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Pocket DepthNCT02436525

Microbial and Periodontal Changes Associated With Conventional Versus Self Ligating Brackets

A study testing conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA), passive self-ligating stainless steel orthodontic brackets (Oromco - USA) and active self-ligating stainless steel orthodontic brackets (Oromco - USA) in people with Pocket Depth and Plaque Accumulation, run by Al-Azhar University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 18 yearsHealthy volunteers can take part
What is being tested?
conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA), passive self-ligating stainless steel orthodontic brackets (Oromco - USA) and active self-ligating stainless steel orthodontic brackets (Oromco - USA)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteEgypt
Study dates
Mar 2015to Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • Abnormal anteroposterior relationship or steep mandibular plane.
  • Crowding more than 6 mm.
  • Poor oral hygiene or periodontal affection.
  • Uncooperative patients.
  • Smoker patients.
  • Pregnant females.

Trial locations and contacts

1 site in 1 country.

Esam Al-hendi, Master student contact

00201158553005

esamdentist@yahoo.com

Egypt1 site, 1 recruiting
  • Faculty of Dentistry

    Cairo, Cairo Governorate

    Esam Alhendi, Master, 00201158553005, Esamdentist@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: Faculty of Dental Medicine, Boys, Cairo Al-Azhar University

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.

Read the 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.

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).

Patient's instructions:

Instructions form (a copy attached) will be signed by all patients and their parents before commencing the study.

Data management and analysis:BN All the obtained results will be gathered and statistically analyzed using Statistical Package for Social Sciences (SPSS, version 16, Inc., Chicago, Ill).

Being tested
conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA), passive self-ligating stainless steel orthodontic brackets (Oromco - USA), active self-ligating stainless steel orthodontic brackets (Oromco - USA)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA)Device

    Also called conb

  • passive self-ligating stainless steel orthodontic brackets (Oromco - USA)Device

    Also called pasb

  • active self-ligating stainless steel orthodontic brackets (Oromco - USA)Device

    Also called actb

Study groups in NCT02436525
Study groupRoleWhat they receive
Group I:Active comparatorwill be treated using conventional stainless steel orthodontic brackets ligated with stainless steel ligature. Oromco - USA. .
Receives: Device: conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA)
Group IIExperimental: will be treated using passive self-ligating stainless steel orthodontic brackets Oromco - USA.
Receives: Device: passive self-ligating stainless steel orthodontic brackets (Oromco - USA)
Group III:Experimentalwill be treated by active self-ligating stainless steel orthodontic brackets Oromco - USA .
Receives: Device: active self-ligating stainless steel orthodontic brackets (Oromco - USA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pocket depth

    Pocket depth measured by a Williams periodontal probe at baseline before treatment and at monthly interval for 6 months after bonding.

    Measured: every month for six months

  2. plaque accumulation

    plaque accumulation will be assess using Silness and Loe index

    Measured: every month for 6 months after bonding.

  3. Gingival bleeding

    Gingival bleeding will be evaluated by the presence or absence of bleeding on probing

    Measured: every month for 6 months after bonding.

  4. 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

    Measured: every month for 6 months after bonding.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionApr 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02436525
Sponsor's protocol ID
005OR.
Status last verified
Feb 2015
First submitted
19 Apr 2015
Last updated
6 May 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA), passive self-ligating stainless steel orthodontic brackets (Oromco - USA) and active self-ligating stainless steel orthodontic brackets (Oromco - USA) in people with Pocket Depth and Plaque Accumulation, run by Al-Azhar University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Esam Al-hendi, Master student (00201158553005, esamdentist@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pocket depth (time frame: every month for six months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.

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