Ignite Creation Date:
2024-05-06 @ 4:01 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02436525
Status:
UNKNOWN
Last Update Posted:
2015-05-06
First Post:
2015-04-19
Brief Title:
Microbial and Periodontal Changes Associated With Conventional Versus Self Ligating Brackets
Sponsor:
Al-Azhar University
Organization:
Al-Azhar University
Study Overview
Official Title:
Faculty of Dental Medicine Boys Cairo Al-Azhar University
Status:
UNKNOWN
Status Verified Date:
2015-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Microbial and periodontal changes associated with conventional versus self ligating brackets
The aim of this study will be to compare microbial and periodontal changes associated with conventional versus self ligating brackets
The aim of this study will be to compare microbial and periodontal changes associated with conventional versus self ligating brackets
Detailed Description:
Microbial and periodontal changes associated with conventional versus self ligating brackets
Protocol submitted in partial fulfillment for the requirements of Master Degree in Orthodontics
Accumulation of biofilm on the tooth surfaces is associated with increased levels of oral streptococcus mutans and lactobacilli which have been proved to be responsible for the onset of enamel demineralization and periodontal disease
It has been shown that fixed appliance provides large number of retentive areas for plaque accumulation and impedes oral hygiene
Three methods are currently used to connect the arch wire to the brackets which are ligation with stainless steel ligatures using elastomeric ligatures and the self-ligating brackets Each of these method has its advantages and disadvantages concerning the biofilm retention and the level of microorganisms Orthodontic treatment with conventional brackets my presents some periodontal changes caused by difficulty in oral hygiene maintenance greater accumulation and qualitative alteration of plaque Thus in order to control oral hygiene and plaque level during fixed appliance therapy manufacturers introduced self-ligating brackets SLBs which have been claimed to provide better oral hygiene and less plaque accumulation because of fewer retentive sites for microbial colonization without the need for stainless steel and elastomeric ligature Clinically the side effects of fixed orthodontic treatment such as the qualitative bacterial shift are manifested as plaque associated gingivitis an increase in pocket probing depth PPD and bleeding on probing
Fewer studies have compared conventional and self-ligating brackets in relation to oral hygiene microbial count and periodontal indices Therefore the present study will be conducted to evaluate and compare microbial and periodontal changes with conventional and self ligating brackets
The aim of this study will be to compare microbial and periodontal changes associated with conventional versus self ligating brackets
Subjects and method
Study design
Randomized controlled clinical trial
Study setting and population
The sample of this study will be consisted of forty five patients selected from Outpatient Clinic Orthodontic Department Faculty of Dental Medicine Boys Cairo Al-Azhar University
Interventions
The patients will be divided randomly into three groups and will be treated separately as follows
Group I will be treated using conventional stainless steel orthodontic brackets ligated with stainless steel ligature
Group II will be treated using passive self-ligating stainless steel orthodontic brackets
Group III will be treated by active self-ligating stainless steel orthodontic brackets
Records
For all patients the following records will be taken before and after treatment
1 Standardized Orthodontic study cast
2 Standardized intra oral and extra oral photographs
3 Standardized panoramic radiograph
4 Standardized lateral cephalometric radiograph
Observations
Periodontal parameters The following clinical parameters will be recorded at baseline before treatment and at monthly interval for 6 months after bonding
1 Pocket probing depth
2 Plaque index Silness and Loe
3 The presence or absence of bleeding on probing
Microbial parameters
Plaque sample will be taken at base line and at monthly interval for six months after bonding The sample will be taken from the maxillary left canine second premolar and the right central incisor and the mandibular right canine second premolar and the left central incisor
Plaque sample will be send to laboratory for isolation of streptococcus mutans and lactobacilli The isolated strains will be cultured and counted
Ethical consideration
All patients will clearly understand the purpose of the study and give their consent by signing an informed consent attached copy of the consent form
Patients instructions
Instructions form a copy attached will be signed by all patients and their parents before commencing the study
Data management and analysisBN All the obtained results will be gathered and statistically analyzed using Statistical Package for Social Sciences SPSS version 16 Inc Chicago Ill
Protocol submitted in partial fulfillment for the requirements of Master Degree in Orthodontics
Accumulation of biofilm on the tooth surfaces is associated with increased levels of oral streptococcus mutans and lactobacilli which have been proved to be responsible for the onset of enamel demineralization and periodontal disease
It has been shown that fixed appliance provides large number of retentive areas for plaque accumulation and impedes oral hygiene
Three methods are currently used to connect the arch wire to the brackets which are ligation with stainless steel ligatures using elastomeric ligatures and the self-ligating brackets Each of these method has its advantages and disadvantages concerning the biofilm retention and the level of microorganisms Orthodontic treatment with conventional brackets my presents some periodontal changes caused by difficulty in oral hygiene maintenance greater accumulation and qualitative alteration of plaque Thus in order to control oral hygiene and plaque level during fixed appliance therapy manufacturers introduced self-ligating brackets SLBs which have been claimed to provide better oral hygiene and less plaque accumulation because of fewer retentive sites for microbial colonization without the need for stainless steel and elastomeric ligature Clinically the side effects of fixed orthodontic treatment such as the qualitative bacterial shift are manifested as plaque associated gingivitis an increase in pocket probing depth PPD and bleeding on probing
Fewer studies have compared conventional and self-ligating brackets in relation to oral hygiene microbial count and periodontal indices Therefore the present study will be conducted to evaluate and compare microbial and periodontal changes with conventional and self ligating brackets
The aim of this study will be to compare microbial and periodontal changes associated with conventional versus self ligating brackets
Subjects and method
Study design
Randomized controlled clinical trial
Study setting and population
The sample of this study will be consisted of forty five patients selected from Outpatient Clinic Orthodontic Department Faculty of Dental Medicine Boys Cairo Al-Azhar University
Interventions
The patients will be divided randomly into three groups and will be treated separately as follows
Group I will be treated using conventional stainless steel orthodontic brackets ligated with stainless steel ligature
Group II will be treated using passive self-ligating stainless steel orthodontic brackets
Group III will be treated by active self-ligating stainless steel orthodontic brackets
Records
For all patients the following records will be taken before and after treatment
1 Standardized Orthodontic study cast
2 Standardized intra oral and extra oral photographs
3 Standardized panoramic radiograph
4 Standardized lateral cephalometric radiograph
Observations
Periodontal parameters The following clinical parameters will be recorded at baseline before treatment and at monthly interval for 6 months after bonding
1 Pocket probing depth
2 Plaque index Silness and Loe
3 The presence or absence of bleeding on probing
Microbial parameters
Plaque sample will be taken at base line and at monthly interval for six months after bonding The sample will be taken from the maxillary left canine second premolar and the right central incisor and the mandibular right canine second premolar and the left central incisor
Plaque sample will be send to laboratory for isolation of streptococcus mutans and lactobacilli The isolated strains will be cultured and counted
Ethical consideration
All patients will clearly understand the purpose of the study and give their consent by signing an informed consent attached copy of the consent form
Patients instructions
Instructions form a copy attached will be signed by all patients and their parents before commencing the study
Data management and analysisBN All the obtained results will be gathered and statistically analyzed using Statistical Package for Social Sciences SPSS version 16 Inc Chicago Ill
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None