Plaque, DentalNCT05965076
Analysis of the Effectiveness of the Use of Glycine Powder and Angled Implant Brush in Oral Hygiene Maintenance in Patients Reinstated With Columbus Bridge ProtocolTM
A study testing Glycine Perio Flow, Angled Toothbrush and Standard Professional Oral Hygiene in people with Plaque, Dental, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
This study aims at comparing different procedures of Professional Oral Hygiene (POH) and Domiciliary Oral Hygiene (DOH) in Columbus Bridge ProtocolTM full-arch reinstated patients by dividing a sample of at least 74 patients into 4 groups with a 1:1:1:1 ratio. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Plaque, Dental
- What is being tested?
- Glycine Perio Flow, Angled Toothbrush and Standard Professional Oral Hygiene
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteItaly
- Study dates
- 6 Feb 2023to 15 Dec 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age >= 18years
- Good systemic health, with ASA classification <= 2
- Columbus Bridge ProtocolTM reinstation from at least six months
Who cannot join
- Heavy smokers (>= 10 cigarettes per day)
- Pregnancy or breastfeeding
- Autoimmune diseases with or without oral involvement
- Biological complications on at least one of the dental implants
- Perimplantits diagnosis, defined according to Lindhe et al's criteria [5]
- Radicular bone <4mm, evaluated by means of RX
Show all 11Show fewer
- Use of gingival overgrowth inducing drugs
- Cognitive or motor impairments
- Full-arch reinstations performed in other structures
- Respiratory issues
- Infective diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
S.C. Riabilitazione Orale Protesi Maxillo-Facciale e Implantologia Dentaria
Torino, 10126
Armando Crupi, Dr., +39 0116331531, armando.crupi@unito.it
Jacopo Lanzetti, Dr., +39 0116331531, jacopo.lanzetti@unito.it
About this study
Official title: Analysis of the Effectiveness of the Use of Glycine Powder and Angled Implant Brush in Oral Hygiene Maintenance in Patients Reinstated With Columbus Bridge ProtocolTM: a Factorial Randomized Study
This study aims at comparing different procedures of Professional Oral Hygiene (POH) and Domiciliary Oral Hygiene (DOH) in Columbus Bridge ProtocolTM full-arch reinstated patients by dividing a sample of at least 74 patients into 4 groups with a 1:1:1:1 ratio. The patients will randomly be assigned to a "Standard" or "Glycine Perio Flow" Professional treatment, and to a "Standard" or "Angled" Toothbrush for their Domiciliary oral hygiene.
Data about bacterial plaque presence is collected both before and after unscrewing the denture, when it comes to implant abutments. Instead, Denture Plaque Index will be collected after unscrewing the denture, by means of erythrosine and analyzed using a specific software that allows to compute the percentage of plaque on the denture.
Read more
Patients will be seen after 3 months in order to figure out differences between DOH groups, by measuring plaque on abutments and on the denture after unscrewing it.
At the moment there are no scientific studies trying to determine which professional and domiciliary procedures might be more efficient to control bacterial plaque in Columbus Bridge ProtocolTM reinstated patients.
Statistically significant lower Plaque Index (PI) and Denture Plaque Index (DPI) scores are expected in patients treated with glycine perio flow, compared to standard treated patients. However, when it comes to angled toothbrush, lower PI and DPI are expected not to be statistically significant.
Expectation from this study is to get information on how to improve full-arch patients' therapy in order to reduce peri-implant diseases which are related to bacterial plaque.
- Conditions
- Plaque, Dental
- Being tested
- Glycine Perio Flow, Angled Toothbrush, Standard Professional Oral Hygiene, Standard Domiciliary Oral Hygiene
- Keywords
- glycine, airflow, full-arch, angled toothbrush
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycine Perio FlowProcedure or surgery
Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss and glycine perio-flow.
Angled ToothbrushBehavioural
Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and an angled toothbrush.
Standard Professional Oral HygieneProcedure or surgery
Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss.
Standard Domiciliary Oral HygieneBehavioural
Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and a standard toothbrush.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Patients will be professionally treated with standard dental hygiene treatment, and they will use a standard toothbrush for their domiciliary oral hygiene. Receives: Procedure: Standard Professional Oral Hygiene; Behavioral: Standard Domiciliary Oral Hygiene |
| Glycine | Experimental | Patients will be professionally treated by adding glycine perio-flow in the treatment, and they will use a standard toothbrush for their domiciliary oral hygiene. Receives: Procedure: Glycine Perio Flow; Behavioral: Standard Domiciliary Oral Hygiene |
| Angled toothbrush | Experimental | Patients will be professionally treated with standard dental hygiene treatment, and they will use an angled toothbrush for their domiciliary oral hygiene. Receives: Behavioral: Angled Toothbrush; Procedure: Standard Professional Oral Hygiene |
| Glycine - Angled toothbrush | Experimental | Patients will be professionally treated by adding glycine perio-flow in the treatment, and they will use an angled toothbrush for their domiciliary oral hygiene. Receives: Procedure: Glycine Perio Flow; Behavioral: Angled Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Denture Plaque Index (DPI)
This study's primary outcome is the plaque index on the denture (DPI). Plaque indexes will be determined by means of erythrosine (GC Tri Plaque ID GelTM, Tokyo, Japan).
Pictures in jpg format will be taken with a digital Nikon D80 camera with 105mm macro lens and processed with ImageJ 1.45s software (National Institutes of Health, Bethesda, MD, USA). Pictures will be converted into binary monochrome images. Specific standard thresholds will be determined to differentiate the plaque pixels (blue) from the plaque free ones (pink). This procedure is already proven by literature.
Measured: T0: first session (for professional oral hygiene).
Denture Plaque Index (DPI)
This study's primary outcome is the plaque index on the denture (DPI). Plaque indexes will be determined by means of erythrosine (GC Tri Plaque ID GelTM, Tokyo, Japan).
Pictures in jpg format will be taken with a digital Nikon D80 camera with 105mm macro lens and processed with ImageJ 1.45s software (National Institutes of Health, Bethesda, MD, USA). Pictures will be converted into binary monochrome images. Specific standard thresholds will be determined to differentiate the plaque pixels (blue) from the plaque free ones (pink). This procedure is already proven by literature.
Measured: T1: second session, after 3 months (for domiciliary oral hygiene).
Secondary outcomes (6)
Probing Depth (PD);
Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Probing depth is evaluated in mm.
Measured: T0: first session (for professional oral hygiene).
Probing Depth (PD);
Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Probing depth is evaluated in mm.
Measured: T1: second session, after 3 months (for domiciliary oral hygiene).
Bleeding on Probing (BoP);
Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Bleeding on probing is evaluated as presence of bleeding (yes/no).
Measured: T0: first session (for professional oral hygiene).
Bleeding on Probing (BoP);
Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Bleeding on probing is evaluated as presence of bleeding (yes/no).
Measured: T1: second session, after 3 months (for domiciliary oral hygiene).
Plaque Index on implant abutments
Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. PI is defined as plaque presence (yes/no) on the abutment or denture by means of erythrosine gel.
Measured: T0: first session (for professional oral hygiene).
Plaque Index on implant abutments
Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. PI is defined as plaque presence (yes/no) on the abutment or denture by means of erythrosine gel.
Measured: T1: second session, after 3 months (for domiciliary oral hygiene).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start6 Feb 2023
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Plaque, DentalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crupi Armando, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965076
- Sponsor's protocol ID
- 99110619
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.
PubMed 18724855Abi Nader S, Eimar H, Momani M, Shang K, Daniel NG, Tamimi F. Plaque Accumulation Beneath Maxillary All-on-4 Implant-Supported Prostheses. Clin Implant Dent Relat Res. 2015 Oct;17(5):932-7. doi: 10.1111/cid.12199. Epub 2014 Jan 27.
PubMed 24461161Mensi M, Scotti E, Sordillo A, Agosti R, Calza S. Plaque disclosing agent as a guide for professional biofilm removal: A randomized controlled clinical trial. Int J Dent Hyg. 2020 Aug;18(3):285-294. doi: 10.1111/idh.12442. Epub 2020 May 26.
PubMed 32348624
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. 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 Angled Implant Brush in Oral Hygiene Maintenance in Patients Reinstated With Columbus Bridge ProtocolTM: a Factorial Randomized Study
- ClinicalTrials.gov ID
- NCT05965076
- Acronym / sponsor ID
- 99110619
- Conditions
- Plaque, Dental
- Keywords
- glycine, airflow, full-arch, angled toothbrush
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 28 Jul 2023 (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.
This study aims at comparing different procedures of Professional Oral Hygiene (POH) and Domiciliary Oral Hygiene (DOH) in Columbus Bridge ProtocolTM full-arch reinstated patients by dividing a sample of at least 74 patients into 4 groups with a 1:1:1:1 ratio. The patients will randomly be assigned to a "Standard" or "Glycine Perio Flow" Professional treatment, and to a "Standard" or "Angled" Toothbrush for their Domiciliary oral hygiene.
Data about bacterial plaque presence is collected both before and after unscrewing the denture, when it comes to implant abutments. Instead, Denture Plaque Index will be collected after unscrewing the denture, by means of erythrosine and analyzed using a specific software that allows to compute the percentage of plaque on the denture.
Patients will be seen after 3 months in order to figure out differences between DOH groups, by measuring plaque on abutments and on the denture after unscrewing it.
At the moment there are no scientific studies trying to determine which professional and domiciliary procedures might be more efficient to control bacterial plaque in Columbus Bridge ProtocolTM reinstated patients.
Statistically significant lower Plaque Index (PI) and Denture Plaque Index (DPI) scores are expected in patients treated with glycine perio flow, compared to standard treated patients. However, when it comes to angled toothbrush, lower PI and DPI are expected not to be statistically significant.
Expectation from this study is to get information on how to improve full-arch patients' therapy in order to reduce peri-implant diseases which are related to bacterial plaque.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Procedure: Standard Professional Oral Hygiene, Behavioral: Standard Domiciliary Oral HygienePatients will be professionally treated with standard dental hygiene treatment, and they will use a standard toothbrush for their domiciliary oral hygiene. |
| Glycine | Experimental | Procedure: Glycine Perio Flow, Behavioral: Standard Domiciliary Oral HygienePatients will be professionally treated by adding glycine perio-flow in the treatment, and they will use a standard toothbrush for their domiciliary oral hygiene. |
| Angled toothbrush | Experimental | Behavioral: Angled Toothbrush, Procedure: Standard Professional Oral HygienePatients will be professionally treated with standard dental hygiene treatment, and they will use an angled toothbrush for their domiciliary oral hygiene. |
| Glycine - Angled toothbrush | Experimental | Procedure: Glycine Perio Flow, Behavioral: Angled ToothbrushPatients will be professionally treated by adding glycine perio-flow in the treatment, and they will use an angled toothbrush for their domiciliary oral hygiene. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 18years
- Good systemic health, with ASA classification <= 2
- Columbus Bridge ProtocolTM reinstation from at least six months
Key exclusion criteria (11 listed)
- Heavy smokers (>= 10 cigarettes per day)
- Pregnancy or breastfeeding
- Autoimmune diseases with or without oral involvement
- Biological complications on at least one of the dental implants
- Perimplantits diagnosis, defined according to Lindhe et al's criteria [5]
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 |
|---|---|---|
| Glycine Perio FlowProfessional plaque and tartar removal by means of titanium curettes, bridge and implant floss and glycine perio-flow. | Procedure or surgery | Glycine, Glycine - Angled toothbrush |
| Angled ToothbrushPatients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and an angled toothbrush. | Behavioural | Angled toothbrush, Glycine - Angled toothbrush |
| Standard Professional Oral HygieneProfessional plaque and tartar removal by means of titanium curettes, bridge and implant floss. | Procedure or surgery | Angled toothbrush, Standard |
| Standard Domiciliary Oral HygienePatients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and a standard toothbrush. | Behavioural | Glycine, Standard |
Primary outcome
Denture Plaque Index (DPI)
Time frame: T0: first session (for professional oral hygiene).
This study's primary outcome is the plaque index on the denture (DPI). Plaque indexes will be determined by means of erythrosine (GC Tri Plaque ID GelTM, Tokyo, Japan). Pictures in jpg format will be taken with a digital Nikon D80 camera with 105mm macro lens and processed with ImageJ 1.45s software (National Institutes of Health, Bethesda, MD, USA). Pictures will be converted into binary monochrome images. Specific standard thresholds will be determined to differentiate the plaque pixels (blue) from the plaque free ones (pink). This procedure is already proven by literature.
Denture Plaque Index (DPI)
Time frame: T1: second session, after 3 months (for domiciliary oral hygiene).
This study's primary outcome is the plaque index on the denture (DPI). Plaque indexes will be determined by means of erythrosine (GC Tri Plaque ID GelTM, Tokyo, Japan). Pictures in jpg format will be taken with a digital Nikon D80 camera with 105mm macro lens and processed with ImageJ 1.45s software (National Institutes of Health, Bethesda, MD, USA). Pictures will be converted into binary monochrome images. Specific standard thresholds will be determined to differentiate the plaque pixels (blue) from the plaque free ones (pink). This procedure is already proven by literature.
6 secondary outcomes
Probing Depth (PD);
Time frame: T0: first session (for professional oral hygiene).
Probing Depth (PD);
Time frame: T1: second session, after 3 months (for domiciliary oral hygiene).
Bleeding on Probing (BoP);
Time frame: T0: first session (for professional oral hygiene).
Bleeding on Probing (BoP);
Time frame: T1: second session, after 3 months (for domiciliary oral hygiene).
Plaque Index on implant abutments
Time frame: T0: first session (for professional oral hygiene).
Plaque Index on implant abutments
Time frame: T1: second session, after 3 months (for domiciliary oral hygiene).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Results publication: PubMed 18724855Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.
- Results publication: PubMed 24461161Abi Nader S, Eimar H, Momani M, Shang K, Daniel NG, Tamimi F. Plaque Accumulation Beneath Maxillary All-on-4 Implant-Supported Prostheses. Clin Implant Dent Relat Res. 2015 Oct;17(5):932-7. doi: 10.1111/cid.12199. Epub 2014 Jan 27.
- Results publication: PubMed 32348624Mensi M, Scotti E, Sordillo A, Agosti R, Calza S. Plaque disclosing agent as a guide for professional biofilm removal: A randomized controlled clinical trial. Int J Dent Hyg. 2020 Aug;18(3):285-294. doi: 10.1111/idh.12442. Epub 2020 May 26.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycine Perio Flow, Angled Toothbrush and Standard Professional Oral Hygiene in people with Plaque, Dental, run by A.O.U. Città della Salute e della Scienza 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Armando Crupi, Dr. (+39 0116331531, armando.crupi@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Denture Plaque Index (DPI) (time frame: T0: first session (for professional oral hygiene).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05965076, which also lists 3 linked publications.
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 23 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.