Effect of Piezoelectric Alveolar Decortication on Post-Orthodontic Lower Incisors Stability: A Randomized Clinical Trial

• Sponsor: King Abdulaziz University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05014308
• Collaborator: (none)
• Enrollment: 39
• Arms: 3
• Actual Duration (Months): 41.7

Study Details

Study Description

Brief Summary

To assess the effect of piezocision on post-orthodontic lower anterior teeth stability as compared to fiberotomy and conventional Hawley retainers.

Condition or Disease	Intervention/Treatment	Phase
Retention	Procedure: Piezoelectric Alveolar Decortication, fibrotomy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Effect of Piezoelectric Alveolar Decortication on Post-Orthodontic Lower Incisors Stability: A Randomized Clinical Trial
• Actual Study Start Date: Mar 15, 2016
• Actual Primary Completion Date: Sep 5, 2019
• Actual Study Completion Date: Sep 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: piezocision group piezocision surgical procedure was done according to Dibart's et al,	Procedure: Piezoelectric Alveolar Decortication, fibrotomy
Experimental: fiberotomy group the fiberotomy procedure followed Edward's et al	Procedure: Piezoelectric Alveolar Decortication, fibrotomy
No Intervention: control group no intervention

Outcome Measures

Primary Outcome Measures

1. lower incisors stability after 6 months [6 months]

   study models will be evaluated 6 months after debonding Incisor Irregularity Index of lower anterior teeth will be measured using a digital caliper

2. lower incisors stability after 12 months [12 months]

   study models will be evaluated 12 months after debonding Incisor Irregularity Index of lower anterior teeth will be measured using a digital caliper

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Individuals who had lower anterior irregularity (crowding, rotation, buccally or lingually displaced) will be selected.

2. Good oral hygiene, healthy gingiva and no evidence of bone loss as seen on the radiograph.

3. Healthy systemic conditions.

4. Patients pass the growth spurt according to cervical vertebral maturation method as described by Baccetti et al.

5. Availability of good quality records at pretreatment and post-treatment.

Exclusion Criteria:

1. Patients that has any signs of active periodontal disease or evidence of bone loss on the radiograph.

2. Patients with systemic disease such as osteoporosis and diabetes.

3. Smoking patients.

4. Study casts did not include all mandibular permanent incisors, canines, and first molars.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• King Abdulaziz University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marwa Fahmy Saqat, master resident, King Abdulaziz University
• ClinicalTrials.gov Identifier: NCT05014308
• Other Study ID Numbers: 16011965
• First Posted: Aug 20, 2021
• Last Update Posted: Aug 20, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Marwa Fahmy Saqat, master resident, King Abdulaziz University: Retention; Relapse; Fibrotomy; Piezocision;

Study Results

No Results Posted as of Aug 20, 2021