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Orthodontic Anchorage ProceduresNCT02674191

Posterior Segment Intrusion Using Miniplates

A study testing mini-plates supported molar intrusion, Application of ULTRACARE benzocaine 20%, and Administration of , Mepivacaine-l in people with Orthodontic Anchorage Procedures, run by Manal El Namrawy.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Treating hyperdivergent malocclusion accompanied by open bite could be challenging and may be done by several methods as high pull headgear and posterior bite planes or surgically by maxillary impaction in adults. Read more about this study

Who is it for?
Ages 14 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Orthodontic Anchorage Procedures
What is being tested?
mini-plates supported molar intrusion, Application of ULTRACARE benzocaine 20%, and Administration of , Mepivacaine-l
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
May 2016to Jul 2018
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 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Mild to moderate skeletal Class II
  • Super eruption of maxillary posterior segment
  • Erupted full set of maxillary permanent teeth except 3rd molar
  • Increased lower facial height

Who cannot join

  • Previous orthodontic treatment
  • Any hormonal disorders or syndromes
  • Systemic Disease
  • Facial Asymmetry
  • Para-functional habits

About this study

Official title: Evaluation of Posterior Segment Intrusion Using Miniplates in Skeletal ClassII Hyperdivergent Adolescence: A Randomized Control Trial

Treating hyperdivergent malocclusion accompanied by open bite could be challenging and may be done by several methods as high pull headgear and posterior bite planes or surgically by maxillary impaction in adults. Nowadays it's the skeletal anchorage system (SAS) era as mini-screws and mini-plates ,hence we are aiming for absolute anchorage, and could minimize patient cooperation and the need for surgical treatment.

Read the detailed description

Interventions:

  1. Treatment group:

Medical History Questionnaire: will be filled by the patient to exclude the presence of any systemic condition.

Clinical Examination:

Oral structures will be examined by (M. N.) including Teeth for caries, fracture or missing teeth and gingival tissues for gingivitis, periodontitis, attachment loss, gingival recession, oral lesions and the nature of the gingival biotype.

The thorough intraoral examination is needed to evaluate the need for referral for consultation or intervention before the initiation of treatment.

Diagnosis: (M. B.) will check the patient to fulfill the previously mentioned inclusion criteria.

Full set of records will be taken for every patient as part of the routine procedure for treatment of patients in the outpatient clinic of the Orthodontic Department, Cairo University.

Clinical Procedures:

The clinical procedures are to be performed according to the protocol applied by Sherwood et al

  1. Patients will be referred for the uptake of a Cone Beam Computed Tomography (CBCT), which is considered as (T1). CBCT scanning will be performed with patients in maximum dental intercuspation with the next generation i-CAT CBCT unit according to the manufacture instructions. During scanning, the patient position will be standardized as follows; the Frankfort horizontal plane is parallel to the floor and mid sagittal plane is perpendicular to the Frankfort horizontal plane.
  2. Banding of the upper first molars will be done followed by taking an upper impression with the molar bands in place. A Transpalatal arch (TPA) will be fabricated from 0.9 mm wire and cemented in the upper arch. Bonding of the posterior segment with 3M brackets with MBT prescription 0.022" slot bracket system will be performed. Passive arch of 0.019×0.025" stainless steel arch wire will be placed in the posterior segment bilaterally
  3. Surgical procedures will be performed by (H. A.) and will include the following: Application of topical anesthesia, ULTRACARE benzocaine 20%, at the local anesthesia injection sites. Administration of local anesthesia, Mepivacaine-l. The injection will be infiltrated into the area where the miniplate will be fixed bilaterally. Proper disinfection will be performed with a local disinfectant, BETADINE povidone-iodine 10%, at the area. Surgery begins with a 1- to 2-cm vestibular incision and a full-thickness mucoperiosteal flap reflected to expose the cortical bone of the maxillary strut by blade no. 15 mounted on Bard Parker handle no.3. Two long Y or I shaped mini plates will be placed bilaterally at the zygomatic buttress area under local anesthesia. The mini plates will be adapted to fit the contour the underlying bone and adjusted to have their terminal part at the upper first molar area. Drilling is done using compatible sized drills mounted on low-speed air motor to create three holes at the sites of the mini screws that will be inserted for fixation of the mini plates. The mini plates will be fixed by three mini screws (diameter of 2 mm and 10 mm length) made of titanium. In case of loose mini screws upon tapping, emergency screws will be used instead of the loose ones (wider diameter so will enhance the interlocking with bone). After placement of the right and left miniplates, the flap was closed using black silk (3/0) continuous sutures leaving the extensions of the plates perforating the attached gingiva near the mucogingival junction. Postoperative instructions will be given to the patients, ice packs, a soft diet is advised. Postoperative antibiotic (150g Clindamycin/tds) for 1 week, as well as an analgesic (Cataflam 25mg), are prescribed post-operatively. Strict Oral hygiene instructions will be given to the patients and they will be recalled 1 week after the procedure to ensure adequate soft tissue healing. Sutures are removed one week after the surgery.
  4. Closed coil spring insertion: Loading of the mini plates was done three weeks after surgery to allow giving sufficient time for soft tissue healing. An intrusion force of (200-300) gm. produced by stretched closed coil spring will be applied and measured by a force gauge .
  5. Follow up period: The patient will be asked to attend follow-up visits every 4 weeks to check the following: by (M. B., F.H., and M. N.) The stability of the mini plates The integrity of the appliances The activity of the appliance The amount of correction achieved Any inflammation related to the appliance or the mini plates
  6. Appliance activation: The appliance will be activated every 4 weeks by (M. N.)
  7. The patients of both groups were asked to mark their degree of pain on a (VAS) visual analogue scale regarding their experience with the treatment phase.
  8. Termination and intervention: (The end point)
  • Reaching adequate overbite and inter-labial gap or 6 month from the start of intervention
  • Patient request
  • Poor oral hygiene
  • Abnormal side effects or severe inflammation
  1. Post-intrusion: A second records image will be ordered with the same criteria and parameters as previously mentioned. It is recorded as T2.
  2. Patients are going to continue treatment for existing malocclusion and for final detailing of occlusion

Criteria for modifying the allocated intervention:

In case of prolonged swelling and/or pain related to the mini plates, the patient might wait for more than three weeks before coil spring insertion.

In case of loose or broken mini plates, surgical intervention may be required for replacement of the mini plates and the treatment can be resumed after total resolution of the inflammation.

Adherence:

The patients will be asked to attend regular follow-up visits and their adherence to the appointments will be regularly monitored. Reminder calls or messages will be utilized to improve adherence. The patient adherence to intervention instructions will be monitored.

All the participants will be included in an intention to treat analysis, regardless of adherence.

  1. Control group:

The subjects should be fulfilling the previously mentioned inclusion criteria and should sign the informed consent of agreement to be recruited in the study.

According to the randomization sheet (done by E.M.), the patients allocated to the control group will be immediately referred for the uptake of a CBCT, which will be considered (T1) without any treatment procedures.

A "no treatment" phase of 6 months will be carried out through which the patients will be followed up to monitor any factor that might have occurred to exclude the patient from the study.

Another CBCT image will be taken after 6 months (T2), T2 images are to be considered the initial diagnostic images for the patient. The patients will then assessed and treatment will be provided for each patient as required.

Adherence:

The patients will be asked to attend regular follow-up visits in which full intra oral and extra oral examination will be performed (E.M.and M.N). Referral of the patient for restorative and/or periodontal therapy may be done with the needs of each case. The patients' adherence to the appointments will be regularly monitored. Reminder calls or messages will be utilized to improve adherence.

. Patients in the control group are going to start treatment for their existing malocclusion by (M. N)

Participant timeline:

The patients will be requested to visit the institutional clinic doing the required adjustments during the preparatory phase

The patients will then be scheduled to attend on the day of surgery, 1 week, 2 and 3 weeks after the surgery. They will also be requested for immediate show up in cases of emergency.

During posterior segment intrusion, the patients will be scheduled to attend every 3-4 weeks for appliance activation and monitoring the treatment progress.

The control group patients will be requested to visit the clinic every 4 weeks for follow up and improvement of the patients' adherence.

Being tested
mini-plates supported molar intrusion, Application of ULTRACARE benzocaine 20%,, Administration of , Mepivacaine-l, BETADINE povidone-iodine 10%, (150g Clindamycin/tds) for 1 week
Keywords
miniplates ,molar intrusion, hyperdivergent

What participants receive

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

  • mini-plates supported molar intrusionDevice

    (Stryker, Leibinger, GmbH\& Co., Freiburg, Germany) for molar intrusion using miniplates to treat hyperdivergent adolescence

  • Application of ULTRACARE benzocaine 20%,Procedure or surgery

    topical anesthesia (Ultradent Products, Inc)

  • Administration of , Mepivacaine-lProcedure or surgery

    local anesthesia

  • BETADINE povidone-iodine 10%Procedure or surgery

    a local disinfectant

  • (150g Clindamycin/tds) for 1 weekDrug

    Also called Dalacin

    Postoperative antibiotic

  • (Cataflam 25mg), are prescribed post-operativelyDrug

    Also called NSAIDs

    an analgesic

Study groups in NCT02674191
Study groupRoleWhat they receive
Group 1ExperimentalDevice: mini-plates supported molar intrusion (Stryker, Leibinger, GmbH\& Co., Freiburg, Germany) for molar intrusion using miniplates to treat hyperdivergent adolescence Procedure/Surgery: Application of ULTRACARE benzocaine 20%, topical anesthesia (Ultradent Products, Inc) Procedure/Surgery: Administration of , Mepivacaine-l local anesthesia Procedure/Surgery: BETADINE povidone-iodine 10% a local disinfectant Drug: (150g Clindamycin/tds) for 1 week Postoperative antibiotic Drug: (Cataflam 25mg), are prescribed post-operatively an analgesic
Receives: Device: mini-plates supported molar intrusion; Procedure: Application of ULTRACARE benzocaine 20%,; Procedure: Administration of , Mepivacaine-l; Procedure: BETADINE povidone-iodine 10%; Drug: (150g Clindamycin/tds) for 1 week; Drug: (Cataflam 25mg), are prescribed post-operatively
Group 2No interventionhyperdivergent adolescence with no intervention

What is being measured

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

  1. Lower facial height: the distance between soft tissue subnasale and gnathion (Sn.Gn) the difference will be measured in mm. before and after posterior segment intrusion

    This measurement relates principally to the vertical dimensions of the upper dento-alveolar process and the mandible.

    Measured: 6 months

Timeline

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

  1. First posted4 Feb 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionJun 2018 (estimated)
  4. Study completionJul 2018 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02674191
Sponsor's protocol ID
Jan 2016. Version 1
Status last verified
Feb 2018
First submitted
29 Jan 2016
Last updated
23 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kuroda S, Sakai Y, Tamamura N, Deguchi T, Takano-Yamamoto T. Treatment of severe anterior open bite with skeletal anchorage in adults: comparison with orthognathic surgery outcomes. Am J Orthod Dentofacial Orthop. 2007 Nov;132(5):599-605. doi: 10.1016/j.ajodo.2005.11.046.

    PubMed 18005833
  • Ng J, Major PW, Flores-Mir C. True molar intrusion attained during orthodontic treatment: a systematic review. Am J Orthod Dentofacial Orthop. 2006 Dec;130(6):709-14. doi: 10.1016/j.ajodo.2005.05.049.

    PubMed 17169732
  • Sherwood KH, Burch JG, Thompson WJ. Closing anterior open bites by intruding molars with titanium miniplate anchorage. Am J Orthod Dentofacial Orthop. 2002 Dec;122(6):593-600. doi: 10.1067/mod.2002.128641.

    PubMed 12490869
  • Greenlee GM, Huang GJ, Chen SS, Chen J, Koepsell T, Hujoel P. Stability of treatment for anterior open-bite malocclusion: a meta-analysis. Am J Orthod Dentofacial Orthop. 2011 Feb;139(2):154-69. doi: 10.1016/j.ajodo.2010.10.019.

    PubMed 21300243
  • Xun C, Zeng X, Wang X. Microscrew anchorage in skeletal anterior open-bite treatment. Angle Orthod. 2007 Jan;77(1):47-56. doi: 10.2319/010906-14R.1.

    PubMed 17029531

Questions about this trial

What is this clinical trial studying?

A study testing mini-plates supported molar intrusion, Application of ULTRACARE benzocaine 20%, and Administration of , Mepivacaine-l in people with Orthodontic Anchorage Procedures, run by Manal El Namrawy.

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 4 inclusion and 5 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 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lower facial height: the distance between soft tissue subnasale and gnathion (Sn.Gn) the difference will be measured in mm. before and after posterior segment intrusion (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02674191, which also lists 5 linked publications.

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 23 Feb 2018.

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