Full Arch Fixed ProsthesisNCT07212855
Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol
A study testing Professional oral hygiene with glycine powder and Domiciliary oral hygiene with angle toothbrush in people with Full Arch Fixed Prosthesis, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Full Arch Fixed Prosthesis
- What is being tested?
- Professional oral hygiene with glycine powder and Domiciliary oral hygiene with angle toothbrush
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 15 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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
- Being tested
- Professional oral hygiene with glycine powder, Domiciliary oral hygiene with angle toothbrush
- Keywords
- professional oral hygiene, domiciliary oral hygiene, full arch fixed prosthesis, implant disease prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Professional oral hygiene with glycine powderProcedure or surgery
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 toothbrushDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| professional oral hygiene with glycine and domiciliary oral hygiene with angle toothbrush | Experimental | 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. Receives: Procedure: Professional oral hygiene with glycine powder; Device: Domiciliary oral hygiene with angle toothbrush |
| professional oral hygiene with glycine and domiciliary oral hygiene with standard toothbrush | Active comparator | 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. Receives: Procedure: Professional oral hygiene with glycine powder |
| professional oral hygiene without glycine and domiciliary oral hygiene with angle toothbrush | Active comparator | 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. Receives: Device: Domiciliary oral hygiene with angle toothbrush |
| professional oral hygiene without glycine and domiciliary oral hygiene with standard toothbrush | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque on implant abutment
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.
Measured: 3 months
Secondary outcomes (4)
Plaque on prosthesis
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
Measured: 3 months
Bleeding on probing on implant abutment
Bleeding on Probing was assessed by the presence of bleeding within 30 seconds after probing on six sites each implant.
Measured: 3 months
Probing depth on implant abutment
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
Measured: 3 months
Keratinized mucosa
Keratinized Tissue was measured as the distance between the peri-implant mucosal margin and the mucogingival junction at the buccal site of each implant.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Sep 2024
- Primary completion1 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full Arch Fixed ProsthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacopo Lanzetti, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212855
- Sponsor's protocol ID
- 134/2023
- Status last verified
- Sep 2025
- First submitted
- 1 Oct 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07212855
- Acronym / sponsor ID
- 134/2023
- Conditions
- Full Arch Fixed Prosthesis
- Keywords
- professional oral hygiene, domiciliary oral hygiene, full arch fixed prosthesis, implant disease prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| professional oral hygiene with glycine and domiciliary oral hygiene with angle toothbrush | Experimental | Procedure: Professional oral hygiene with glycine powder, Device: Domiciliary oral hygiene with angle toothbrushPatients 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. |
| professional oral hygiene with glycine and domiciliary oral hygiene with standard toothbrush | Active comparator | Procedure: Professional oral hygiene with glycine powderPatients 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. |
| professional oral hygiene without glycine and domiciliary oral hygiene with angle toothbrush | Active comparator | Device: Domiciliary oral hygiene with angle toothbrushPatients 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. |
| professional oral hygiene without glycine and domiciliary oral hygiene with standard toothbrush | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Professional oral hygiene with glycine powderProfessional 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. | Procedure or surgery | professional oral hygiene with glycine and domiciliary oral hygiene with angle toothbrush, professional oral hygiene with glycine and domiciliary oral hygiene with standard toothbrush |
| Domiciliary oral hygiene with angle toothbrushPatients 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. | Device | professional oral hygiene with glycine and domiciliary oral hygiene with angle toothbrush, professional oral hygiene without glycine and domiciliary oral hygiene with angle toothbrush |
Primary outcome
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.
4 secondary outcomes
Plaque on prosthesis
Time frame: 3 months
Bleeding on probing on implant abutment
Time frame: 3 months
Probing depth on implant abutment
Time frame: 3 months
Keratinized mucosa
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Professional oral hygiene with glycine powder and Domiciliary oral hygiene with angle toothbrush in people with Full Arch Fixed Prosthesis, run by University of Turin, Italy 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 2 inclusion and 9 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 5 May 2026. 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?
Plaque on implant abutment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026.