NCT05016713

Changes in Streptococcus Mutans Colonization With Different Oral Hygiene Protocols in Adult Patients With Fixed Orthodontic Appliance

Status unknown NA Last updated 9 February 2023

What this trial tests

NA trial testing Chlorhexidine mouthwash in S.Mutans Colonization in Adults With Fixed Orthodontic Appliance in 27 participants. Status unknown.

Timeline

1 June 2021

Primary endpoint
1 July 2023

1 August 2024

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	27
Start date	1 June 2021
Primary completion	1 July 2023
Estimated completion	1 August 2024
Sites	1 location across Egypt

Drugs / interventions tested

• Chlorhexidine mouthwash — full drug profile →
• Interdental brush
• Fluoride-based toothpaste

Conditions studied

• S.Mutans Colonization in Adults With Fixed Orthodontic Appliance — all drugs for S.Mutans Colonization in Adults With Fixed Orthodontic Appliance →

Sponsor

Cairo University

Who can join

Adults 18 to 30, any sex, with S.Mutans Colonization in Adults With Fixed Orthodontic Appliance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Fixed orthodontic appliances increase the rate of plaque accumulation around orthodontic brackets and gingival margins. It was also found that the amount of plaque accumulation and S.mutans level around banded orthodontic appliances is much higher than unbanded appliances.appliances. This increases the importance of regular use of conventional tooth brushing with or without mouthwash for better control of plaque accumulation. Different studies had been conducted to compare the effect of different mouthwashes on plaque accumulation and rate of different bacterial colonization. Among which is Chlorhexidine mouthwash that showed highest antiseptic effect.

S. mutans bacteria are the main reason for the formation of plaque and dental caries associated with the use of fixed braces in 30-70% of patients. It also causes the appearance of white spot lesions on the teeth during and after fixed orthodontic treatment. Therefore, it is necessary to find solutions to overcome the occurrence of these effects resulting from the use of fixed braces, which usually makes it difficult for the accessing of various cleaning tools to these narrow places around the orthodontic brackets. Therefore, it is necessary to find an effective and easy way to clean the teeth that guarantees the safety of the patient's teeth during and after orthodontic treatment.Although mechanical plaque removal is very effective way in controlling amount of plaque accumulation, it is not applicable for subsequent application in patients with fixed orthodontic appliance.

Streptococcus mutans is considered as the main colonizer in the multi-species plaque biofilm. Studies found that as early as one week after bonding of fixed orthodontic appliances, significant changes occurred in the oral microbiota forming microbial plaque at the metal surfaces and the adjacent tooth surface.

The aim of this study is to compare the effect of three different oral hygiene protocols on the amount of Streptococcus mutans colonization in adult patients with fixed orthodontic appliance.

The null hypothesis is that there is no difference on the amount of Streptococcus mutans colonization between using combined tooth brushing, interdental brushing and mouthwash than using tooth brushing and interdental brushing in comparison to tooth brushing alone in adult patients with fixed orthodontic appliance.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. IgYs: on her majesty's secret service.
   Grzywa R, Łupicka-Słowik A, Sieńczyk M. · · 2023 · cited 11× · PMID 37377972 · DOI 10.3389/fimmu.2023.1199427
2. WHICH ORAL HYGIENE PROTOCOL SHOULD BE FOLLOWED BY PATIENTS WITH FIXED ORTHODONTIC APPLIANCES? A RANDOMIZED CLINICAL TRIAL.
   Elbanna MA, Elbanna SA, Abdelsayed F, Abd-El-Ghafour M. · · 2025 · PMID 41290275 · DOI 10.1016/j.jebdp.2025.102192