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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

Primary Purpose

Plaque, Dental

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Glycine Perio Flow
Angled Toothbrush
Standard Professional Oral Hygiene
Standard Domiciliary Oral Hygiene
Sponsored by
Azienda Ospedaliera Città della Salute e della Scienza di Torino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Plaque, Dental focused on measuring glycine, airflow, full-arch, angled toothbrush

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • S.C. Riabilitazione Orale Protesi Maxillo-Facciale e Implantologia DentariaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Standard

Glycine

Angled toothbrush

Glycine - Angled toothbrush

Arm Description

Patients will be professionally treated with standard dental hygiene treatment, and they will use a standard toothbrush for their 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.

Patients will be professionally treated with standard dental hygiene treatment, and they will use an angled toothbrush for their domiciliary oral hygiene.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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).
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).
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.
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.

Full Information

First Posted
July 6, 2023
Last Updated
July 19, 2023
Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino
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1. Study Identification

Unique Protocol Identification Number
NCT05965076
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque, Dental
Keywords
glycine, airflow, full-arch, angled toothbrush

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Patients will be professionally treated with standard dental hygiene treatment, and they will use a standard toothbrush for their domiciliary oral hygiene.
Arm Title
Glycine
Arm Type
Experimental
Arm Description
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.
Arm Title
Angled toothbrush
Arm Type
Experimental
Arm Description
Patients will be professionally treated with standard dental hygiene treatment, and they will use an angled toothbrush for their domiciliary oral hygiene.
Arm Title
Glycine - Angled toothbrush
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Glycine Perio Flow
Intervention Description
Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss and glycine perio-flow.
Intervention Type
Behavioral
Intervention Name(s)
Angled Toothbrush
Intervention Description
Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and an angled toothbrush.
Intervention Type
Procedure
Intervention Name(s)
Standard Professional Oral Hygiene
Intervention Description
Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss.
Intervention Type
Behavioral
Intervention Name(s)
Standard Domiciliary Oral Hygiene
Intervention Description
Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and a standard toothbrush.
Primary Outcome Measure Information:
Title
Denture Plaque Index (DPI)
Description
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.
Time Frame
T0: first session (for professional oral hygiene).
Title
Denture Plaque Index (DPI)
Description
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.
Time Frame
T1: second session, after 3 months (for domiciliary oral hygiene).
Secondary Outcome Measure Information:
Title
Probing Depth (PD);
Description
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.
Time Frame
T0: first session (for professional oral hygiene).
Title
Probing Depth (PD);
Description
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.
Time Frame
T1: second session, after 3 months (for domiciliary oral hygiene).
Title
Bleeding on Probing (BoP);
Description
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).
Time Frame
T0: first session (for professional oral hygiene).
Title
Bleeding on Probing (BoP);
Description
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).
Time Frame
T1: second session, after 3 months (for domiciliary oral hygiene).
Title
Plaque Index on implant abutments
Description
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.
Time Frame
T0: first session (for professional oral hygiene).
Title
Plaque Index on implant abutments
Description
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.
Time Frame
T1: second session, after 3 months (for domiciliary oral hygiene).

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Armando Crupi, Dr.
Phone
+39 0116331531
Email
armando.crupi@unito.it
Facility Information:
Facility Name
S.C. Riabilitazione Orale Protesi Maxillo-Facciale e Implantologia Dentaria
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armando Crupi, Dr.
Phone
+39 0116331531
Email
armando.crupi@unito.it
First Name & Middle Initial & Last Name & Degree
Jacopo Lanzetti, Dr.
Phone
+39 0116331531
Email
jacopo.lanzetti@unito.it

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
18724855
Citation
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.
Results Reference
result
PubMed Identifier
24461161
Citation
Abi 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 Reference
result
PubMed Identifier
32348624
Citation
Mensi 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.
Results Reference
result

Learn more about this trial

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

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