Trials / Completed
CompletedNCT03406130
Localized Piezoelectric Alveolar Decortication With Customized Orthodontic Treatment in Adults
Localized Piezoelectric Alveolar Decortication With Customized Orthodontic Treatment in Adults: A Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University of Liege · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
Summary
The aim of the present randomized controlled clinical trial will compare Insignia orthodontic treatment to piezocision-assisted Insignia orthodontics in adult patients. The primary objective will be to determine the efficacy of piezocision-accelerated orthodontic treatment by measuring the treatment duration in both groups. The secondary objectives will be to compare periodontal health, alveolar crest changes, bone and gingival healing, analgesic intake and patient-centered outcomes between the 2 groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Orthodontic Procedure | Damon self-ligating systems (Ormco) were used for all patients. The patients were allowed to choose between clear and metal brackets. The bonding method was standardized and applied according to the manufacturer's instructions. After bracket bonding, 0.014-in. copper nickel-titanium Damon arch forms were placed. The subjects returned every 2 wk, and the archwires were changed only when full bracket engagement were achieved. The sequence of archwires was the following: 0.018-in., 0.014 × 0.025-in., and 0.018 × 0.025-in. copper nickel-titanium archwires were used for alignment, while 0.019 × 0.025-in. stainless-steel archwires were used for fine-tuning. Following the alignment steps, impressions were taken, and a blinded senior orthodontist validated appliance removal or provided advice regarding further adjustments. Alginate impressions were taken after the removal of the appliances, and fixed and removable retainers were placed. |
| PROCEDURE | Piezocision surgery | The piezocision surgery was performed 1 week after orthodontic appliance placement. The surgical protocol was performed as described by Dibart and al. (Dibart et al. 2009). However, to avoid bias, hard and soft tissue augmentations were not considered. The patients received local anesthesia in both arches; vertical interproximal microincisions were created below each interdental papilla. In cases of root proximity (i.e., \<2 mm of interdental bone), this procedure was not performed. These incisions were kept to a minimum (varying from 5 to 8 mm). Next, with a vertical piezoelectric device, 5-mm-long and 3-mm-deep corticotomies were made, and no subsequent sutures were required. The patients were advised to take analgesics (paracetamol) only if necessary and to record their daily intake for 1 wk. Anti-inflammatories were prohibited to avoid interference with the RAP. |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2016-11-01
- Completion
- 2017-12-01
- First posted
- 2018-01-23
- Last updated
- 2018-01-23
Source: ClinicalTrials.gov record NCT03406130. Inclusion in this directory is not an endorsement.