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
- Conditions
- Plaque, Dental
- Interventions
- Procedure: Glycine Perio FlowProcedure: Standard Professional Oral HygieneBehavioral: Angled ToothbrushBehavioral: Standard Domiciliary Oral Hygiene
- Registration Number
- NCT05965076
- Lead Sponsor
- A.O.U. Città della Salute e della Scienza
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 74
- Age >= 18years
- Good systemic health, with ASA classification <= 2
- Columbus Bridge ProtocolTM reinstation from at least six months
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Glycine Glycine Perio Flow 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. Angled toothbrush Standard Professional Oral Hygiene Patients will be professionally treated with standard dental hygiene treatment, and they will use an angled toothbrush for their domiciliary oral hygiene. Glycine - Angled toothbrush Angled Toothbrush 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. Glycine - Angled toothbrush Glycine Perio Flow 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. Glycine Standard Domiciliary Oral Hygiene 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. Standard Standard Professional Oral Hygiene Patients will be professionally treated with standard dental hygiene treatment, and they will use a standard toothbrush for their domiciliary oral hygiene. Standard Standard Domiciliary Oral Hygiene Patients will be professionally treated with standard dental hygiene treatment, and they will use a standard toothbrush for their domiciliary oral hygiene. Angled toothbrush Angled Toothbrush Patients will be professionally treated with standard dental hygiene treatment, and they will use an angled toothbrush for their domiciliary oral hygiene.
- Primary Outcome Measures
Name Time Method Denture Plaque Index (DPI) 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.
- Secondary Outcome Measures
Name Time Method Probing Depth (PD); T1: second session, after 3 months (for domiciliary oral hygiene). 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.
Plaque Index on implant abutments T1: second session, after 3 months (for domiciliary oral hygiene). 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.
Bleeding on Probing (BoP); T1: second session, after 3 months (for domiciliary oral hygiene). 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).
Trial Locations
- Locations (1)
S.C. Riabilitazione Orale Protesi Maxillo-Facciale e Implantologia Dentaria
🇮🇹Torino, Italy