Clinical trial NCT05965076: 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
Overall status: RECRUITING
Phase: NA
Conditions: Plaque, Dental
Keywords: glycine
airflow
full-arch
angled toothbrush
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Denture Plaque Index (DPI)
timeFrame: T0: first session (for professional oral hygiene).
measure: Denture Plaque Index (DPI)
timeFrame: T1: second session, after 3 months (for domiciliary oral hygiene).
Secondary outcomes:
measure: Probing Depth (PD);
timeFrame: T0: first session (for professional oral hygiene).
measure: Probing Depth (PD);
timeFrame: T1: second session, after 3 months (for domiciliary oral hygiene).
measure: Bleeding on Probing (BoP);
timeFrame: T0: first session (for professional oral hygiene).
measure: Bleeding on Probing (BoP);
timeFrame: T1: second session, after 3 months (for domiciliary oral hygiene).
measure: Plaque Index on implant abutments
timeFrame: T0: first session (for professional oral hygiene).
measure: Plaque Index on implant abutments
timeFrame: T1: second session, after 3 months (for domiciliary oral hygiene).
Other outcomes:
Locations:
city: Torino
country: Italy
facility: S.C. Riabilitazione Orale Protesi Maxillo-Facciale e Implantologia Dentaria
Study officials:
References:
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.
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.
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.