR

Professional oral hygiene with glycine powder

Intervention Type: 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.

professional oral hygiene without glycine and domiciliary oral hygiene with angle toothbrush

Patients randomized to the Control group for professional oral hygiene underwent professional removal of hard and soft deposits exclusively by means of titanium curettes and spongy interdental floss.

Patients randomized to the Test group for domiciliary oral hygiene procedures - 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.

Group Type: ACTIVE_COMPARATOR

Domiciliary oral hygiene with angle toothbrush

Intervention Type: 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.

professional oral hygiene without glycine and domiciliary oral hygiene with standard toothbrush

Patients randomized to the Control group for professional oral hygiene underwent professional removal of hard and soft deposits exclusively by means of titanium curettes and spongy interdental floss.

Patients randomized to the Control group for domiciliary oral hygiene procedures were motivated exclusively to use a standard toothbrush and implant floss.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Professional oral hygiene with glycine powder

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.

Intervention Type: PROCEDURE

Domiciliary oral hygiene with angle toothbrush

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Jacopo Lanzetti

Doctor in Dental Hygiene

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AOU Città della Salute e della Scienza

Torino, Italy, Italy

Countries

Italy

Other Identifiers

134/2023

Identifier Type: -

Identifier Source: org_study_id