Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02674191 |
| Other study ID # |
Jan 2016. Version 1 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
January 29, 2016 |
| Last updated |
February 21, 2018 |
| Start date |
May 2016 |
| Est. completion date |
July 2018 |
Study information
| Verified date |
February 2018 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
Description:
Interventions:
A. 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
9. Post-intrusion:
A second records image will be ordered with the same criteria and parameters as
previously mentioned. It is recorded as T2.
10. 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.
B. 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.
