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

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.

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 Overview

• Status: Recruiting
• Conditions: Plaque, Dental
• Intervention / Treatment: Procedure: Standard Professional Oral Hygiene; Behavioral: Standard Domiciliary Oral Hygiene; Procedure: Glycine Perio Flow; Behavioral: Angled Toothbrush

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Armando Crupi, Dr.; Phone Number: +39 0116331531; Email: armando.crupi@unito.it

Study Locations

• Italy
  • Torino, Italy, 10126
    • Recruiting
    • S.C. Riabilitazione Orale Protesi Maxillo-Facciale e Implantologia Dentaria
    • Contact: Armando Crupi, Dr.; Phone Number: +39 0116331531; Email: armando.crupi@unito.it
    • Contact: Jacopo Lanzetti, Dr.; Phone Number: +39 0116331531; Email: jacopo.lanzetti@unito.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Estimated): May 15, 2024
• Study Completion (Estimated): September 15, 2024

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: full-arch; glycine; airflow; angled toothbrush
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Glycine Agents; Glycine
• Other Study ID Numbers: 99110619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No