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

NCT05016713 | Unknown

• 1 other identifier: 8321
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

S.Mutans Colonization in Adults With Fixed Orthodontic Appliance

Keywords

streptococcus mutans; bacterial colonization; fixed appliance; plaque; oral hygiene; orthodontic appliance; adult

Outcome Measures

Primary Outcomes (1)

• Change in amount of Streptococcus mutans colonization

  Measure the difference in the amount of Streptococcus mutans colonization in adult patients with fixed orthodontic appliance with/without using chlorohexidine mouthwash. Samples will be collected at fixed timelines pre and during orthodontic treatment.

  T0: pre-bonding. T1: 1 month after bonding.

Secondary Outcomes (1)

• Change in plaque index score

  T0: pre-bonding. T1: 1 month after bonding.

Study Arms (3)

Intervention group 1

ACTIVE COMPARATOR

Fluoride-based toothpaste is used for tooth-brushing beside using interdental brushes.

Device: Interdental brush; Other: Fluoride-based toothpaste

Intervention group 2

ACTIVE COMPARATOR

Chlorhexidine mouthwash is added to the previous oral hygiene protocol being used beside fluoride-based toothpaste and interdental brushes. CHX mouthwash is used by patients according to the manufacturer's instructions 15 min after tooth-brushing: 5 mL of 0.2% CHX was applied for 60s in the morning and at bedtime. The patients will be instructed not to consume any liquid or food at least 30 min after using the prescribed mouthwash. All patients are asked to bring the mouthwash bottle, so we could determine patient compliance based on how much liquid was left.

Combination Product: Chlorhexidine mouthwash; Device: Interdental brush; Other: Fluoride-based toothpaste

Control group

PLACEBO COMPARATOR

Regular tooth-brushing is carried out using fluoride-based toothpaste supplied only.

Other: Fluoride-based toothpaste

Interventions

Chlorhexidine mouthwash COMBINATION_PRODUCT

Chlorhexidine mouthwash is added to the oral hygiene protocol being used beside fluoride-based toothpaste and interdental brushes. CHX mouthwash is used by patients according to the manufacturer's instructions 15 min after tooth-brushing: 5 mL of 0.2% CHX was applied for 60s in the morning and at bedtime. The patients will be instructed not to consume any liquid or food at least 30 min after using the prescribed mouthwash. All patients are asked to bring the mouthwash bottle, so we could determine patient compliance based on how much liquid was left. If any participant shows any signs of CHX hypersensitivity, the intervention will be discontinued.

Intervention group 2

Interdental brush DEVICE

Fluoride-based toothpaste is used for tooth-brushing beside using interdental brushes.

Intervention group 1; Intervention group 2

Fluoride-based toothpaste OTHER

Regular tooth-brushing is carried out using fluoride-based toothpaste supplied only.

Control group; Intervention group 1; Intervention group 2

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female adult patients with age range 18-30 years old.
• Good to fair oral hygiene indicated by healthy non-inflamed gingiva and absence of carious lesions at the time of recruitment.
• Full permanent dentition (except third molars).
• Mild to moderate crowding.
• Lack of using any mouth rinse for at least 1 month before the initiation of the study, and revealing no sign of sensitivity to mouthwashes.

You may not qualify if:

• Presence of any systemic or infectious diseases.
• History of antibiotic or hormonal therapy within the past 6 months prior to orthodontic treatment.
• History of smoking.
• History of professional cleaning (scaling) within the past 3 days prior to sample collection.
• Presence of major untreated dental conditions such as untreated carious lesions at baseline.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of oral & dental medicine Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Plaque, Amyloid

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mohamed Abdelsalam Elbanna, MSc

CONTACT

+201284983173; mohamed_abdelsalam@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding of the operator: Blinding will not be possible for the operator during the application interventions and during the follow up visits as he will be responsible for recruitment of sample, giving instruction about different hygiene measures that will be used by intervention/control group and follow up of patients collecting samples for that will be used in analysis. Blinding of the outcome assessors: It is a single blinded study, the outcome assessors only will be blind. The patients name will be sealed from pre and post samples. Then assessor will carry on, blindly and independently, the measurements and analysis of the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master candidate

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 23, 2021
• Study Start: June 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2024
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

EG (1)