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

NCT05965076 | Recruiting

• 1 other identifier: 99110619
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque, Dental

Keywords

glycine; airflow; full-arch; angled toothbrush

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Probing Depth (PD);

  T0: first session (for professional oral hygiene).

• Probing Depth (PD);

  T1: second session, after 3 months (for domiciliary oral hygiene).

• Bleeding on Probing (BoP);

  T0: first session (for professional oral hygiene).

• Bleeding on Probing (BoP);

  T1: second session, after 3 months (for domiciliary oral hygiene).

• Plaque Index on implant abutments

  T0: first session (for professional oral hygiene).

Study Arms (4)

Standard

ACTIVE COMPARATOR

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; Behavioral: Standard Domiciliary Oral Hygiene

Glycine

EXPERIMENTAL

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; Behavioral: Standard Domiciliary Oral Hygiene

Angled toothbrush

EXPERIMENTAL

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; Procedure: Standard Professional Oral Hygiene

Glycine - Angled toothbrush

EXPERIMENTAL

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; Behavioral: Angled Toothbrush

Interventions

Glycine Perio Flow PROCEDURE

Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss and glycine perio-flow.

Glycine; Glycine - Angled toothbrush

Angled Toothbrush BEHAVIORAL

Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and an angled toothbrush.

Angled toothbrush; Glycine - Angled toothbrush

Standard Professional Oral Hygiene PROCEDURE

Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss.

Angled toothbrush; Standard

Standard Domiciliary Oral Hygiene BEHAVIORAL

Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and a standard toothbrush.

Glycine; Standard

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18years
• Good systemic health, with ASA classification \<= 2
• Columbus Bridge ProtocolTM reinstation from at least six months

You may not qualify if:

• 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

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (1)

S.C. Riabilitazione Orale Protesi Maxillo-Facciale e Implantologia Dentaria

Torino, 10126, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 18724855 RESULT

• 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.

  PMID: 24461161 RESULT

• 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.

  PMID: 32348624 RESULT

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Armando Crupi, Dr.

CONTACT

+39 0116331531; armando.crupi@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 28, 2023
• Study Start: February 6, 2023
• Primary Completion: October 15, 2024
• Study Completion: December 15, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)