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A new study to minimise the side effects of rapid maxillary expansion

Evaluations of the effect of Zoledronic acid injection on dental and buccal alveolar bone changes following rapid maxillary expansion by using Cone Beam Computed Tomography (CBCT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16744226
Enrollment
34
Registered
2023-07-20
Start date
2021-01-01
Completion date
Unknown
Last updated
2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Side effects of rapid maxillary expansion (RME) on dental and buccal alveolar bone changes Oral Health

Interventions

The patients were distributed into two groups according to the manual random distribution method, whereby each patient who agreed to participate in the research was asked to withdraw a dark sealed env

Sponsors

Damascus University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Clinical maxillary transverse deficiency 2. Complete emergence of first molars and first premolars 3. Good oral hygiene

Exclusion criteria

Exclusion criteria: 1. Patients with medical situations or drug therapy that affected orthodontic treatment and periodontal health 2. Poor oral hygiene 3. Previous orthodontic treatment 4. Patient who didn’t correctly follow the protocol of activation or didn’t return for appointments

Design outcomes

Primary

MeasureTime frame
All measurements were carried out in a dark room then recorded and compared between baseline (T0) and 3 months (T1): 1. For the first molar on either side: The long axis (Y) in the sagittal plane was made parallel to the long axis of the mesiobuccal root. The X-axis was made tangent to the trifurcation. This process was also performed for the first molar on the other side. In the axial plane; the X-axis was positioned according to the buccolingual axis of the oval section of the mesiobuccal root and applied. Finally, in the coronal plane; the buccal surface of the root was made parallel to the tomographic vertical plane. The cementoenamel junction (CEJ) and the buccal alveolar crest were identified. Finally, readjustments were made if any change occurred. 2. The loss in buccal bone crest level (BBCL) was measured vertically from the CEJ to the alveolar crest. The buccal bone plate thickness (BBPT) was measured in two axial planes: the furcation plane and 3 mm above that plane, between buccal surfaces of the root and alveolar bone. 3. The same technique was followed to orient CBCT sections for the first premolar with its buccal root. The CEJ was set as a reference to identify two axial planes above it (3 mm and 6 mm) for BBPT because it was difficult to identify the furcation region of the first premolar. 4. The incidence of buccal dehiscence and fenestrations of the anchor teeth was reported. Dehiscence was defined as an increase in the distance between the CEJ and alveolar crest of more than 2 mm based on the normal value of alveolar height. Fenestrations were considered as alveolar bone discontinuation, which exposed a small region of the root and the defect didn’t involve the alveolar crest. If the image showed no cortical bone around the root in at least three sequential views, the defect was recorded as a dehiscence or a fenestration.

Secondary

MeasureTime frame
1. Questionnaires related to pain and discomfort were administered to patients in both groups at the same time of appliance installation. The questions were answered using a visual analog scale (VAS). The VAS consisted of a standard 10-mm metric ruler, where 0 corresponded to minor and 10 to greater levels of pain or discomfort. Patients were asked about the level of pain and discomfort immediately after zoledronic acid injection, 1 day after injection, 7 days after injection and 15 days after injection. 2. Patients were also questioned on the level of adaptation for speech, chewing and swallowing. The guardians’ perception of pain and discomfort caused by the therapy was also assessed. The same questionnaire was administered to the patients’ guardian 1 month after appliance placement in a separate environment. Parents/guardians were blinded to their child’s answers.

Countries

Syria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026