Class II Div 1 Malocclusion Clinical Trial
Official title:
An Evaluation of the Efficacy of Conventional Corticotomy Versus Flapless Corticotomy in the En-Masse Retraction of Upper Anterior Teeth : A Randomized Controlled Trial
This study aims to evaluate and compare the skeletal, dental and soft tissue changes, the
levels of pain and discomfort and the effect on periodontal health and teeth vitality
associated to traditional corticotomy and flapless corticotomy in the retraction of upper
anterior teeth.
40 patients requiring extraction of maxillary first premolars and maximum anchorage to
retract the upper anterior teeth will participate in the study. They will be divided randomly
into two groups : flapless corticotomy (20 patients) and traditional corticotomy (20
patients). Pre-retraction, corticotomy will be performed in the maxillary anterior segment.
The skeletal, dental and soft tissue changes will be performed using lateral cephalometric
radiographs which will be obtained pretreatment, pre and post en-masse retraction of the
anterior teeth and we will also use the dental casts to evaluate the dental changes.
A corticotomy is cutting of the bone involves cortical bone only, leaving intact the
medullary vessels and periosteum It offers an advantage to adult patients in reduction the
orthodontic treatment time. The definition of traditional corticotomy is: elevating
full-thickness periodontal flaps from a coronal approach, and vertical corticotomies are made
between the teeth extending from 2-3 mm apical of the alveolar crest to 2 mm beyond the tooth
apices and connected by a horizontal corticotomy; this process is done on both the labial and
palatal aspects.
The definition of flapless corticotomy is: a minimally invasive version of corticotomy, using
a piezotome in order to inflict bone injury. This technique entails labial and palatal
interproximal piezoelectric microincisions into the cortical bone, without reflecting
periodontal flaps.
Prior to enrollment of each subject into the study, they will be examined completely to
determine the orthodontic treatment plan. The operator will inform them about the aim of the
study and ask them to provide a written informed consent.
Self-drilling titanium mini-implants (1.6mm diameter and 8mm length) will be used. they will
be inserted between the maxillary second premolar and first molar at approximately 8-10mm
above the archwires at the mucogingival junction and will be checked for primary stability
(mechanical retention). Then the maxillary first premolar will be extracted. The maxillary
arch will be levelled and aligned. The rectangular stainless steel archwires (0.019" ×
0.025") with anterior 8mm height soldered hooks distal to the lateral incisors will be
inserted.
The surgery will be carried out under local anesthesia. The traditional corticotomy will be
handled by the same maxillofacial surgeon and the flapless corticotomy will be handled by the
same orthodontist.
For traditional corticotomy, sulcular incisions the mesial aspect of one second premolar to
the mesial surface of the contralateral second premolar will be placed, and full thickness
flap will be elevated, 3 mm above the apical region of the tooth. piezoelectric under copious
irrigation will be used for making vertical and horizontal cuts (only cortical surface). The
vertical cuts will be between the dental roots in the interdental cortical surfaces ,stopping
2 mm short of the alveolar crest, occlusally. Horizontal cut will connect the vertical cuts 2
mm beyond root apex. These cuts will be performed from the mesial aspect of one second
premolar to the mesial surface of the contralateral second premolar involving the anteriors.
Similarly, a palatal flap incision will be raised immediately for doing the same vertical and
horizontal cuts in the superficial surface of the palatal bone.
For the flapless corticotomy, The depth of gingival tissue will be determined through bone
sounding using a periodontal probe. A scalpel will be used to make the incisions through the
gingiva, 4mm below the interdental papilla to preserve the coronal attached gingiva. These
vertical incisions will be placed from the mesial aspect of one second premolar to the mesial
surface of the contralateral second premolar on the labial and palatal aspects of the maxilla
through the gingiva and the underlying bone. A piezosurgery knife will be used to create the
cortical alveolar incisions to a depth of 1 mm within the cortical bone.
Postoperatively, all patients will be advised to rinse with chlorhexidine mouthwash twice a
day for one week. All patients will be contacted the day after the procedure to ensure no
complications with surgery and will be followed up one month post-surgery to assess for signs
of infection and ensure normal healing. We will assess patients' acceptance and the levels of
pain and discomfort of traditional corticotomy and flapless corticotomy by asking all
patients to fill out 4 questionnaires during the first month after the surgical procedure
using a VAS.
The surgical procedure will be performed and (250-300) g force will be applied on each side
(3-4 days) after corticotomy using two NiTi springs attached between the mini-implants and
the soldered hooks in a direction approximately parallel to the occlusal plane for conducting
an en-masse retraction. The force level will be measured every 2 weeks after the corticotomy
. Retraction will be stopped when a class I canine relationship will be achieved and a good
incisor relationship will be obtained.
Periodontal health will be assessed at the beginning of orthodontic treatment, before and
after corticotomy by evaluating the following parameters: plaque index, gingival index,
bleeding index, and gingival recession.
Dental casts will be used for the quantification of the anteroposterior movement of the
anterior teeth and the first molars every 30 days until class I canine relationship will be
achieved and a good incisor relationship will be obtained.
To evaluate the movement of the anterior teeth: we will project the canine cusp on the median
line and measure the distance from this point to the projected position of a distinct medial
ruga point.
To evaluate the movement of the first molars: we will project the mesial contact point of the
first molar on the median line and measure the distance from this point to the projected
position of a distinct medial ruga point. These measurements will be made with sliding
calipers.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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N/A | |
| Recruiting |
NCT05639725 -
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N/A |