Localized Piezoelectric Alveolar Decortication With Customized Orthodontic Treatment in Adults

NCT ID: NCT03406130

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-12-31

Brief 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

Tooth Overcrowding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Study Groups

Insignia orthodontic treatment

Group Type: ACTIVE_COMPARATOR

Orthodontic Procedure

Intervention Type: 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.

Piezocision-assisted Insignia orthodontic treatment

Group Type: EXPERIMENTAL

Orthodontic Procedure

Intervention Type: 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.

Piezocision surgery

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients requiring maxillary and mandible orthodontic treatment (both arches)
• Adult patients with completed growth based on the cervical vertebral maturation method as described by Baccetti et al. (Baccetti et al. 2002)
• Minimal to moderate maxillary and mandibular anterior crowding at baseline (irregularity index <6;(Little 1975));
• American Society of Anesthesiology I or II (I = nor- mal healthy patient; II = patient with mild systemic disease);
• Adequate dento-oral health (i.e., the absence of periodontal diseases, periapical infection, or untreated caries).

Exclusion Criteria

• controlled periodontitis with a loss of alveolar support >10%
• gingival recession >2 mm
• smokers
• altered bone metabolism (e.g., due to antiresorptive drug, steroid, or immunosuppressant use)
• mental or motor disabilities; and 6) pregnancy.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ACTEON Group

INDUSTRY

Sponsor Role: collaborator

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Dr. France LAMBERT

Prof. France Lambert

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Charavet C, Lecloux G, Jackers N, Maes N, Lambert F. Patient-reported outcomes measures (PROMs) following a piezocision-assisted versus conventional orthodontic treatments: a randomized controlled trial in adults. Clin Oral Investig. 2019 Dec;23(12):4355-4363. doi: 10.1007/s00784-019-02887-z. Epub 2019 Apr 6.

Reference Type: DERIVED

PMID: 30955096 (View on PubMed)

Charavet C, Lecloux G, Jackers N, Albert A, Lambert F. Piezocision-assisted orthodontic treatment using CAD/CAM customized orthodontic appliances: a randomized controlled trial in adults. Eur J Orthod. 2019 Sep 21;41(5):495-501. doi: 10.1093/ejo/cjy082.

Reference Type: DERIVED

PMID: 30649257 (View on PubMed)

Other Identifiers

P2016-1 WP1

Identifier Type: -

Identifier Source: org_study_id