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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Plaque, Dental

Intervention / Treatment
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* Procedure: Glycine Perio Flow
* Behavioral: Angled Toothbrush
* Procedure: Standard Professional Oral Hygiene
* Behavioral: Standard Domiciliary Oral Hygiene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 18years Good systemic health, with ASA classification <= 2 Columbus Bridge ProtocolTM reinstation from at least six months Exclusion Criteria: 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 Use of gingival overgrowth inducing drugs Cognitive or motor impairments Full-arch reinstations performed in other structures Respiratory issues Infective diseases
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>Patients will be professionally treated with standard dental hygiene treatment, and they will use a standard toothbrush for their domiciliary oral hygiene. | Procedure: Standard Professional Oral Hygiene<br>* Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss.<br>Behavioral: Standard Domiciliary Oral Hygiene<br>* Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and a standard toothbrush.<br>|
| Experimental: Glycine<br>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. | Procedure: Glycine Perio Flow<br>* Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss and glycine perio-flow.<br>Behavioral: Standard Domiciliary Oral Hygiene<br>* Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and a standard toothbrush.<br>|
| Experimental: Angled toothbrush<br>Patients will be professionally treated with standard dental hygiene treatment, and they will use an angled toothbrush for their domiciliary oral hygiene. | Behavioral: Angled Toothbrush<br>* Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and an angled toothbrush.<br>Procedure: Standard Professional Oral Hygiene<br>* Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss.<br>|
| Experimental: Glycine - Angled toothbrush<br>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. | Procedure: Glycine Perio Flow<br>* Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss and glycine perio-flow.<br>Behavioral: Angled Toothbrush<br>* Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and an angled toothbrush.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | T1: second session, after 3 months (for domiciliary oral hygiene). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | 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). | 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. | 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. | T1: second session, after 3 months (for domiciliary oral hygiene). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glycine, airflow, full-arch, angled toothbrush