Microbial and Periodontal Changes Associated With Conventional Versus Self Ligating Brackets
Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 19, 2015
CompletedFirst Posted
Study publicly available on registry
May 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedMay 6, 2015
February 1, 2015
1.1 years
April 19, 2015
May 5, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Pocket depth
Pocket depth measured by a Williams periodontal probe at baseline before treatment and at monthly interval for 6 months after bonding.
every month for six months
plaque accumulation
plaque accumulation will be assess using Silness and Loe index
every month for 6 months after bonding.
Gingival bleeding
Gingival bleeding will be evaluated by the presence or absence of bleeding on probing
every month for 6 months after bonding.
Composite measure of Microbial parameters
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
every month for 6 months after bonding.
Study Arms (3)
Group I:
ACTIVE COMPARATORwill be treated using conventional stainless steel orthodontic brackets ligated with stainless steel ligature. Oromco - USA. .
Group II
EXPERIMENTAL: will be treated using passive self-ligating stainless steel orthodontic brackets Oromco - USA.
Group III:
EXPERIMENTALwill be treated by active self-ligating stainless steel orthodontic brackets Oromco - USA .
Interventions
Eligibility Criteria
You may qualify if:
- 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 4.
- 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.
You may not qualify if:
- Abnormal anteroposterior relationship or steep mandibular plane.
- Crowding more than 6 mm.
- Poor oral hygiene or periodontal affection.
- Uncooperative patients.
- Smoker patients.
- Pregnant females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry
Cairo, Cairo Governorate, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Dental department in Jepleh Hospital
Study Record Dates
First Submitted
April 19, 2015
First Posted
May 6, 2015
Study Start
March 1, 2015
Primary Completion
April 1, 2016
Last Updated
May 6, 2015
Record last verified: 2015-02