Dental ResearchCORTICONCT03967002
Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery
A study testing Test group with corticotomy surgery in people with Dental Research and Orthodontics, run by Ardentis Cliniques Dentaires at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Research, Orthodontics, Surgery, Oral
- What is being tested?
- Test group with corticotomy surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2019to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Minimally Invasive Corticotomy Surgery in the Orthodontic Treatment of Mandibular Dental Crowding: A Randomized Prospective Study
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.
- Being tested
- Test group with corticotomy surgery
- Keywords
- Accelerated orthodontics, Alveolar corticotomy, Piezoelectric surgery, Tooth movement, Dental crowding, Guided surgery, Minimally invasive oral surgery, Mandibular anterior alignment, Randomized prospective study
- Medical subject headings
- Tooth Diseases, Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test group with corticotomy surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Test group with corticotomy surgery | Experimental | Orthodontic treatment and minimally invasive corticotomy surgery with piezoelectric device and surgical guide Receives: Procedure: Test group with corticotomy surgery |
| Control group without corticotomy surgery | No intervention | Standard orthodontic treatment without surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 2 weeks, and 1, 2, 3, 4, 5, 6 and 12 months
Secondary outcomes (7)
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.
Measured: Baseline, 6 and 12 months
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.
Measured: Baseline, 6 and 12 months
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.
Measured: Baseline, 6 and 12 months
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).
Measured: Baseline and 6 months
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.
Measured: Baseline, after surgery, after appliance of orthodontic material, 1 week, 2 weeks, and 1, 2, 3, 4, 5, 6 and 12 months
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.
Measured: Baseline, after surgery, after appliance of orthodontic material, 1 week, 2 weeks, and 1, 2, 3, 4, 5, 6 and 12 months
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.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Sep 2019
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ardentis Cliniques Dentaires
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Responsible party
- Sponsor
- Investigators
- Marion Paris, DMD, Principal investigator, Oral surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967002
- Sponsor's protocol ID
- Study CORTICO
- Other IDs
- 2019-00160, 2019
- Acronym
- CORTICO
- Status last verified
- Nov 2026
- First submitted
- 21 May 2019
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Minimally Invasive Corticotomy Surgery in the Orthodontic Treatment of Mandibular Dental Crowding: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT03967002
- Acronym / sponsor ID
- CORTICO / Study CORTICO
- Keywords
- Accelerated orthodontics, Alveolar corticotomy, Piezoelectric surgery, Tooth movement, Dental crowding, Guided surgery, Minimally invasive oral surgery, Mandibular anterior alignment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Ardentis Cliniques DentairesIndustry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group with corticotomy surgery | Experimental | Procedure: Test group with corticotomy surgeryOrthodontic treatment and minimally invasive corticotomy surgery with piezoelectric device and surgical guide |
| Control group without corticotomy surgery | No intervention | –Standard orthodontic treatment without surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test group with corticotomy surgeryThe 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. | Procedure or surgery | Test group with corticotomy surgery |
Primary outcome
Change from baseline tooth alignment at 12 months during the correction of the crowding in the anterior mandible.
Time frame: Baseline, 2 weeks, and 1, 2, 3, 4, 5, 6 and 12 months
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).
7 secondary outcomes
Change from baseline plaque index at 12 months.
Time frame: Baseline, 6 and 12 months
Change from baseline modified sulcus bleeding index at 12 months.
Time frame: Baseline, 6 and 12 months
Change from baseline pocket probing depth at 12 months.
Time frame: Baseline, 6 and 12 months
Change from baseline bone levels to 6 months.
Time frame: Baseline and 6 months
Time-to-event of complications and adverse events
Time frame: Baseline, after surgery, after appliance of orthodontic material, 1 week, 2 weeks, and 1, 2, 3, 4, 5, 6 and 12 months
Pain intensity measures: analog visual scale
Time frame: Baseline, after surgery, after appliance of orthodontic material, 1 week, 2 weeks, and 1, 2, 3, 4, 5, 6 and 12 months
Satisfaction measures: analog visual scale
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Paris, DMD principal investigator
Oral surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test group with corticotomy surgery in people with Dental Research and Orthodontics, run by Ardentis Cliniques Dentaires at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline tooth alignment at 12 months during the correction of the crowding in the anterior mandible. (time frame: Baseline, 2 weeks, and 1, 2, 3, 4, 5, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.