Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery

NCT03967002 | Active Not Recruiting DMC

• 2 other identifiers: Study CORTICO2019-00160
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The use of corticotomy surgery in addition to orthodontic standard treatment could accelerate the treatment. Corticotomy involves vertical interdental incisions of the gingiva and the bone with a very low thickness. Orthodontic appliances are placed immediately after the surgery. This study aims to compare the tooth movement when correcting mandibular dental crowding in two groups of patients: Test group: orthodontic treatment and minimally invasive corticotomy surgery. Control group: standard orthodontic treatment without surgery.

Conditions

Dental Research; Orthodontics; Surgery, Oral; Maxillofacial Surgery; Tooth Disorder

Keywords

Accelerated orthodontics; Alveolar corticotomy; Piezoelectric surgery; Tooth movement; Dental crowding; Guided surgery; Minimally invasive oral surgery; Mandibular anterior alignment; Randomized prospective study

Outcome Measures

Primary Outcomes (1)

• Change from baseline tooth alignment at 12 months during the correction of the crowding in the anterior mandible.

  The linear displacement (canine-to-canine) in millimeter of the anatomic contact points of each incisor from the anatomic point of the adjacent teeth is measured (method of irregularity index scoring of Little) on dental impressions with an electronic calipers. Total alignment between 0 (total alignment) and 6 (no alignment).

  Baseline, 2 weeks, and 1, 2, 3, 4, 5, 6 and 12 months

Secondary Outcomes (7)

• Change from baseline plaque index at 12 months.

  Baseline, 6 and 12 months

• Change from baseline modified sulcus bleeding index at 12 months.

  Baseline, 6 and 12 months

• Change from baseline pocket probing depth at 12 months.

  Baseline, 6 and 12 months

• Change from baseline bone levels to 6 months.

  Baseline and 6 months

• Time-to-event of complications and adverse events

  Baseline, after surgery, after appliance of orthodontic material, 1 week, 2 weeks, and 1, 2, 3, 4, 5, 6 and 12 months

Study Arms (2)

Test group with corticotomy surgery

EXPERIMENTAL

Orthodontic treatment and minimally invasive corticotomy surgery with piezoelectric device and surgical guide

Procedure: Test group with corticotomy surgery

Control group without corticotomy surgery

NO INTERVENTION

Standard orthodontic treatment without surgery

Interventions

Test group with corticotomy surgery PROCEDURE

The surgery of corticotomy is performed with a piezo electric device and a personalized surgical guide just before the placement of orthodontic appliance. The initial impressions of the patient's dental arch as well as its three-dimensional radiography (CBCT) are used to create a perfectly adapted guide for minimally invasive corticotomy surgery. The incisions are made between the roots of: * the second premolars and first premolars, * the first lower premolars and canines, * the canines and lateral incisors, * the lateral incisors and central incisors, and, * the two lower central incisors.

Test group with corticotomy surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is over 18 years old,
• The dental crowding of the patient does not exceed 12 mm. The crowding, measured from the right mandibular canine to the left mandibular canine, doesn't require extraction or orthognathic surgery.
• The patient has no active periodontal disease and no history of treated periodontal disease.
• The patient has good dental hygiene.
• The patient has no untreated decay.
• The patient accepts the wear of metallic orthodontic materials.

You may not qualify if:

• The patient :
• is not able to understand the information given by the practitioner for legal, psychological or linguistic reasons.
• will have predictable follow-up difficulties.
• is pregnant.
• has a high risk of endocarditis.
• has severe or acquired immune deficiency.
• has a malignant condition, an history of radiotherapy in the mandibular region.
• has severe hematology, hemophilia, chronic renal failure, autoimmune disease, a condition requiring organ transplantation, poorly controlled diabetes, osteoporosis, rheumatoid arthritis or psychiatric illness.
• is under antimitotic, immunosuppressive or high dose corticosteroid treatment.
• smokes more than 10 cigarettes per day.
• has a systemic disease that affects bone, such as osteoporosis, hyperparathyroidism, or vitamin D deficiency.

Sponsors & Collaborators

• Ardentis Cliniques Dentaires: lead
• Centre Hospitalier Universitaire Vaudois: collaborator

Study Sites (1)

Ardentis Clinique Dentaire

Écublens, 1024, Switzerland

Location

MeSH Terms

Conditions

Tooth Diseases; Crowding

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Spatial Behavior; Behavior

Study Officials

• Marion Paris, DMD

  Oral surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 29, 2019
• Study Start: September 1, 2019
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

CH (1)