Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Al-Azhar University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- plaque accumulation
Study Overview
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.
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 it's 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All patients should satisfy the following criteria:
- •Age ranged between 14-18 years.
- •All permanent teeth erupted (excluding third molars).
- •Angle Class I with normal facial proportion.
- •Moderate crowding (from 4 to 6 mm) or irregularity index greater than
- •All cases require treatment with fixed appliance with non extraction approach.
- •Good oral and general health.
- •No previous or current periodontal diseases.
- •No systemic disease or medication that may interfere with orthodontic teeth movement.
- •No history of trauma, bruxism or parafunction.
- •No previous orthodontic treatment.
Exclusion Criteria
- •Abnormal anteroposterior relationship or steep mandibular plane.
- •Crowding more than 6 mm.
- •Poor oral hygiene or periodontal affection.
- •Uncooperative patients.
- •Smoker patients.
- •Pregnant females.
Arms & Interventions
Group I:
will be treated using conventional stainless steel orthodontic brackets ligated with stainless steel ligature. Oromco - USA.
.
Intervention: conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA) (Device)
Group II
: will be treated using passive self-ligating stainless steel orthodontic brackets Oromco - USA.
Intervention: passive self-ligating stainless steel orthodontic brackets (Oromco - USA) (Device)
Group III:
will be treated by active self-ligating stainless steel orthodontic brackets Oromco - USA .
Intervention: active self-ligating stainless steel orthodontic brackets (Oromco - USA) (Device)
Outcomes
Primary Outcomes
plaque accumulation
Time Frame: every month for 6 months after bonding.
plaque accumulation will be assess using Silness and Loe index
Gingival bleeding
Time Frame: every month for 6 months after bonding.
Gingival bleeding will be evaluated by the presence or absence of bleeding on probing
Pocket depth
Time Frame: every month for six months
Pocket depth measured by a Williams periodontal probe at baseline before treatment and at monthly interval for 6 months after bonding.
Composite measure of Microbial parameters
Time Frame: every month for 6 months after bonding.
Plaque sample will be taken at base line and at monthly interval for six months after bonding Plaque sample will be send to laboratory for isolation of streptococcus mutans and lactobacilli. The isolated strains will be cultured and counted
Secondary Outcomes
No secondary outcomes reported
Investigators
Esam Al-hendi
Head of Dental department in Jepleh Hospital
Al-Azhar University