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Active, not recruitingNCT03967002CORTICOUpdated Nov 4, 2026

Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery

An interventional study of Test group with corticotomy surgery in Dental Research, Orthodontics and Surgery, Oral, sponsored by Ardentis Cliniques Dentaires. Active, not recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Ardentis Cliniques Dentaires · Not applicable, Interventional, and Treatment

Updated Nov 4, 20261 site added1 site removedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Dental crowding in children, adolescents or adults is the most common reason to undergo orthodontic treatment. This malocclusion, characterized by the overlapping of teeth, is caused by a lack of space. In the mandibular anterior region, it is a predisposing factor for a periodontal disease. Good oral hygiene is difficult to maintain because the dental crowding promotes plaque retention in narrow interdental spaces and complicates the passage of brushes and dental floss. The standard orthodontic treatment lasts approximately 18-30 months. If the mandibular tooth space is less than 6 mm, it can be generally treated by orthodontics without therapeutic extractions.

Corticotomy has been a proven surgical technique for many years. It involves vertical interdental incisions of the gingiva and the bone with a very low thickness. It is mainly used to facilitate the movements of teeth. Dental movements associated with corticotomy may be twice as fast as those achieved with standard non-surgical treatment.

The study focuses on the correction of mandibular dental crowding. Its purpose is to compare the tooth movement obtained with orthodontic treatment and minimally invasive corticotomy surgery with that obtained with standard orthodontic treatment without surgery.

Patients requesting an orthodontic treatment to correct a dental crowding less than 12 mm are randomized to benefit from corticotomy surgery and orthodontic treatment (test group) or from only orthodontic treatment (control group). It is planned the inclusion of 22 patients, 11 in the test group and 11 in the control group.

After two visits necessary for the recruitment phase, treatment starts for the test group with the surgery and the appliance with brackets and arches, and, for the control group, with the appliance with brackets and arches.

The surgery of corticotomy is performed with 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) make it possible to create a perfectly adapted guide. The incisions are made with a piezoelectric device between the roots of teeth, from the mandibular second premolar to the contralateral second mandibular premolar.

The study lasts 12 months after the placement of orthodontic material. During this 12 months, periodical controls (1 week, 2 weeks and 1-12 months) are carried out. After these 12 months, all patients undergo treatment with controls specific to standard orthodontic procedure.

02

Conditions studied

  • 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
03

In context

Tooth Diseases

79 studies on the registry are indexed under Tooth Diseases; 11 are open to participants now.

This study's planned enrollment of 22 is below the median of 49 across 63 interventional studies indexed under Tooth Diseases.

Browse Tooth Diseases studies →

Lead sponsor

This is the only study on the registry with Ardentis Cliniques Dentaires as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

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, disease, a condition requiring organ transplantation, poorly controlled diabetes, osteoporosis, rheumatoid arthritis or psychiatric illness.
  • is under antimitotic, or high dose treatment.
  • smokes more than 10 cigarettes per day.
  • has a systemic disease that affects bone, such as osteoporosis, hyperparathyroidism, or vitamin D deficiency.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • Experimental
    Test group with corticotomy surgery

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

    Procedure: Test group with corticotomy surgery

  • No intervention
    Control group without corticotomy surgery

    Standard orthodontic treatment without surgery

Interventions

  • ProcedureTest group with corticotomy surgery

    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.

06

What researchers measure

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).

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

Secondary outcomes

  1. Change from baseline plaque index at 12 months.

    The plaque index is scored using a periodontal probe at four sites around each tooth (mesial, distal, vestibular, palatal sides) and the average value is calculated. The range of the score is 0 to 3: score 0: No plaque; score 1: Plaque revealed with the use of probe on the tooth surface. Thin film of plaque. score 2: Plaque observed with naked eye. Moderate accumulation of soft deposit. score 3: Abundance of soft matter. Large amount of plaque.

    Time frame: Baseline, 6 and 12 months

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

    The modified sulcus bleeding index is scored using a periodontal probe at four sites around each tooth (mesial, distal, vestibular, palatal sides) and the average value is calculated. The range of the score is 0 to 3: score 0: No bleeding when a periodontal probe is passed along the gingival margin adjacent to the tooth; score 1: Isolated bleeding; score 2: Blood forms a confluent red line on margin; score 3: Heavy or profuse bleeding.

    Time frame: Baseline, 6 and 12 months

  3. Change from baseline pocket probing depth at 12 months.

    The pocket probing depth measurement in millimeter is performed from the gingival margin to the epithelial attachment using a periodontal probe at four sites around each tooth (mesial, distal, vestibular, palatal sides) and the average value is calculated. It was classified as: no/mild pocket depth ≤3 mm, moderate pocket depth 4-5 mm, severe pocket depth ≥6 mm.

    Time frame: Baseline, 6 and 12 months

  4. Change from baseline bone levels to 6 months.

    Measurement of height and thickness of the alveolar bone in millimeter using cone-beam computerized tomography (CBCT).

    Time frame: Baseline and 6 months

  5. Time-to-event of complications and adverse events

    The number and nature of complications and adverse events will be recorded at each visit and compared between interventional and control groups.

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

  6. Pain intensity measures: analog visual scale

    Self reported pain intensity at each visit. It is scored 0-10 with an analog visual scale. The score is determined by measuring the distance in centimeter on the 10-cm line between the "no pain" anchor (score 0) and the patient's mark, providing a range of scores from 0-10. The maximum of pain is scored 10. The mean of pain intensities of all patients at each control will be classified according to the following cut points: 0-0.4 cm: no pain, 0.5-4.4 cm: mild pain, 4.5-7.4 cm: moderate pain, and 7.5-10 cm: severe pain.

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

  7. Satisfaction measures: analog visual scale

    Self reported satisfaction towards the treatment at the end of the treatment. It is scored 0-10 with an analog visual scale. The score is determined by measuring the distance in centimeter on the 10-cm line between the "no satisfaction" anchor (score 0) and the patient's mark, providing a range of scores from 0-10. The maximum of satisfaction is scored 10. The mean of satisfaction intensities of all patients at each control will be classified according to the following cut points: 0-0.4 cm: no satisfaction, 0.5-4.4 cm: low satisfaction, 4.5-7.4 cm: moderate satisfaction, and 7.5-10 cm: high satisfaction.

    Time frame: 6 and 12 months

07

Study locations

1 site
  • Ardentis Clinique Dentaire
    Écublens, 1024, Switzerland
08

Updates

1 registry update since Sep 25, 2026
Sites
1 site added, 1 site removed
Show site
  • Ardentis Clinique Dentaire · Écublens, Switzerland
Show 1 removed
  • Ardentis Clinique Dentaire · Ecublens, Switzerland
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    1 site added, 1 site removed
    Show site
    • Ardentis Clinique Dentaire · Écublens, Switzerland
    Show 1 removed
    • Ardentis Clinique Dentaire · Ecublens, Switzerland
    + 4 other changes: index terms, identifiers, verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT03967002
Lead sponsor
Ardentis Cliniques Dentaires
Responsible party
Sponsor
First posted
May 29, 2019
Start date
Sep 1, 2019
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Marion Paris, DMD
principal investigator · Oral surgeon

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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