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

Plaque, Dental Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05965076
• Other study ID #: 99110619
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: September 15, 2024

Study information

• Verified date: July 2023
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: Armando Crupi, Dr.
• Phone: +39 0116331531
• Email: armando.crupi[@]unito.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: September 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Plaque
• Plaque, Dental

Intervention

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.

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.

Locations

Country	Name	City	State
Italy	S.C. Riabilitazione Orale Protesi Maxillo-Facciale e Implantologia Dentaria	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).