Orthodontic Appliance Complication Clinical Trial
— [PLD]Official title:
Evaluation of Periodontal Ligament Distraction Using a Modified Surgical Technique for Retraction of Maxillary Canines in Adult Patients (Split-mouth Randomized Clinical Trial)
| NCT number | NCT03535285 |
| Other study ID # | 11111 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 15, 2017 |
| Est. completion date | December 15, 2017 |
| Verified date | May 2018 |
| Source | Cairo University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Surgical modification technique try to get bodily movement during upper canine retraction.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | December 15, 2017 |
| Est. primary completion date | August 15, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 25 Years |
| Eligibility |
Inclusion Criteria: 1. Orthodontic patients needed extraction of upper first premolars, with age range from 18 - 25 years old. 2. All patients were medically free. (See Appendix II) 3. No previous orthodontic treatment. 4. Adequate oral hygiene and periodontally healthy teeth. 5. The canines were almost leveled and aligned. 6. Maximum anchorage requirements. 7. Healthy canines; no deep carious lesions, no endodontic lesions, no root canal treatment, nor internal or external root resorption. 8. All patients were informed of the procedure and signed the consents. Exclusion Criteria: Exclusion Criteria Subjects were excluded from the study when: 1. They failed to keep several consecutive appointments. 2. Oral hygiene was subjectively judged as deteriorating during the preliminary stages of patient preparation. 3. Compliance with the instructions provided was inadequate. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Cairo University - Orthodontic department | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Cairo University |
Egypt,
Liou EJ, Huang CS. Rapid canine retraction through distraction of the periodontal ligament. Am J Orthod Dentofacial Orthop. 1998 Oct;114(4):372-82. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tipping of the canines | Periapical radiograph using Parallel technique (X-ray sensor , X-ray sensor holder & Potable dental x-ray unit Panoramic radiograph . |
3-4 weeks | |
| Primary | Rate of canines retraction | Digital models using 3shape scanner and Ortho-Analyzer software | 3-4 weeks | |
| Primary | Rotation of the canines | Digital models using 3shape scanner and Ortho-Analyzer software | 3-4 weeks | |
| Secondary | Amount of anchorage loss | Digital models using 3shape scanner and Ortho-Analyzer software | 3-4 weeks | |
| Secondary | Tipping of the molars | Periapical radiograph using Parallel technique (X-ray sensor , X-ray sensor holder & Potable dental x-ray unit Panoramic radiograph. |
3-4 weeks | |
| Secondary | The apical root resorption scores | Periapical radiograph using Parallel technique (x-ray sensor, X-ray sensor holder & Potable dental x-ray unit | 3-4 weeks | |
| Secondary | Pulp Vitality | Cold application (Ethyl Chloride) | 3-4 weeks | |
| Secondary | Gingival index | Periodontal probe | 3-4 weeks | |
| Secondary | Periodontal index | Periodontal probe | 3-4 weeks | |
| Secondary | Pain | Numeric rating scale (NRS) for pain | 3-4 weeks |
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